thiopental


Generic Name: thiopental (THYE oh PEN tal)
Brand Names: Pentothal

What is thiopental?

Thiopental is in a group of drugs called barbiturates (bar-BIT-chur-ates). Thiopental slows the activity of your brain and nervous system.

Thiopental is used to help you relax before you receive general anesthesia with an inhaled medication.

Thiopental may be used for other purposes not listed in this medication guide.

What is the most important information I should know about thiopental? You should not receive this medication if you are allergic to thiopental or other barbiturates such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton).

You also should not receive thiopental if you have liver disease, Addison's disease, a severe thyroid disorder (myxedema), severe heart disease, severe low blood pressure, a severe breathing disorder, or a history of porphyria (an enzyme disorder that often causes blue discoloration of the skin).

Avoid drinking alcohol for at least 24 hours after you leave the hospital or surgery center. Thiopental can cause severe drowsiness or dizziness, which may last for several hours. You will need someone to drive you home after your surgery or procedure. Do not drive yourself or do anything that requires you to be awake and alert for at least 24 hours. What should I discuss with my health care provider before I receive thiopental? You should not receive this medication if you are allergic to thiopental or other barbiturates such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton), or if you have:

liver disease;

Addison's disease;

severe thyroid disorder (myxedema);

severe heart disease;

severe low blood pressure;

a severe breathing disorder; or

a history of porphyria (an enzyme disorder that often causes blue discoloration of the skin).

Tell your doctor if you have any of the conditions listed above.

FDA pregnancy category C. Thiopental may be harmful to an unborn baby. Tell your doctor if you are pregnant before you receive this medication. Thiopental can pass into breast milk and may harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby. How is thiopental given?

Thiopental is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or surgical setting.

You will be given this medication while you are lying down. You will fall asleep very quickly after thiopental is injected.

Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of thiopental.

What happens if I miss a dose?

Since thiopental is usually given just for anesthesia, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of thiopental is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

What should I avoid after receiving thiopental? Avoid drinking alcohol for at least 24 hours after you leave the hospital or surgery center. Thiopental can cause severe drowsiness or dizziness, which may last for several hours. You will need someone to drive you home after your surgery or procedure. Do not drive yourself or do anything that requires you to be awake and alert for at least 24 hours. Thiopental side effects You will remain under constant supervision during treatment with thiopental. Your caregivers will watch for any serious side effects. Tell your caregivers at once if you feel severe pain while receiving this medication.

Less serious side effects may include:

coughing;

sneezing; or

hiccups.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Thiopental Dosing Information

Usual Adult Dose for Anesthesia:

When used for induction in balanced anesthesia with a skeletal muscle relaxant and an inhalation agent:
The total dose can be estimated and then injected in two to four fractional doses. With this technique, brief periods of apnea may occur which may require assisted or controlled pulmonary ventilation. As an initial dose, 210 to 280 mg (3 to 4 mg/kg) is usually required for rapid induction in the average adult (70 kg).
When used as the sole anesthetic agent:
Moderately slow induction can usually be accomplished in the "average" adult by injection of 50 to 75 mg (2 to 3 mL of a 2.5% solution) at intervals of 20 to 40 seconds, depending on the reaction of the patient. Once anesthesia is established, additional injections of 25 to 50 mg can be given whenever the patient moves. The desired level of anesthesia can be maintained by injection of small repeated doses as needed or by using a continuous intravenous drip in a 0.2% or 0.4% concentration. With continuous drip, the depth of anesthesia is controlled by adjusting the rate of infusion.

Usual Adult Dose for Seizures:

For the control of convulsive states following anesthesia (inhalation or local) or other causes, 75 to 125 mg (3 to 5 mL of a 2.5% solution) should be given as soon as possible after the convulsion begins. Convulsions following the use of a local anesthetic may require 125 to 250 mg given over a ten minute period.

Usual Adult Dose for Coma Induction:

In neurosurgical patients, intermittent bolus injections of 1.5 to 3.5 mg/kg of body weight may be given to reduce intraoperative elevations of intracranial pressure, if adequate ventilation is provided.

Usual Adult Dose for Psychosis:

For narcoanalysis and narcosynthesis in psychiatric disorders, premedication with an anticholinergic agent may precede administration of thiopental. After a test dose, thiopental is injected at a slow rate of 100 mg/min (4 mL/min of a 2.5% solution) with the patient counting backwards from 100. Shortly after counting becomes confused but before actual sleep is produced, the injection is discontinued. Allow the patient to return to a semidrowsy state where conversation is coherent. Alternatively, thiopental may be administered by rapid IV drip using a 0.2% concentration in 5% dextrose and water. At this concentration, the rate of administration should not exceed 50 mL/min.

Usual Pediatric Dose for Anesthesia:

Induction anesthesia:
less than 1 month: 3 to 4 mg/kg intravenously
less than 1 year: 5 to 8 mg/kg intravenously
1 year to 12 years: 5 to 6 mg/kg intravenously
over 12 years: 3 to 5 mg/kg intravenously
Maintenance anesthesia:
1 year and older: 1 mg/kg intravenously as needed

Usual Pediatric Dose for Seizures:

1 year or older: 2 to 3 mg/kg/dose intravenously, repeat as needed.

Usual Pediatric Dose for Head Injury:

1 year or older: 1.5 to 5 mg/kg/dose intravenously; repeat as needed to control intracranial pressure - larger doses (30 mg/kg) to induce coma after hypoxic-ischemic injury do not appear to improve neurologic outcome.

What other drugs will affect thiopental?

Tell your doctor about all other medications you use, especially:

blood pressure medication; or

a diuretic (water pill).

This list is not complete and there may be other drugs that can interact with thiopental. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More thiopental resources Thiopental Side Effects (in more detail) Thiopental Dosage Thiopental Use in Pregnancy & Breastfeeding Thiopental Drug Interactions Thiopental Support Group 1 Review for Thiopental - Add your own review/rating Thiopental MedFacts Consumer Leaflet (Wolters Kluwer) Pentothal Prescribing Information (FDA) Pentothal Monograph (AHFS DI) Compare thiopental with other medications Anesthesia Anesthetic Adjunct Coma Induction Head Injury Psychosis Seizures Where can I get more information? Your doctor or pharmacist can provide more information about thiopental.

See also: thiopental side effects (in more detail)


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Rifamycin derivatives


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Rifamycin derivatives are antibiotics that work by binding to and inhibiting the mycobacterial DNA dependent RNA polymerase. These antibiotics are bacteriocidal and therefore extremely effective antituberculosis agents, but resistance can develop rapidly if used as a single agent. They easily penetrate into cells, body fluids and cerebrospinal fluid so can be used against organisms in the extracellular component and those that may be present in cells such as macrophages. Rifamycin antibiotics should be used throughout the course of tuberculosis treatment, which can be between nine months to a year.

See also

Medical conditions associated with rifamycin derivatives:

Bartonellosis Endocarditis Haemophilus influenzae Prophylaxis Legionella Pneumonia Leprosy Leprosy, Borderline Leprosy, Tuberculoid Meningitis Meningococcal Meningitis Prophylaxis Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Nasal Carriage of Staphylococcus aureus Tuberculosis, Active Tuberculosis, HIV Positive Tuberculosis, Latent Tuberculosis, Prophylaxis Drug List: Rifadin Mycobutin Priftin Rifadin-Iv Rimactane
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troleandomycin


Generic Name: troleandomycin (troe lee an doe MYE sin)
Brand Names: Tao

What is troleandomycin?

Troleandomycin is in a class of drugs called macrolide antibiotics. It fights bacteria in the body.

Troleandomycin is used to treat many different types of bacterial infections, such as tonsillitis, bronchitis, sinusitis, and pneumonia.

Troleandomycin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about troleandomycin? Take all of the troleandomycin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. What should I discuss with my healthcare provider before taking troleandomycin?

Before taking troleandomycin, tell your doctor if you have liver disease. You may not be able to take troleandomycin, or you may require special monitoring during therapy.

It is not known whether troleandomycin will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is also not known whether troleandomycin passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take troleandomycin?

Take troleandomycin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water. Take all of the troleandomycin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Store this medication at room temperature away from moisture and heat.

See also: Troleandomycin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a troleandomycin overdose might include nausea, vomiting, diarrhea, and abdominal discomfort.

What should I avoid while taking troleandomycin? Avoid prolonged exposure to sunlight. Troleandomycin may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Troleandomycin side effects If you experience any of the following serious side effects, stop taking troleandomycin and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

liver problems (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take troleandomycin and talk to your doctor if you experience

nausea, vomiting, diarrhea, or abdominal pain;

dizziness, fatigue, or headache; or

vaginal yeast infection.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Troleandomycin Dosing Information

Usual Adult Dose for Pneumonia:

250 to 500 mg orally 4 times a day.

Usual Adult Dose for Streptococcal Infection:

250 to 500 mg orally 4 times a day.

Usual Pediatric Dose for Pneumonia:

The safety and efficacy of troleandomycin in children
>= 1 year: 125 to 250 mg every 6 hours.
When used in streptococcal infections, therapy should be continued for 10 days.

Usual Pediatric Dose for Streptococcal Infection:

The safety and efficacy of troleandomycin in children
>= 1 year: 125 to 250 mg every 6 hours.
When used in streptococcal infections, therapy should be continued for 10 days.

What other drugs will affect troleandomycin?

Before taking troleandomycin, tell your doctor if you are taking any of the following drugs:

a seizure medication such as carbamazepine (Tegretol), phenytoin (Dilantin), or valproic acid (Depakote, Depakene);

the asthma medication theophylline (Theo-Dur, Theolair, Theochron, others);

the anticoagulant (blood thinner) warfarin (Coumadin); or

another antibiotic.

Drugs other than those listed here may also interact with troleandomycin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More troleandomycin resources Troleandomycin Dosage Troleandomycin Drug Interactions Troleandomycin Support Group 0 Reviews for Troleandomycin - Add your own review/rating Compare troleandomycin with other medications Pneumonia Streptococcal Infection Where can I get more information? Your pharmacist has additional information about troleandomycin written for health professionals that you may read. What does my medication look like?

Troleandomycin is available with a prescription under the brand name Tao. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Tao 250 mg--white capsules


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Vitamin E Suspension 100mg / ml (Cambridge Laboratories)


1. Name Of The Medicinal Product

Vitamin E Suspension 100mg/ml

2. Qualitative And Quantitative Composition

Each 5ml of suspension contains 500mg of DL-alpha-tocopheryl acetate.

3. Pharmaceutical Form

Oral Suspension

4. Clinical Particulars 4.1 Therapeutic Indications

For the correction of Vitamin E deficiency occurring in malabsorption disorders ie. cystic fibrosis, chronic cholestasis and abetalipoproteinaemia.

4.2 Posology And Method Of Administration

Route of administration: For oral use.

Adults (including the elderly)

For the treatment of malabsorption disorders the following doses should be administered:

Cystic fibrosis 100-200mg/day

Abetalipoproteinaemia 50-100mg/kg/day

Children

For the treatment of cystic fibrosis a dose of 50mg/day should be given to children less than 1 year and 100mg/day to children 1 year and over.

The adult dosage should be used for the treatment of abetalipoproteinaemia (50-100mg/kg/day).

Infants with vitamin E deficiency which is secondary to chronic cholestasis may be treated with doses of 150-200mg/kg/day.

4.3 Contraindications

Use in patients with a known hypersensitivity to Vitamin E.

4.4 Special Warnings And Precautions For Use

Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition, including patients taking oestrogens. This finding has not been confirmed but should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens.

A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than 1.5kg) treated with vitamin E.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Vitamin E may increase the risk of thrombosis in patients taking oestrogens (see 4.4 above).

4.6 Pregnancy And Lactation

There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from animal work that it is free from hazard, therefore do not use in pregnancy especially in the first trimester. No information is available on excretion in breast milk, therefore it is advisable not to use during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Diarrhoea and abdominal pain may occur with doses greater than 1g daily.

4.9 Overdose

Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The exact role of vitamin E in the animal organism has not yet been established. Vitamin E is known to exert an important physiological function as an antioxidant for fats, with a sparing action on vitamin A, carotenoids and on unsaturated fatty acids. Other work has demonstrated that vitamin E is connected with the maintenance of certain factors essential for the normal metabolic cycle.

5.2 Pharmacokinetic Properties

Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Castor oil polyethylene glycol ether

Benzoic acid

Sorbic acid

Glycerol

Syrup

Flavour raspberry

Purified Water

6.2 Incompatibilities

None.

6.3 Shelf Life

Unopened: Two years.

After first opening: One month (The product will be stable after opening for the normal duration of treatment providing the cap is replaced after use and the recommended storage conditions on the label are observed).

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Amber glass bottles with aluminium screw caps or Vistop tamper-evident caps.

6.6 Special Precautions For Disposal And Other Handling

Vitamin E Suspension may be diluted with Syrup BP but should be used immediately and not stored.

7. Marketing Authorisation Holder

Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear

NE28 9NX

8. Marketing Authorisation Number(S)

PL 12070/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

8 March 1993

10. Date Of Revision Of The Text

March 2000


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Tamiflu Suspension


Pronunciation: OH-sel-TAM-i-vir
Generic Name: Oseltamivir
Brand Name: Tamiflu
Tamiflu Suspension is used for:

Treating influenza, including H1N1 influenza (swine flu), in patients 1 year of age and older who have had symptoms for no more than 2 days. It may also be used to prevent influenza in patients 1 year of age and older.

Tamiflu Suspension is an antiviral. It works by stopping the flu virus from reproducing within the body.

Do NOT use Tamiflu Suspension if: you are allergic to any ingredient in Tamiflu Suspension you are going to have an intranasal live attenuated influenza vaccine (LAIV) within the next 2 days or you have had such a vaccine within the past 2 weeks

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tamiflu Suspension:

Some medical conditions may interact with Tamiflu Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney problems, liver problems, heart problems, breathing problems, or mood or mental problems

Some MEDICINES MAY INTERACT with Tamiflu Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Intranasal live attenuated influenza vaccine (LAIV) because its effectiveness may be decreased by Tamiflu Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tamiflu Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tamiflu Suspension:

Use Tamiflu Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tamiflu Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Shake well before each use. Use the measuring device that is provided with Tamiflu Suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you are taking Tamiflu Suspension to treat the flu, start taking it as soon as possible from when you begin noticing flu symptoms. If you are using Tamiflu Suspension to prevent the flu, start taking it as soon as possible, as directed by your doctor. Take Tamiflu Suspension on a regular schedule to get the most benefit from it. To clear up your infection completely, take Tamiflu Suspension for the full course of treatment. Keep taking it even if you feel better in a few days. Continue to take Tamiflu Suspension even if you feel well. Do not miss any doses. If you miss a dose of Tamiflu Suspension, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tamiflu Suspension.

Important safety information: Tamiflu Suspension is effective against influenza types A (including H1N1 influenza [swine flu]) and B. Tamiflu Suspension may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tamiflu Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tamiflu Suspension may cause dizziness or lightheadedness; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Tamiflu Suspension will not prevent you from spreading influenza to others. Tamiflu Suspension works only against influenza types A and B; it does not treat bacterial or other viral infections. Patients with flu who take Tamiflu Suspension may have an increased risk of confusion and unusual behavioral changes. The risk may be greater in children. Contact your doctor if you notice symptoms of confusion or any other unusual behavioral changes. Tell your doctor or dentist that you take Tamiflu Suspension before you receive any medical or dental care, emergency care, or surgery. Tell your doctor that you take Tamiflu Suspension before you receive any vaccines, including the intranasal live attenuated influenza vaccine (LAIV). Tamiflu Suspension is not a substitute for a flu vaccine. Continue to get an annual flu shot if your doctor has recommended it. If your symptoms do not get better within a few days or if they get worse, check with your doctor. Tamiflu Suspension has sorbitol in it. If you have hereditary fructose intolerance, check with your doctor or pharmacist before you use Tamiflu Suspension. Tamiflu Suspension should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tamiflu Suspension while you are pregnant. It is not known if Tamiflu Suspension is found in breast milk. If you are or will be breast-feeding while you use Tamiflu Suspension, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Tamiflu Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal behavior; confusion; hallucinations; mood or mental changes; reddened, blistered, peeling, or swollen skin; seizures; severe or persistent nausea, vomiting, or diarrhea; symptoms of infection (eg, fever, chills, persistent sore throat).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tamiflu side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea or vomiting.

Proper storage of Tamiflu Suspension:

Store Tamiflu Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Tamiflu Suspension should be used within 10 days of preparation. Keep Tamiflu Suspension out of the reach of children and away from pets.

General information: If you have any questions about Tamiflu Suspension, please talk with your doctor, pharmacist, or other health care provider. Tamiflu Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Tamiflu Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tamiflu resources Tamiflu Side Effects (in more detail) Tamiflu Use in Pregnancy & Breastfeeding Drug Images Tamiflu Drug Interactions Tamiflu Support Group 20 Reviews for Tamiflu - Add your own review/rating Compare Tamiflu with other medications Avian Influenza Influenza Influenza Prophylaxis Swine Flu
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Folic Acid 5mg Tablets (Wockhardt UK Ltd)


FOLIC ACID 5MG TABLETS

Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.

The Name Of Your Medicine Is Folic Acid 5Mg Tablets

Folic Acid 5mg Tablets contain the active ingredient folic acid. The tablet comes in one strength, 5mg.

Other ingredients in your tablet are lactose, maize starch, acacia spray-dried, magnesium stearate and stearic acid.

Folic Acid 5mg Tablets are plain yellow, biconvex tablets with breakline on one face and CP on the reverse.

Folic Acid 5mg Tablets are available in polypropylene or polyethylene tablet containers containing 100, 500 or 1000 tablets, glass bottles containing 100, 500 or 1000 tablets and blister packs containing 28 tablets.

Marketing Authorisation Holder: Wockhardt UK Limited Ash Road North Wrexham LL13 9UF UK Manufacturer: CP Pharmaceuticals Limited Ash Road North Wrexham LL13 9UF UK How Does Your Medicine Work?

Folic acid is a vitamin used to prevent or treat a deficiency (lack) of folic acid in the body.

What Are Folic Acid 5Mg Tablets For?

Folic Acid 5mg Tablets are used in adults and children for the treatment and prevention of folic acid deficiency which causes anaemia. This tends to occur in pregnancy, in patients on kidney dialysis and during treatment with some medicines.

Folic acid is also given to some women before and during pregnancy to prevent spina bifida (an abnormality of the spine) in babies, which can be caused by deficiency of this vitamin.

Before Taking This Medicine

You should not take Folic Acid 5mg Tablets if you have ever had a reaction to or been told that you are allergic to folic acid or any of the other ingredients in the tablet. Check by reading the list of ingredients above.

Before taking this medicine, you should let your doctor know if you are pregnant or breast-feeding or wish to become pregnant or start breast-feeding.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking another medicine while you are taking folic acid can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking Folic Acid 5mg Tablets unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.

Examples of medicines that can affect Folic Acid 5mg Tablets are; Certain antibiotics (trimethoprim and sulphonamides, sometimes combined as co-trimoxazole). Some drugs used in the treatment of epilepsy (phenytoin, phenobarbital and primidone). Fluorouracil, a drug used to treat certain tumours. Some indigestion remedies (edible clay and antacids containing aluminium or magnesium). Allow at least a two hour gap between taking your Folic Acid Tablets and indigestion remedies. Preparations containing zinc such as vitamins or food supplements (this may be important in pregnancy).

If you have any doubts about whether you should take this medicine then talk to your doctor.

Advice When Taking Folic Acid 5Mg Tablets Patients with pernicious anaemia (or the possibility of pernicious anaemia) should be given Vitamin B12 as well as folic acid. Care needs to be taken in patients with certain tumours. Taking This Medicine

In adults and children over one year, the usual dose of Folic Acid 5mg Tablets is one tablet a day for the treatment of anaemia or one tablet every one to seven days for the prevention of anaemia.

Children under one year should be given 500 micrograms per kilogram of body weight daily.

The usual dose for the prevention of spina bifida is one tablet a day, starting before conception and continuing for the first three months of pregnancy.

To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.

Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow any instructions or warnings that appear on the label that the pharmacist may put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless told otherwise, take your tablet with water.

You should take your medicine for as long as your doctor tells you to. If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first.

If you accidentally take too many tablets you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

Are There Any Side-Effects?

Like many medicines Folic Acid 5mg Tablets may cause side-effects in some patients, particularly when you first start taking them. The side-effects that some other patients have had with Folic Acid 5mg Tablets include loss of appetite, feeling sick, bloating of the stomach and wind. Allergic reactions are rare.

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

Safe Keeping For This Medicine

Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of “going off” such as discoloration.

These tablets should not be stored above 25°C. Store in the original package in order to protect from light. Do not transfer Folic Acid 5mg Tablets to another container.

Keep Folic Acid 5mg Tablets out of the reach and sight of children.

Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Unless your doctor tells you to, do not keep medicines that you no longer need. Give them back to your pharmacist.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name
Folic Acid 5mg Tablets

Reference Number
29831/0097

This is a service provided by the Royal National Institute of the Blind.

DATE OF REVISION September 2007

CP1

103583/1


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Zymaxid


Generic Name: gatifloxacin (Ophthalmic route)

gat-i-FLOX-a-sin

Commonly used brand name(s)

In the U.S.

Zymar Zymaxid

Available Dosage Forms:

Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Zymaxid

Gatifloxacin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.

This medicine is available only with your doctor's prescription.

Before Using Zymaxid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zymaxid™ in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Zymaxid™ in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of gatifloxacin

This section provides information on the proper use of a number of products that contain gatifloxacin. It may not be specific to Zymaxid. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection. If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic dosage form (eye drops): For bacterial conjunctivitis: Adults and children 1 year of age and older— Day 1: Put one drop in the affected eye every two hours while awake, up to 8 times. Days 2 through 7: Put one drop in the affected eye two to four times a day while awake. Infants younger than 1 year of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zymaxid

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Zymaxid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Eye irritation eye pain eye redness Less common Bloody eye decrease in vision swelling of the membrane covering the white part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision discharge from the eyes itching eyes stringy mucus secretions swelling of the eye, eyelid, or inner lining of the eyelid watering eyes Less common Bad, unusual, or unpleasant (after) taste change in taste dry eye headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zymaxid side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zymaxid resources Zymaxid Side Effects (in more detail) Zymaxid Use in Pregnancy & Breastfeeding Zymaxid Support Group 0 Reviews for Zymaxid - Add your own review/rating Zymaxid Consumer Overview Zymaxid Prescribing Information (FDA) Zymar Prescribing Information (FDA) Zymar eent Monograph (AHFS DI) Zymar Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare Zymaxid with other medications Conjunctivitis Conjunctivitis, Bacterial
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Zymar


Generic Name: gatifloxacin (Ophthalmic route)

gat-i-FLOX-a-sin

Commonly used brand name(s)

In the U.S.

Zymar Zymaxid

Available Dosage Forms:

Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Zymar

Gatifloxacin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.

This medicine is available only with your doctor's prescription.

Before Using Zymar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zymaxid™ in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Zymaxid™ in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of gatifloxacin

This section provides information on the proper use of a number of products that contain gatifloxacin. It may not be specific to Zymar. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection. If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic dosage form (eye drops): For bacterial conjunctivitis: Adults and children 1 year of age and older— Day 1: Put one drop in the affected eye every two hours while awake, up to 8 times. Days 2 through 7: Put one drop in the affected eye two to four times a day while awake. Infants younger than 1 year of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zymar

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Zymar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Eye irritation eye pain eye redness Less common Bloody eye decrease in vision swelling of the membrane covering the white part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision discharge from the eyes itching eyes stringy mucus secretions swelling of the eye, eyelid, or inner lining of the eyelid watering eyes Less common Bad, unusual, or unpleasant (after) taste change in taste dry eye headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zymar side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zymar resources Zymar Side Effects (in more detail) Zymar Use in Pregnancy & Breastfeeding Zymar Support Group 6 Reviews for Zymar - Add your own review/rating Zymar Prescribing Information (FDA) Zymar eent Monograph (AHFS DI) Zymar Drops MedFacts Consumer Leaflet (Wolters Kluwer) Zymaxid Prescribing Information (FDA) Zymaxid Consumer Overview Compare Zymar with other medications Conjunctivitis Conjunctivitis, Bacterial Ophthalmic Surgery
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Lamisil AT 1% Spray


1. Name Of The Medicinal Product

Lamisil® AT 1% Spray

2. Qualitative And Quantitative Composition

10mg terbinafine hydrochloride per 1g spray solution

For excipients, see Section 6.1.

3. Pharmaceutical Form

Cutaneous spray, solution

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris, (dhobie (jock) itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Spray is applied once daily, for one week. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week.

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted.

Use of Lamisil AT 1% Spray in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Use of Lamisil AT 1% Spray in children

Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended.

4.3 Contraindications

Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see 6.1 List of excipients).

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% Spray should be used with caution in patients with lesions where alcohol could be irritating.

Lamisil AT 1% Spray is for external use only. It may be irritating to the eyes. Lamisil AT 1% Spray should not be used on the face.

In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist.

Lamisil AT 1% Spray should be kept out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interactions are known with Lamisil AT 1% Spray, however as a precaution it is recommended that other medicinal products are not applied on the treated areas.

4.6 Pregnancy And Lactation

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine. No cases of malformations in humans have been reported with Lamisil to date. However, since clinical experience in pregnant women is very limited, Lamisil AT 1% Spray should be used only if clearly indicated during pregnancy. Terbinafine is excreted in breast milk and therefore, mothers should not receive Lamisil AT 1% Spray whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Redness, itching or stinging may occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptoms must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No case of overdosage has been reported with Lamisil AT 1% Spray. Should, however, Lamisil AT 1% Spray be inadvertently ingested, adverse effects similar to those observed with an overdosage of Lamisil Tablets (e.g. headache, nausea, epigastric pain and dizziness) are to be expected. The alcohol content (23.5%) of the spray solution has to be taken into account.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01 A)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is thus very slight.

5.3 Preclinical Safety Data

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water

Ethanol (23.5% w/w)

Propylene glycol

Cetomacrogol 1000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30°C. Do not refrigerate.

6.5 Nature And Contents Of Container

Lamisil AT 1% Spray is available as a white round HDPE bottle with a crimped mouth and spray pump in pack sizes of 15ml and 30ml.

6.6 Special Precautions For Disposal And Other Handling

See 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use.

For manipulation of the spray pump the bottle can be held in the upright or inverted position.

When using Lamisil AT 1% Spray for the first time, the patient will need to depress the actuator a few times (usually up to 3 actuations) before the solution is dispensed.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd.

Wimblehurst Road

Horsham

RH12 5AB

UK

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

7th December 2001

10. Date Of Revision Of The Text

27th April 2009

Legal Category: GSL


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Influenza Virus Vaccine


Pronunciation: IN-floo-EN-za
Generic Name: Influenza Virus Vaccine
Brand Name: Fluzone Intradermal
Influenza Virus Vaccine is used for:

Protecting against certain strains of influenza (flu) in patients between 18 and 64 years old.

Influenza Virus Vaccine is a vaccine. It works by stimulating the body to produce antibodies against certain types of the flu virus, which helps your body to fight the infection.

Do NOT use Influenza Virus Vaccine if: you are allergic to any ingredient in Influenza Virus Vaccine, including egg proteins, or to egg products you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a prior flu vaccination

Contact your doctor or health care provider right away if any of these apply to you.

Before using Influenza Virus Vaccine:

Some medical conditions may interact with Influenza Virus Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a fever, cold, respiratory tract infection, or other infection or recent illness if you have asthma or other breathing problems, a nervous system disorder, or blood or bleeding problems (eg, hemophilia, low blood platelet levels) if you have cancer or immune system problems (eg, HIV, weakened immune system) if you are receiving radiation treatment or chemotherapy if you have a history of Guillain-Barr?© syndrome

Some MEDICINES MAY INTERACT with Influenza Virus Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Corticosteroids (eg, prednisone) or other medicines that may weaken the immune system because they may decrease Influenza Virus Vaccine's effectiveness. Ask your doctor if you are unsure if any of your medicines may weaken the immune system

This may not be a complete list of all interactions that may occur. Ask your health care provider if Influenza Virus Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Influenza Virus Vaccine:

Use Influenza Virus Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Influenza Virus Vaccine is usually given once a year in September, October, or November. Influenza Virus Vaccine is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions. Do not use Influenza Virus Vaccine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. If you miss a dose of Influenza Virus Vaccine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Influenza Virus Vaccine.

Important safety information: If you have a fever, cold, respiratory tract infection, or other illness, contact your doctor before you receive Influenza Virus Vaccine. You may need to receive your injection at a later time. Influenza Virus Vaccine contains killed viruses. It cannot cause you to develop the flu. Influenza Virus Vaccine is not a cure for the flu. It must be given before you are exposed to the flu in order to be effective. Influenza Virus Vaccine is only effective for 1 flu season. You will need to receive the flu vaccine each year. Influenza Virus Vaccine is not effective against all strains of the flu virus. It may also not protect everyone who receives it. Influenza Virus Vaccine does not protect against other respiratory viruses. Tell your doctor if you will be receiving any other vaccines. Caution is advised when using Influenza Virus Vaccine in CHILDREN; they may be more sensitive to its effects, especially injection-site reactions. Influenza Virus Vaccine should be used with extreme caution in CHILDREN younger than 18 years old and in ELDERLY patients older than 64 years old; safety and effectiveness in these patients have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Influenza Virus Vaccine while you are pregnant. It is not known if Influenza Virus Vaccine is found in breast milk. If you are or will be breast-feeding while you use Influenza Virus Vaccine, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Influenza Virus Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

General body discomfort; headache; mild fever; mild itching, pain, redness, swelling, tenderness, or hardening of the skin at the injection site; muscle aches; shivering.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache or fever; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Influenza Virus Vaccine:

Influenza Virus Vaccine is usually handled and stored by a health care provider. If you are using Influenza Virus Vaccine at home, store Influenza Virus Vaccine as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information: If you have any questions about Influenza Virus Vaccine, please talk with your doctor, pharmacist, or other health care provider. Influenza Virus Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Influenza Virus Vaccine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Influenza Virus Vaccine resources Influenza Virus Vaccine Use in Pregnancy & Breastfeeding Influenza Virus Vaccine Drug Interactions Influenza Virus Vaccine Support Group 1 Review for Influenza Virus - Add your own review/rating Compare Influenza Virus Vaccine with other medications Influenza Prophylaxis
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ProHance Vials


1. Name Of The Medicinal Product

ProHance

2. Qualitative And Quantitative Composition

Gadoteridol 279.3mg/ml (0.5M)

3. Pharmaceutical Form

Sterile solution for intravenous injection

4. Clinical Particulars 4.1 Therapeutic Indications

Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier.

ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies.

4.2 Posology And Method Of Administration

Adults

The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg. However, doses of 0.3 mmol/kg have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions.

The recommended dose for whole body MRI is 0.1 mmol/kg.

Children (2 years and above)

The recommended dose of ProHance for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 ml/kg).

ProHance has been used in only a limited number of children aged between 6 months and 2 years. If an MRI procedure must be performed in this group, particular caution should be exercised.

The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established.

To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance.

Special Populations

Impaired renal function

ProHance should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If it is necessary to use ProHance, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Use of ProHance is not recommended in children less than 6 months of age.

Use for whole body MRI is not recommended in children less than 18 years of age

Elderly (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

4.3 Contraindications

A history of previous hypersensitivity to ProHance, its constituents or other gadolinium-based contrast. ProHance is contraindicated in children under 6 months of age.

4.4 Special Warnings And Precautions For Use

Anaphylactic reactions have been observed following the use of gadoteridol. Appropriate drugs and instruments for emergency measures must be readily available.

Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant.

Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function.

Impaired renal function

Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.

Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration.

Elderly

As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with gadoteridol. No clinically significant changes or trends in laboratory tests were seen in clinical trials with ProHance.

4.6 Pregnancy And Lactation

Pregnancy

There are no data from the use of gadoteridol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.

Lactation

Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3). At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of ProHance, should be at the discretion of the doctor and lactating mother.

4.7 Effects On Ability To Drive And Use Machines

There are no known effects of ProHance on the ability to drive or operate machinery.

4.8 Undesirable Effects

The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement.

Side effects: Taste disturbance (primarily metallic taste) nausea, urticaria, pain at injection site, convulsions and hypotension have been reported. Headache and chest pain have been rarely reported. These occurrences were transient and resolved without residual effect. The occurrences were not related to age, gender, rate of injection or dose administered.

Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with ProHance, most of which were in patients co-administered other gadolinium-containing contrast agents (see section 4.4).

4.9 Overdose

There have been no cases of overdose reported to date, consequently, neither signs nor symptoms of overdosage have been identified. In the event of overdosage occurring, the patient should be observed and treated symptomatically.

ProHance can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Gadoteridol is a non-ionic paramagnetic contrast medium for Magnetic Resonance Imaging.

When placed in a magnetic field, gadoteridol decreases T1 relaxation times in targeted areas. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

Gadoteridol does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that have a normal blood-brain barrier, e.g. cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or normal vascularity allows penetration of gadoteridol into lesions such as neoplasms, abscesses, and subacute infarcts.

5.2 Pharmacokinetic Properties

The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two- compartment open model with mean distribution and elimination half-lives (reported as mean ± SD) of about 0.20 ± 10.04 hours and 1.57 ± 10.08 hours, respectively.

Gadoteridol is exclusively eliminated in the urine with 94.4 ± 4.8% (mean ± SD) of the dose excreted within 24 hours post injection. There is no detectable biotransformation or decomposition of gadoteridol.

The renal and plasma clearance rates (1.41 ± 0.33 ml/min/kg and 1.50 ± 0.35 ml/min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in elimination kinetics on passage through the kidneys and that the drug is essentially cleared through the kidney. The volume of distribution (204 ± 58 ml 1 kg) is equal to that of extra cellular water, and clearance is similar to that of substances which are subject to glomerular filtration.

No serum protein binding was detected in rats.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Calteridol Calcium

Tromethamine USP

Hydrochloric Acid Ph Eur

Sodium Hydroxide Ph Eur

Water for Injections Ph Eur

6.2 Incompatibilities

ProHance should not be admixed with any other drug.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at room temperature (15-30°C.), protect from light. ProHance should not be frozen.

6.5 Nature And Contents Of Container

Vials: Type 1 glass vials with grey butyl stoppers and aluminium seals containing 5,10, 15 or 20ml.

6.6 Special Precautions For Disposal And Other Handling

The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

7. Marketing Authorisation Holder

Bracco International B.V.

Strawinskylaan 3051

1077 ZX Amsterdam

The Netherlands

8. Marketing Authorisation Number(S)

14447/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

29/10/1992

10. Date Of Revision Of The Text

28/09/2010


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ustekinumab


Generic Name: ustekinumab (YOO sti KIN ue mab)
Brand names: Stelara, Stelara PFS

What is ustekinumab?

Ustekinumab is an immunosuppressant that reduces the effects of a substance in the body that can cause inflammation.

Ustekinumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.

Ustekinumab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ustekinumab? You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Gu?rin) vaccine within the past year (12 months).

Before using ustekinumab, tell your doctor if you have an active infection, a history of tuberculosis or recurrent infections, high blood pressure, a weak immune system, or if you are receiving phototherapy (light therapy).

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are current on all vaccines before you start treatment with ustekinumab.

Ustekinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, swelling or redness, pain or burning when you urinate, blood in your urine, severe stomach pain, changes in your bowel habits, cough with yellow or green mucus, stabbing chest pain, or severe headache with confusion, vision problems, or seizure.

Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

What should I discuss with my health care provider before using ustekinumab? You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Gu?rin) vaccine within the past year (12 months).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

an active infection;

a history of recurrent infections;

a history of tuberculosis;

high blood pressure;

a weak immune system; or

if you are receiving phototherapy (light therapy).

FDA pregnancy category B. Ustekinumab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ustekinumab can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use ustekinumab?

Before you start treatment with ustekinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Ustekinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection.

Ustekinumab injections are usually given every 12 weeks, but your first two injections will be 4 weeks apart. Follow your doctor's instructions.

Ustekinumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth sores, swelling or redness, severe stomach pain, cough with mucus, or severe headache. These may be early signs of a severe infection.

To be sure ustekinumab is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments. You must remain under the care of a doctor while you are receiving ustekinumab.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ustekinumab injection.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a ustekinumab overdose are not known.

What should I avoid while using ustekinumab?

Avoid injecting this medication into skin that is bruised, red, tender, or hardened.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with ustekinumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine.

BCG vaccine should not be given for at least 1 year after you receive your last dose of ustekinumab.

Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with ustekinumab.

Ustekinumab side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness;

mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;

swelling, pain, tenderness, or redness anywhere on your body;

pain or burning when you urinate, blood in your urine;

stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);

cough with yellow or green mucus;

stabbing chest pain, feeling short of breath; or

severe headache, confusion, vision problems, and/or seizure (convulsions).

Less serious side effects may include:

cold symptoms (runny or stuffy nose, sore throat);

headache, tired feeling;

mild diarrhea; or

mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ustekinumab Dosing Information

Usual Adult Dose for Psoriasis:

For use in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy:
Less than 100 kg (220 lbs):
Initial dose: 45 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 45 mg subcutaneously once every 12 weeks
Greater than 100 kg (220 lbs):
Initial dose: 90 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 90 mg subcutaneously once every 12 weeks
In subjects weighing greater than 100 kg, 45 mg was also shown to be effective. However, 90 mg resulted in greater efficacy.
The safety and efficacy of ustekinumab have not been evaluated beyond two years.

What other drugs will affect ustekinumab?

Tell your doctor about all other medications you use, especially:

drugs that weaken your immune system (such as cancer medicine or steroids);

a blood thinner such as warfarin (Coumadin);

cyclosporine (Gengraf, Neoral, Sandimmune);

digoxin (digitalis, Lanoxin, Lanoxicaps);

sirolimus (Rapamune) or tacrolimus (Prograf);

theophylline (Elixophyllin, Theo-24, Uniphyl);

seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or

a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with ustekinumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More ustekinumab resources Ustekinumab Side Effects (in more detail) Ustekinumab Dosage Ustekinumab Use in Pregnancy & Breastfeeding Ustekinumab Drug Interactions Ustekinumab Support Group 11 Reviews for Ustekinumab - Add your own review/rating ustekinumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Ustekinumab Professional Patient Advice (Wolters Kluwer) Ustekinumab MedFacts Consumer Leaflet (Wolters Kluwer) Ustekinumab Monograph (AHFS DI) Stelara Prescribing Information (FDA) Stelara Consumer Overview Compare ustekinumab with other medications Psoriasis Psoriatic Arthritis Where can I get more information? Your doctor or pharmacist can provide more information about ustekinumab.

See also: ustekinumab side effects (in more detail)


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fusidic acid Oral, Injection


fue-SID-ik AS-id

Commonly used brand name(s)

In Canada

Fucidin Suspension

Available Dosage Forms:

Suspension Syrup Powder for Solution Tablet, Enteric Coated Uses For fusidic acid

Fusidic acid is a substance that is used to treat bacterial infections. It will not work for colds, flu, or other virus infections.

Fusidic acid is available only with your doctor's prescription.

Before Using fusidic acid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fusidic acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fusidic acid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fusidic acid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fusidic acid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atorvastatin Ritonavir Saquinavir Simvastatin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fusidic acid. Make sure you tell your doctor if you have any other medical problems, especially:

Liver disease—May be worsened by fusidic acid Proper Use of fusidic acid Dosing

The dose of fusidic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fusidic acid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): Osteomyelitis (bone and joint infections) or skin and soft tissue infections: Adults—500 mg (2 tablets) three times daily For oral dosage form (suspension): Osteomyelitis (bone and joint infections) or skin and soft tissue infections: Adults—15 milliliters three times daily Children—Up to 1 year of age: 1 milliliter (mL) per kilogram DAILY divided into 3 equal doses; 1 to 5 years of age is 5 mL three times daily; 6 to 12 years of age is 10 mL three times daily. For injection dosage form: Osteomyelitis (bone and joint infections) or skin and soft tissue infections: Adults—500 milligrams three times daily Children—Up to 1 year of age to 12 years: 20 milligrams/kilogram DAILY divided into 3 equal doses, infused over at least 2 hours. Missed Dose

If you miss a dose of fusidic acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using fusidic acid

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

fusidic acid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Unusual tiredness or weakness yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Loss of appetite nausea abdominal or stomach pain increase in bowel movements loose stools

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Vagifem 25 ?g film-coated tablets


Vagifem 25 micrograms film-coated vaginal tablets

Estradiol hemihydrate

Read all of this leaflet carefully, before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. In this leaflet: 1. What Vagifem is and what it is used for 2. Before you use Vagifem 3. How to use Vagifem 4. Possible side effects 5. How to store Vagifem 6. Further information What Vagifem Is And What It Is Used For

Vagifem contains estradiol

Estradiol is a female sex hormone It belongs to a group of hormones called oestrogens It is exactly the same as the estradiol produced by the ovaries of women.

Vagifem belongs to a group of medicines called Hormone Replacement Therapy (HRT).

It is intended for post-menopausal women and is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally around the menopause.

Vagifem works by replacing the oestrogen which is normally produced in the ovaries of women.

It is inserted into your vagina, so the hormone is released where it is needed.

The experience of treating women older than 65 years is limited.

Before You Use Vagifem Medical check-ups

Before you start using Vagifem, your doctor will tell you about the risks and benefits of the treatment (see also Section 4). Before you start using Vagifem and regularly during treatment, your doctor will check whether Vagifem is the right treatment for you. Once you’ve started on HRT, your doctor will tell you how often to go for regular check-ups. At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

If you have a close relative (e.g. mother, sister, maternal or paternal grandmother), who has suffered from any serious illness such as blood clots or breast cancer, you might be at a higher risk for serious illness. Always tell your doctor about any close relative(s) suffering from serious illness.

As well as regular check-ups with your doctor, you should:

Regularly examine your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Tell your doctor if you notice any changes. Go for regular breast screening (mammography) and cervical smear tests. Do not use Vagifem if: You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem (listed in Section 6 below) You have or have ever had, or think you might have breast cancer You have or have had a hormone dependent tumour (e.g. cancer of the lining of the womb) You have unusual vaginal bleeding which you have not told your doctor about You have thickening of the lining of the womb (endometrial hyperplasia) and you are not being treated for it You have or previously have had a blood clot inside the blood vessels of the legs or lungs (deep vein thrombosis or pulmonary embolism) You have porphyria. This is a rare disease which affects the production of some of your blood pigments. You have active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) You have acute liver disease or history of liver disease as long as liver function tests have failed to return to normal

Do not use Vagifem if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Take special care with Vagifem

Check with your doctor before using Vagifem if you have or have ever had any of the illnesses in the list below. He or she may want to follow you more closely.

Asthma Epilepsy Diabetes Gallstones High blood pressure Migraines or severe headaches Liver problems such as ‘liver adenoma’ (a benign tumour) Endometrial hyperplasia (thickening of the lining of your womb) Otosclerosis. This is when you lose your hearing over a period of time Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys) Blood clots or risk factors for blood clots (see Section 4 ‘Other side effects of systemic HRT’) Leiomyoma (benign tumours of the womb) or endometriosis (growth of the womb lining outside the womb)

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Vagifem.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Do not use Vagifem if you think you might be pregnant, or if you are breast-feeding If you get pregnant while you are using Vagifem, stop using it and see a doctor straight away. Driving and using machines

No known effect.

How To Use Vagifem

Always use Vagifem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using this medicine You can start using Vagifem on any day which is best for you Insert the vaginal tablet into your vagina with the applicator.

The ’USER INSTRUCTIONS’ at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem.

How much to use Use one vaginal tablet each day for the first 2 weeks Then use one vaginal tablet twice a week. Leave 3 or 4 days between each dose. If you use more Vagifem than you should If you have used more Vagifem than you should, talk to a doctor or pharmacist. An overdose of oestrogen could make you feel sick or vomit. If you forget to use Vagifem If you forget a dose, use the medicine as soon as you remember. Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

General information about treating symptoms of the menopause When using medicines for any menopausal symptoms, use the lowest dose that works. Also, use the medicine for as short a time as you need to.

Only continue treatment if the benefit is more than the risk.

Talk to your doctor about this.

Possible Side Effects

Like all medicines, Vagifem can cause side effects, although not everybody gets them.

Stop using Vagifem and see a doctor straight away if you notice any of the following side effects: A migraine-type headache you have not had before Yellow colouring of your skin or eyes (jaundice) or other liver problems A big increase in blood pressure Blood clots called ‘deep vein thrombosis’ (see also ‘Other side effects of systemic HRT’) If you develop any of the illnesses listed in Section 2, ’Do not use Vagifem’ You become pregnant Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

Common (may affect more than 1 in 100 women)

Headache Passing wind (flatulence) Feeling sick (nausea) or being sick (vomiting) Indigestion Stomach pain, discomfort or distension Swelling of arms or legs (oedema) Vaginal bleeding, discharge or discomfort An infection of the genitals caused by a fungus or inflamed vagina Breast oedema or breast enlargement, breast pain or breast tenderness.

Very rare (may affect less than 1 in 10000 women)

Breast cancer Cancer of the lining of the womb (endometrial cancer) Thickening of the lining of your womb (endometrial hyperplasia) Blood clots called ‘deep vein thrombosis’ Other side effects of systemic HRT are: Allergic reaction (hypersensitivity) Diarrhoea Weight increase Fluid retention Being unable to sleep (insomnia) Feeling depressed Worsening of existing migraine Rash, including itchy, lumpy rash called ‘hives or urticaria’ Itching of the genitals Vaginal pain, irritation of the vagina, painful spasm of the vagina (vaginismus) or vaginal ulcers Increase in blood oestrogen (shown in blood test) Drug ineffective. Important information on the side effects of HRT

Vagifem is used for local treatment in the vagina and contains only a small amount of estradiol. This means that the chances of getting the diseases described below are less likely than with HRT products used for systemic treatment (treatment that affects the body as a whole).

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Effects on your heart or circulation

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

a pain in your chest that spreads to your arm or neck See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that systemic HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

unexplained migraine-type headaches, with or without disturbed vision See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

Systemic HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

painful swelling in your leg sudden chest pain difficulty breathing See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT.

The extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight

Compare

Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

If you notice

any changes in your breast, such as:

dimpling of the skin changes in the nipple any lumps you can see or feel Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT tablets orally for a long time can increase the risk of developing cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk with oestrogen cream/rings/tablets used directly in the vagina for repeated treatments or over a long time.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

HOW TO STORE Vagifem

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate. Keep the blisters in the outer carton in order to protect from light.

Do not use Vagifem after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Vagifem contains The active substance is estradiol 25 micrograms (as estradiol hemihydrate) Other ingredients are: hypromellose, lactose monohydrate, maize starch and magnesium stearate The film-coating contains: hypromellose and Macrogol 6000. What Vagifem looks like and content of the pack

Each Vagifem comes in an applicator which is used once only.

There are 15 applicators with vaginal tablets in each box.

Vagifem is engraved with NOVO 279.

Marketing Authorisation Holder Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark The registered office in the UK is: Novo Nordisk Limited Broadfield Park Crawley West Sussex RH11 9RT Tel:(01293) 613555

This leaflet was last approved in: 04/2010

Detailed information on this medicine is available on the web site of www.emc.medicines.org.uk

User Instructions How to use Vagifem 1. Tear off one single blister pack. Open the end as shown in the picture. 2. Insert the applicator carefully into the vagina.

Stop when you can feel some resistance.

3. To release the tablet, gently press the push button until you feel a click.

The tablet will stick to the wall of the vagina straight away.

It will not fall out if you stand up or walk.

4. Take out the applicator and throw it away

Vagifem is a trademark owned by Novo Nordisk Femcare AG, Switzerland.

© 2010

Novo Nordisk A/S

8-2790-01-033-1


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Elleste Duet Conti Tablets


Elleste DuetTM Conti Tablets

(estradiol and norethisterone acetate)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Elleste Duet Conti Tablets are and what they are used for 2. Before you take Elleste Duet Conti Tablets 3. How to take Elleste Duet Conti Tablets 4. Possible side effects 5. How to store Elleste Duet Conti Tablets 6. Further information What Elleste Duet Conti Tablets Are And What They Are Used For

Elleste Duet Conti Tablets are a form of hormone replacement therapy (HRT).

They contain two hormones, estradiol hemihydrate and norethisterone acetate. Elleste Duet Conti Tablets are one of a group of medicines called combined estrogen-progestogen preparations. They are not an oral contraceptive.

Why has your doctor given you Elleste Duet Conti Tablets?

Elleste Duet Conti Tablets treat the symptoms of the menopause (change of life) in women who are at least one year past the menopause.

As you approach the menopause, your ovaries gradually produce fewer hormones. This may cause unpleasant symptoms such as hot flushes and sweating. Elleste Duet Conti Tablets replace hormones which you lose during the menopause and prevent or relieve any unpleasant symptoms. Your doctor will aim to give you the lowest dose required to treat your symptoms.

Other changes in your bones may also take place over a longer time. These changes can lead to an increased risk of your bones breaking or cracking. If you are at an increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatments or if other therapies prove to be ineffective, Elleste Duet Conti Tablets may also be used for this purpose. Your doctor should discuss all the available options with you.

Before You Take Elleste Duet Conti Tablets

Elleste Duet Conti Tablets may not be suitable for all women. Read the list below.

DO NOT take Elleste Duet Conti Tablets, if you have, or have ever had:

a blood clot in a vein in your leg or anywhere else (a "deep vein thrombosis"); a blood clot that has travelled to your lung or another part of the body (an "embolus"); narrowed or blocked arteries possibly leading to angina and heart disease; breast or womb cancer; unexplained vaginal bleeding; liver problems, for example, jaundice (yellowing of the skin or eyes); porphyria (a rare inherited blood disease); untreated endometrial hyperplasia (an overgrowth of the lining of the womb).

Also do not take Elleste Duet Conti Tablets if you:

are pregnant or you think you could be pregnant; are breast-feeding; or have ever had an allergic reaction to any of the ingredients in Elleste Duet Conti Tablets (see Section 6).

Elleste Duet Conti Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Safety of HRT

As well as benefits, HRT has some risks which you need to consider when you're deciding whether to take it, or whether to carry on taking it.

Take special care with Elleste Duet Conti Tablets

Elleste Duet Conti Tablets might have an effect on various processes in your body. HRT should only be started for symptoms that reduce your quality of life.

Medical check-ups

Before you start taking HRT, your doctor should ask about your own and your family's medical history. Your doctor may decide to examine your breasts and/or abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

Once you've started on HRT, you should:

see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT; go for regular breast screening and cervical smear tests; regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. Effects on your heart or circulation

Heart disease:

HRT is not recommended for women who have heart disease, or have had heart disease recently.

If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

a pain in your chest that spreads to your arm or neck

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke:

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat.

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

unexplained migraine-type headaches, with or without disturbed vision

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots:

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot if you:

are seriously overweight have had a blood clot before or have a close family member who has had blood clots have had one or more miscarriages have any blood clotting problem that needs treatment with a medicine such as warfarin are off your feet for a long time because of major surgery, injury or illness have a rare condition called systematic lupus erythematosus (SLE).

If any of these apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

The following may be signs of a blood clot if you get:

painful swellling in your leg sudden chest pain difficulty breathing

See a doctor as soon as possible and do not take any more HRT until your doctor says you can.

If you're going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast cancer:

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT slightly increases the risk of breast cancer; as does having a later menopause. Your risk of breast cancer is higher if you:

have a close relative (mother, sister or grandmother) who has had breast cancer are seriously overweight.

The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who is still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogen-only HRT (but estrogen plus progestogen HRT is beneficial for the endometrium, see 'Endometrial cancer' below).

For all kinds of HRT, the extra risk of breast cancer increases the longer you take it, but returns to normal within about 5 years after stopping.

Compare

Looking at women in their 50s who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (ie an extra 1-2 cases).

If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (ie an extra 5 cases).

For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases).

If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19 cases).

If you notice any changes in your breasts such as:

dimpling of the skin changes in the nipple any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb):

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking progestogen as well as the estrogen helps to lower the extra risk.

Elleste Duet Conti Tablets also contain progestogen.

If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. These may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.

If you've had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.

Compare

Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50-65.

For women who take estrogen-only HRT, the figure will be between 10 and 60 in 1000 (ie an extra 5 to 55 cases), depending on the dose and how long you take it.

The addition of a progestogen to estrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it's usually nothing to worry about, especially during the first few months of taking HRT.

Make an appointment to see your doctor if the bleeding or spotting:

carries on for more than the first few months starts after you've been on HRT for a while carries on even after you've stopped taking HRT

It could be that your endometrium has become thicker.

Ovarian cancer:

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

While you are taking Elleste Duet Conti Tablets

Certain diseases sometimes get worse when you are taking hormone replacement therapy. Your doctor may need to check you more closely if you suffer from any of the following.

Migraine or severe headache Asthma Gallstones Epilepsy High blood pressure A personal or family history of blood clots. Diabetes (see below) Liver problems Heart or kidney problems Endometrial hyperplasia (overgrowth of the lining of your womb) Fibroids in your womb (see below) Endometriosis (where tissue from your womb is found outside the womb). A history of breast cancer in your family Systemic lupus erythematosus (SLE; a chronic inflammatory disease affecting the skin and organs) Otosclerosis (an inherited form of deafness which sometimes gets worse during pregnancy). High levels of lipids in you blood (hypertriglyceridaemia)

Elleste Duet Conti Tablets may affect the results of certain laboratory tests, so tell the person taking the sample that you are taking Elleste Duet Conti Tablets.

If you have:

fibroids (lumps of fibrous and muscular tissue) in your womb, these may increase in size when you are taking Elleste Duet Conti Tablets. See your doctor if you have any pain or swelling in your abdomen. diabetes, you may need to change the amount of insulin you take. Check your blood glucose level more often until it is steady.

Do I need to use contraception while I am taking Elleste Duet Conti Tablets?

It is important to remember that Elleste Duet Conti Tablets are not an oral contraceptive (the pill).

If you are using the pill or another hormonal contraceptive, you will need to use another type of contraceptive. Please discuss this with your doctor.

Taking other medicines with Elleste Duet Conti Tablets

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including over-the-counter medicines.

In particular, tell your doctor if you are using any of the following because they may alter the effects of Elleste Duet Conti Tablets:

drugs that treat epilepsy, some anti-infectives (anti-virals or antibiotics) and sedatives. herbal medicines containing St. John's Wort: diabetic drugs, as this product may affect your blood glucose level. If you are being treated for diabetes please let your doctor or pharmacist know that you take Elleste Duet Conti.

If your doctor does not know that you are taking these other medicines, tell him or her before you start taking Elleste Duet Conti Tablets.

Pregnancy and breast-feeding

Elleste Duet Conti Tablets are for use in post-menopausal women. They should not be taken by pregnant or breast-feeding women.

Driving or using machines

No effects on driving or using machinery have been observed for Elleste Duet Conti Tablets.

Important information about some of the ingredients of Elleste Duet Conti Tablets

Elleste Duet Conti Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Elleste Duet Conti Tablets If you are not taking any HRT

If you are not taking any HRT, you can start taking Elleste Duet Conti Tablets straightaway.

Take one tablet each day. You can take the tablets at a time of the day that suits you, but it is best to take them at about the same time each day. Swallow the tablets whole, with some water. All the tablets are the same. The days are marked on the strip to help you to remember to take one each day. Follow the direction of the arrows on the pack and take a tablet every day until the pack is empty. When you finish a foil strip, start a new strip the next day. Changing from another type of HRT

If you are changing from another type of HRT, and you usually have a monthly bleed, start taking Elleste Duet Conti Tablets on the first day of bleeding.

If you do not have a monthly bleed, start taking Elleste Duet Conti Tablets on any convenient day.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

Will I have periods?

You should not have monthly periods. In the first few months you may get some breakthrough bleeding or spotting. As you continue to take Elleste Duet Conti Tablets, some women will continue to have light spotting and some women will not bleed at all.

Tell your doctor if you:

still getting some bleeding after the first 3 to 4 months and this is a problem for you; don't bleed for a long time, but then start bleeding again. If you forget to take a tablet

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. You may experience some breakthrough bleeding or spotting.

If you take more than you should

There should be no problems, but you may feel sick or actually be sick. If you are worried, contact your doctor. Take the usual tablet the following day.

Possible Side Effects

Like all medicines, Elleste Duet Conti Tablets can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Stop taking the tablets immediately and tell your doctor if: you become jaundiced (your skin or the whites of your eyes look yellow); you have itching all over your body; you have an unusual, severe or prolonged headache; your sight is affected in any way; you find it difficult to speak; any part of your body suddenly feels weak or numb; there is a chance that you could be or could become pregnant; or you develop any of the conditions listed under "Before you take Elleste Duet Conti Tablets".

During the first few months you may feel sick, have headaches, or your breasts may be painful or increase in size. These side effects should lessen as your body gets used to the medicine.

You may also get the following side effects:

Common: feeling sick, stomach cramps, headache, an increase in size of fibroids in the womb, breakthrough bleeding, changes in weight, oedema (swelling) of legs, breast tenderness and enlargement, mood changes, changes in sex drive.

Uncommon: indigestion, being sick, flatulence, gallstones and gallbladder disease, feeling dizzy, migraine, vaginal thrush, increase in blood pressure, leg cramps, breast cancer (please refer to the earlier section on breast cancer).

Rare: loss of hair from the scalp, increase in body and facial hair, itchiness, rashes, thromboembolic disease (please refer to the earlier section on the effects of HRT on the heart and circulation).

Very rare: heart disease (please refer to the earlier section on the effects of HRT on the heart and circulation), stroke, chloasma (brown patches on the skin), red swellings on the skin.

HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.

How To Store Elleste Duet Conti Tablets

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not take Elleste Duet Conti Tablets after the 'expiry date' shown on the box.

If your tablets are out of date, take them to your pharmacist who will dispose of them safely.

Further Information What Elleste Duet Conti Tablets contains Each tablet contains the active ingredients: 2 milligrams estradiol (as hemihydrate) and 1 milligram norethisterone acetate.
(The estradiol used to make Elleste Duet Conti Tablets does not come from animals). The tablets also contain: lactose monohydrate, maize starch, povidone, talc, magnesium stearate, macrogol 400, titanium dioxide (E171), black iron oxide (E172), and hypromellose (E464) (see also the warning at the end of section 2). What Elleste Duet Conti Tablets look like and contents of the pack

Elleste Duet Conti Tablets are grey film-coated tablets with an embossing.

They are supplied in three blister strips in each pack. Each strip contains 28 tablets.

Marketing Authorisation Holder Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Piramal Healthcare UK Ltd. Whalton Road Morpeth Northumberland NE61 3YA UK

This leaflet was last approved in October 2009.

If you have any comments on the way this leaflet is written, please write to

Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK

20701188

5029/PIL8


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Nolvadex


tamoxifen citrate
Dosage Form: tablets
BOXED WARNING

For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with Nolvadex in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY-Clinical Studies ? Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for Nolvadex vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for Nolvadex vs 0.04 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for Nolvadex vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for Nolvadex versus 0.25 for placebo**.

Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering Nolvadex to reduce their risk of developing breast cancer.

The benefits of Nolvadex outweigh its risks in women already diagnosed with breast cancer.

*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.

**See Table 3 under CLINICAL PHARMACOLOGY-Clinical Studies

Nolvadex Description

Nolvadex® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. Nolvadex Tablets are available as:

10 mg Tablets:

Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.

20 mg Tablets:

Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen.

Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch.

Chemically, Nolvadex is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are:

Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.

Nolvadex - Clinical Pharmacology

Nolvadex is a nonsteroidal agent that has demonstrated potent antiestrogenic properties in animal test systems. The antiestrogenic effects may be related to its ability to compete with estrogen for binding sites in target tissues such as breast. Tamoxifen inhibits the induction of rat mammary carcinoma induced by dimethylbenzanthracene (DMBA) and causes the regression of already established DMBA-induced tumors. In this rat model, tamoxifen appears to exert its antitumor effects by binding the estrogen receptors.

In cytosols derived from human breast adenocarcinomas, tamoxifen competes with estradiol for estrogen receptor protein.

Absorption and Distribution:

Following a single oral dose of 20 mg tamoxifen, an average peak plasma concentration of 40 ng/mL (range 35 to 45 ng/mL) occurred approximately 5 hours after dosing. The decline in plasma concentrations of tamoxifen is biphasic with a terminal elimination half-life of about 5 to 7 days. The average peak plasma concentration of N-desmethyl tamoxifen is 15 ng/mL (range 10 to 20 ng/mL). Chronic administration of 10 mg tamoxifen given twice daily for 3 months to patients results in average steady-state plasma concentrations of 120 ng/mL (range 67-183 ng/mL) for tamoxifen and 336 ng/mL (range 148-654 ng/mL) for N-desmethyl tamoxifen. The average steady-state plasma concentrations of tamoxifen and N-desmethyl tamoxifen after administration of 20 mg tamoxifen once daily for 3 months are 122 ng/mL (range 71-183 ng/mL) and 353 ng/mL (range 152-706 ng/mL), respectively. After initiation of therapy, steady state concentrations for tamoxifen are achieved in about 4 weeks and steady-state concentrations for N-desmethyl tamoxifen are achieved in about 8 weeks, suggesting a half-life of approximately 14 days for this metabolite. In a steady-state, crossover study of 10 mg Nolvadex tablets given twice a day vs. a 20 mg Nolvadex tablet given once daily, the 20 mg Nolvadex tablet was bioequivalent to the 10 mg Nolvadex tablets.

Metabolism:

Tamoxifen is extensively metabolized after oral administration. N-desmethyl tamoxifen is the major metabolite found in patients' plasma. The biological activity of N-desmethyl tamoxifen appears to be similar to that of tamoxifen. 4-Hydroxytamoxifen and a side chain primary alcohol derivative of tamoxifen have been identified as minor metabolites in plasma. Tamoxifen is a substrate of cytochrome P-450 3A, 2C9 and 2D6, and an inhibitor of P-glycoprotein.

Excretion:

Studies in women receiving 20 mg of 14C tamoxifen have shown that approximately 65% of the administered dose was excreted from the body over a period of 2 weeks with fecal excretion as the primary route of elimination. The drug is excreted mainly as polar conjugates, with unchanged drug and unconjugated metabolites accounting for less than 30% of the total fecal radioactivity.

Special Populations:

The effects of age, gender and race on the pharmacokinetics of tamoxifen have not been determined. The effects of reduced liver function on the metabolism and pharmacokinetics of tamoxifen have not been determined.

Pediatric Patients:

The pharmacokinetics of tamoxifen and N-desmethyl tamoxifen were characterized using a population pharmacokinetic analysis with sparse samples per patient obtained from 27 female pediatric patients aged 2 to 10 years enrolled in a study designed to evaluate the safety, efficacy, and pharmacokinetics of Nolvadex in treating McCune-Albright Syndrome. Rich data from two tamoxifen citrate pharmacokinetic trials in which 59 postmenopausal women with breast cancer completed the studies were included in the analysis to determine the structural pharmacokinetic model for tamoxifen. A one-compartment model provided the best fit to the data.

In pediatric patients, an average steady state peak plasma concentration (Css, max) and AUC were of 187 ng/mL and 4110 ng hr/mL, respectively, and Css, max occurred approximately 8 hours after dosing. Clearance (CL/F) as body weight adjusted in female pediatric patients was approximately 2.3-fold higher than in female breast cancer patients. In the youngest cohort of female pediatric patients (2-6 year olds), CL/F was 2.6-fold higher; in the oldest cohort (7-10.9 year olds) CL/F was approximately 1.9-fold higher. Exposure to N-desmethyl tamoxifen was comparable between the pediatric and adult patients. The safety and efficacy of Nolvadex for girls aged two to 10 years with McCune-Albright Syndrome and precocious puberty have not been studied beyond one year of treatment. The long-term effects of Nolvadex therapy in girls have not been established. In adults treated with Nolvadex an increase in incidence of uterine malignancies, stroke and pulmonary embolism has been noted (see BOXED WARNING).

Drug-Drug Interactions:

In vitro studies showed that erythromycin, cyclosporin, nifedipine and diltiazem competitively inhibited formation of N-desmethyl tamoxifen with apparent K1 of 20, 1, 45 and 30 µM, respectively. The clinical significance of these in vitro studies is unknown.

Tamoxifen reduced the plasma concentration of letrozole by 37% when these drugs were co-administered. Rifampin, a cytochrome P-450 3A4 inducer reduced tamoxifen AUC and Cmax by 86% and 55%, respectively. Aminoglutethimide reduces tamoxifen and N-desmethyl tamoxifen plasma concentrations. Medroxyprogesterone reduces plasma concentrations of N-desmethyl, but not tamoxifen.

In the anastrozole adjuvant trial, co-administration of anastrozole and Nolvadex in breast cancer patients reduced anastrozole plasma concentration by 27% compared to those achieved with anastrozole alone; however, the coadministration did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen (see PRECAUTIONS -Drug Interactions). Nolvadex should not be co-administered with anastrozole.

Clinical Studies Metastatic Breast Cancer: Premenopausal Women (Nolvadex vs. Ablation):

Three prospective, randomized studies (Ingle, Pritchard, Buchanan) compared Nolvadex to ovarian ablation (oophorectomy or ovarian irradiation) in premenopausal women with advanced breast cancer. Although the objective response rate, time to treatment failure, and survival were similar with both treatments, the limited patient accrual prevented a demonstration of equivalence. In an overview analysis of survival data from the 3 studies, the hazard ratio for death (Nolvadex/ovarian ablation) was 1.00 with two-sided 95% confidence intervals of 0.73 to 1.37. Elevated serum and plasma estrogens have been observed in premenopausal women receiving Nolvadex, but the data from the randomized studies do not suggest an adverse effect of this increase. A limited number of premenopausal patients with disease progression during Nolvadex therapy responded to subsequent ovarian ablation.

Male Breast Cancer:

Published results from 122 patients (119 evaluable) and case reports in 16 patients (13 evaluable) treated with Nolvadex have shown that Nolvadex is effective for the palliative treatment of male breast cancer. Sixty-six of these 132 evaluable patients responded to Nolvadex which constitutes a 50% objective response rate.

Adjuvant Breast Cancer: Overview:

The Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) conducted worldwide overviews of systemic adjuvant therapy for early breast cancer in 1985, 1990, and again in 1995. In 1998, 10-year outcome data were reported for 36,689 women in 55 randomized trials of adjuvant Nolvadex using doses of 20-40 mg/day for 1-5+ years. Twenty-five percent of patients received 1 year or less of trial treatment, 52% received 2 years, and 23% received about 5 years. Forty-eight percent of tumors were estrogen receptor (ER) positive (> 10 fmol/mg), 21% were ER poor (< 10 fmol/l), and 31% were ER unknown. Among 29,441 patients with ER positive or unknown breast cancer, 58% were entered into trials comparing Nolvadex to no adjuvant therapy and 42% were entered into trials comparing Nolvadex in combination with chemotherapy vs. the same chemotherapy alone. Among these patients, 54% had node positive disease and 46% had node negative disease.

Among women with ER positive or unknown breast cancer and positive nodes who received about 5 years of treatment, overall survival at 10 years was 61.4% for Nolvadex vs. 50.5% for control (logrank 2p < 0.00001). The recurrence-free rate at 10 years was 59.7% for Nolvadex vs. 44.5% for control (logrank 2p < 0.00001). Among women with ER positive or unknown breast cancer and negative nodes who received about 5 years of treatment, overall survival at 10 years was 78.9% for Nolvadex vs. 73.3% for control (logrank 2p < 0.00001). The recurrence-free rate at 10 years was 79.2% for Nolvadex versus 64.3% for control (logrank 2p < 0.00001).

The effect of the scheduled duration of tamoxifen may be described as follows. In women with ER positive or unknown breast cancer receiving 1 year or less, 2 years or about 5 years of Nolvadex, the proportional reductions in mortality were 12%, 17% and 26%, respectively (trend significant at 2p < 0.003). The corresponding reductions in breast cancer recurrence were 21%, 29% and 47% (trend significant at 2p < 0.00001).

Benefit is less clear for women with ER poor breast cancer in whom the proportional reduction in recurrence was 10% (2p = 0.007) for all durations taken together, or 9% (2p = 0.02) if contralateral breast cancers are excluded. The corresponding reduction in mortality was 6% (NS). The effects of about 5 years of Nolvadex on recurrence and mortality were similar regardless of age and concurrent chemotherapy. There was no indication that doses greater than 20 mg per day were more effective.

Anastrozole Adjuvant ATAC Trial Study of Anastrozole compared to Nolvadex for Adjuvant Treatment of Early Breast Cancer:

An anastrozole adjuvant trial was conducted in 9366 postmenopausal women with operable breast cancer who were randomized to receive adjuvant treatment with either anastrozole 1 mg daily, Nolvadex 20 mg daily, or a combination of these two treatments for five years or until recurrence of the disease. At a median follow-up of 33 months, the combination of anastrozole and Nolvadex did not demonstrate any efficacy benefit when compared with Nolvadex therapy alone, in all patients as well as in the hormone receptor-positive subpopulation. This treatment arm was discontinued from the trial. Please refer to CLINICAL PHARMACOLOGY-Special Populations-Drug-Drug Interactions, PRECAUTIONS-Laboratory Tests, PRECAUTIONS-Drug Interactions and ADVERSE REACTIONS sections for safety information from this trial. Please refer to the full prescribing information for ARIMIDEX® (anastrozole) 1 mg Tablets for additional information on this trial.

Patients in the two monotherapy arms of the ATAC trial were treated for a median of 60 months (5 years) and followed for a median of 68 months. Disease-free survival in the intent-to-treat population was statistically significantly improved [Hazard Ratio (HR) = 0.87, 95% CI: 0.78, 0.97, p=0.0127] in the anatrozole arm compared to the Nolvadex arm.

Node Positive - Individual Studies:

Two studies (Hubay and NSABP B-09) demonstrated an improved disease-free survival following radical or modified radical mastectomy in postmenopausal women or women 50 years of age or older with surgically curable breast cancer with positive axillary nodes when Nolvadex was added to adjuvant cytotoxic chemotherapy. In the Hubay study, Nolvadex was added to "low-dose" CMF (cyclophosphamide, methotrexate and fluorouracil). In the NSABP B-09 study, Nolvadex was added to melphalan [L-phenylalanine mustard (P)] and fluorouracil (F).

In the Hubay study, patients with a positive (more than 3 fmol) estrogen receptor were more likely to benefit. In the NSABP B-09 study in women age 50-59 years, only women with both estrogen and progesterone receptor levels 10 fmol or greater clearly benefited, while there was a nonstatistically significant trend toward adverse effect in women with both estrogen and progesterone receptor levels less than 10 fmol. In women age 60-70 years, there was a trend toward a beneficial effect of Nolvadex without any clear relationship to estrogen or progesterone receptor status.

Three prospective studies (ECOG-1178, Toronto, NATO) using Nolvadex adjuvantly as a single agent demonstrated an improved disease-free survival following total mastectomy and axillary dissection for postmenopausal women with positive axillary nodes compared to placebo/no treatment controls. The NATO study also demonstrated an overall survival benefit.

Node Negative - Individual Studies:

NSABP B-14, a prospective, double-blind, randomized study, compared Nolvadex to placebo in women with axillary node-negative, estrogen-receptor positive (?10 fmol/mg cytosol protein) breast cancer (as adjuvant therapy, following total mastectomy and axillary dissection, or segmental resection, axillary dissection, and breast radiation). After five years of treatment, there was a significant improvement in disease-free survival in women receiving Nolvadex. This benefit was apparent both in women under age 50 and in women at or beyond age 50.

One additional randomized study (NATO) demonstrated improved disease-free survival for Nolvadex compared to no adjuvant therapy following total mastectomy and axillary dissection in postmenopausal women with axillary node-negative breast cancer. In this study, the benefits of Nolvadex appeared to be independent of estrogen receptor status.

Duration of Therapy:

In the EBCTCG 1995 overview, the reduction in recurrence and mortality was greater in those studies that used tamoxifen for about 5 years than in those that used tamoxifen for a shorter period of therapy.

In the NSABP B-14 trial, in which patients were randomized to Nolvadex 20 mg/day for 5 years vs. placebo and were disease-free at the end of this 5-year period were offered rerandomization to an additional 5 years of Nolvadex or placebo. With 4 years of follow-up after this rerandomization, 92% of the women that received 5 years of Nolvadex were alive and disease-free, compared to 86% of the women scheduled to receive 10 years of Nolvadex (p=0.003). Overall survivals were 96% and 94%, respectively (p=0.08). Results of the B-14 study suggest that continuation of therapy beyond 5 years does not provide additional benefit.

A Scottish trial of 5 years of tamoxifen vs. indefinite treatment found a disease-free survival of 70% in the five-year group and 61% in the indefinite group, with 6.2 years median follow-up (HR=1.27, 95% CI 0.87-1.85).

In a large randomized trial conducted by the Swedish Breast Cancer Cooperative Group of adjuvant Nolvadex 40 mg/day for 2 or 5 years, overall survival at 10 years was estimated to be 80% in the patients in the 5-year tamoxifen group, compared with 74% among corresponding patients in the 2-year treatment group (p=0.03). Disease-free survival at 10 years was 73% in the 5-year group and 67% in the 2-year group (p=0.009). Compared with 2 years of tamoxifen treatment, 5 years of treatment resulted in a slightly greater reduction in the incidence of contralateral breast cancer at 10 years, but this difference was not statistically significant.

Contralateral Breast Cancer:

The incidence of contralateral breast cancer is reduced in breast cancer patients (premenopausal and postmenopausal) receiving Nolvadex compared to placebo. Data on contralateral breast cancer are available from 32,422 out of 36,689 patients in the 1995 overview analysis of the Early Breast Cancer Trialists Collaborative Group (EBCTCG). In clinical trials with Nolvadex of 1 year or less, 2 years, and about 5 years duration, the proportional reductions in the incidence rate of contralateral breast cancer among women receiving Nolvadex were 13% (NS), 26% (2p = 0.004) and 47% (2p < 0.00001), with a significant trend favoring longer tamoxifen duration (2p = 0.008). The proportional reductions in the incidence of contralateral breast cancer were independent of age and ER status of the primary tumor. Treatment with about 5 years of Nolvadex reduced the annual incidence rate of contralateral breast cancer from 7.6 per 1,000 patients in the control group compared with 3.9 per 1,000 patients in the tamoxifen group.

In a large randomized trial in Sweden (the Stockholm Trial) of adjuvant Nolvadex 40 mg/day for 2-5 years, the incidence of second primary breast tumors was reduced 40% (p < 0.008) on tamoxifen compared to control. In the NSABP B-14 trial in which patients were randomized to Nolvadex 20 mg/day for 5 years vs. placebo, the incidence of second primary breast cancers was also significantly reduced (p < 0.01). In NSABP B-14, the annual rate of contralateral breast cancer was 8.0 per 1000 patients in the placebo group compared with 5.0 per 1,000 patients in the tamoxifen group, at 10 years after first randomization.

Ductal Carcinoma in Situ:

NSABP B-24, a double-blind, randomized trial included women with ductal carcinoma in situ (DCIS). This trial compared the addition of Nolvadex or placebo to treatment with lumpectomy and radiation therapy for women with DCIS. The primary objective was to determine whether 5 years of Nolvadex therapy (20 mg/day) would reduce the incidence of invasive breast cancer in the ipsilateral (the same) or contralateral (the opposite) breast.

In this trial 1,804 women were randomized to receive either Nolvadex or placebo for 5 years: 902 women were randomized to Nolvadex 10 mg tablets twice a day and 902 women were randomized to placebo. As of December 31, 1998, follow-up data were available for 1,798 women and the median duration of follow-up was 74 months.

The Nolvadex and placebo groups were well balanced for baseline demographic and prognostic factors. Over 80% of the tumors were less than or equal to 1 cm in their maximum dimension, were not palpable, and were detected by mammography alone. Over 60% of the study population was postmenopausal. In 16% of patients, the margin of the resected specimen was reported as being positive after surgery. Approximately half of the tumors were reported to contain comedo necrosis.

For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to Nolvadex (44 cases - Nolvadex, 74 cases - placebo; p=0.004; relative risk (RR)=0.57, 95% CI: 0.39-0.84). No data are available regarding the ER status of the invasive cancers. The stage distribution of the invasive cancers at diagnosis was similar to that reported annually in the SEER data base.

Results are shown in Table 1. For each endpoint the following results are presented: the number of events and rate per 1,000 women per year for the placebo and Nolvadex groups; and the relative risk (RR) and its associated 95% confidence interval (CI) between Nolvadex and placebo. Relative risks less than 1.0 indicate a benefit of Nolvadex therapy. The limits of the confidence intervals can be used to assess the statistical significance of the benefits of Nolvadex therapy. If the upper limit of the CI is less than 1.0, then a statistically significant benefit exists.

Table 1Major Outcomes of the NSABP B-24 Trial

Type of Event

Lumpectomy, radiotherapy and placebo

Lumpectomy, radiotherapy, and Nolvadex

RR

95% CI Limits

No. of events

Rate per 1000 women per year

No. of events

Rate per 1000 women per year

* Updated follow-up data (median 8.1 years)

Invasive breast cancer (Primary endpoint)

74

16.73

44

9.60

0.57

0.39 to 0.84

-Ipsilateral

47

10.61

27

5.90

0.56

0.33 to 0.91

-Contralateral

25

5.64

17

3.71

0.66

0.33 to 1.27

-Side undetermined

2

--

0

--

--

Secondary Endpoints

DCIS

56

12.66

41

8.95

0.71

0.46 to 1.08

-Ipsilateral

46

10.40

38

8.29

0.88

0.51 to 1.25

-Contralateral

10

2.26

3

0.65

0.29

0.05 to 1.13

All Breast Cancer Events

129

29.16

84

18.34

0.63

0.47 to 0.83

-All ipsilateral events

96

21.70

65

14.19

0.65

0.47 to 0.91

-All contralateral events

37

8.36

20

4.37

0.52

0.29 to 0.92

Deaths

32

28

Uterine Malignancies*

4

9

Endometrial Adenocarcinoma*

4

0.57

8

1.15

Uterine Sarcoma*

0

0.0

1

0.14

Second primary malignancies (other than endometrial and breast)

30

29

Stroke

2

7

Thromboembolic events (DVT, PE)

5

15

Survival was similar in the placebo and Nolvadex groups. At 5 years from study entry, survival was 97% for both groups.

Reduction in Breast Cancer Incidence in High Risk Women:

The Breast Cancer Prevention Trial (BCPT, NSABP P-1) was a double-blind, randomized, placebo-controlled trial with a primary objective to determine whether 5 years of Nolvadex therapy (20 mg/day) would reduce the incidence of invasive breast cancer in women at high risk for the disease (See INDICATIONS AND USAGE). Secondary objectives included an evaluation of the incidence of ischemic heart disease; the effects on the incidence of bone fractures; and other events that might be associated with the use of Nolvadex, including: endometrial cancer, pulmonary embolus, deep vein thrombosis, stroke, and cataract formation and surgery (See WARNINGS).

The Gail Model was used to calculate predicted breast cancer risk for women who were less than 60 years of age and did not have lobular carcinoma in situ (LCIS). The following risk factors were used: age; number of first-degree female relatives with breast cancer; previous breast biopsies; presence or absence of atypical hyperplasia; nulliparity; age at first live birth; and age at menarche. A 5-year predicted risk of breast cancer of ? 1.67% was required for entry into the trial.

In this trial, 13,388 women of at least 35 years of age were randomized to receive either Nolvadex or placebo for five years. The median duration of treatment was 3.5 years. As of January 31, 1998, follow-up data is available for 13,114 women. Twenty-seven percent of women randomized to placebo (1,782) and 24% of women randomized to Nolvadex (1,596) completed 5 years of therapy. The demographic characteristics of women on the trial with follow-up data are shown in Table 2.

Table 2Demographic Characteristics of Women in the NSABP P-1 Trial

Characteristic

Placebo

Tamoxifen

#

%

#

%

Age (yrs)

35-39

184

3

158

2

40-49

2,394

36

2,411

37

50-59

2,011

31

2,019

31

60-69

1,588

24

1,563

24

?70

393

6

393

6

Age at first live birth (yrs.)

Nulliparous

1,202

18

1,205

18

12-19

915

14

946

15

20-24

2,448

37

2,449

37

25-29

1,399

21

1,367

21

?30

606

9

577

9

Race

White

6,333

96

6,323

96

Black

109

2

103

2

Other

128

2

118

2

Age at menarche

?14

1,243

19

1,170

18

12-13

3,610

55

3,610

55

?11

1,717

26

1,764

27

# of first degree relatives with breast cancer

0

1,584

24

1,525

23

1

3,714

57

3,744

57

2+

1,272

19

1,275

20

Prior Hysterectomy

No

4,173

63.5

4,018

62.4

Yes

2,397

36.5

2,464

37.7

# of previous breast biopsies

0

2,935

45

2,923

45

1

1,833

28

1,850

28

?2

1,802

27

1,771

27

History of atypical hyperplasia in the breast

No

5,958

91

5,969

91

Yes

612

9

575

9

History of LCIS at entry

No

6,165

94

6,135

94

Yes

405

6

409

6

5-year predicated breast cancer risk (%)

?2.00

1,646

25

1,626

25

2.01-3.00

2,028

31

2,057

31

3.01-5.00

1,787

27

1,707

26

?5.01

1,109

17

1,162

18

Total

6,570

100.0

6,544

100.0

Results are shown in Table 3. After a median follow-up of 4.2 years, the incidence of invasive breast cancer was reduced by 44% among women assigned to Nolvadex (86 cases-Nolvadex, 156 cases-placebo; p<0.00001; relative risk (RR)=0.56, 95% CI: 0.43-0.72). A reduction in the incidence of breast cancer was seen in each prospectively specified age group (? 49, 50-59, ? 60), in women with or without LCIS, and in each of the absolute risk levels specified in Table 3. A non-significant decrease in the incidence of ductal carcinoma in situ (DCIS) was seen (23-Nolvadex, 35-placebo; RR=0.66; 95% CI: 0.39-1.11).

There was no statistically significant difference in the number of myocardial infarctions, severe angina, or acute ischemic cardiac events between the two groups (61-Nolvadex, 59-placebo; RR=1.04, 95% CI: 0.73-1.49).

No overall difference in mortality (53 deaths in Nolvadex group vs. 65 deaths in placebo group) was present. No difference in breast cancer-related mortality was observed (4 deaths in Nolvadex group vs. 5 deaths in placebo group).

Although there was a non-significant reduction in the number of hip fractures (9 on Nolvadex, 20 on placebo) in the Nolvadex group, the number of wrist fractures was similar in the two treatment groups (69 on Nolvadex, 74 on placebo). A subgroup analysis of the P-1 trial, suggests a difference in effect in bone mineral density (BMD) related to menopausal status in patients receiving Nolvadex. In postmenopausal women there was no evidence of bone loss of the lumbar spine and hip. Conversely, Nolvadex was associated with significant bone loss of the lumbar spine and hip in premenopausal women.

The risks of Nolvadex therapy include endometrial cancer, DVT, PE, stroke, cataract formation and cataract surgery (See Table 3). In the NSABP P-1 trial, 33 cases of endometrial cancer were observed in the Nolvadex group vs. 14 in the placebo group (RR=2.48, 95% CI: 1.27-4.92). Deep vein thrombosis was observed in 30 women receiving Nolvadex vs. 19 in women receiving placebo (RR=1.59, 95% CI: 0.86-2.98). Eighteen cases of pulmonary embolism were observed in the Nolvadex group vs. 6 in the placebo group (RR=3.01, 95% CI: 1.15-9.27). There were 34 strokes on the Nolvadex arm and 24 on the placebo arm (RR=1.42; 95% CI: 0.82-2.51). Cataract formation in women without cataracts at baseline was observed in 540 women taking Nolvadex vs. 483 women receiving placebo (RR=1.13, 95% CI: 1.00-1.28). Cataract surgery (with or without cataracts at baseline) was performed in 201 women taking Nolvadex vs. 129 women receiving placebo (RR=1.51, 95% CI: 1.21-1.89) (See WARNINGS).

Table 3 summarizes the major outcomes of the NSABP P-1 trial. For each endpoint, the following results are presented: the number of events and rate per 1000 women per year for the placebo and Nolvadex groups; and the relative risk (RR) and its associated 95% confidence interval (CI) between Nolvadex and placebo. Relative risks less than 1.0 indicate a benefit of Nolvadex therapy. The limits of the confidence intervals can be used to assess the statistical significance of the benefits or risks of Nolvadex therapy. If the upper limit of the CI is less than 1.0, then a statistically significant benefit exists.

For most participants, multiple risk factors would have been required for eligibility. This table considers risk factors individually, regardless of other co-existing risk factors, for women who developed breast cancer. The 5-year predicted absolute breast cancer risk accounts for multiple risk factors in an individual and should provide the best estimate of individual benefit (See INDICATIONS AND USAGE).

Table 3Major Outcomes of the NSABP P-1 Trial

# of Events

Rate/1000 Women/Year

95% CI

Type of Event

Placebo

Nolvadex

Placebo

Nolvadex


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Xenical 120mg hard capsules


1. Name Of The Medicinal Product

Xenical 120 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 120 mg orlistat.

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Hard capsule.

The capsule has a turquoise cap and turquoise body bearing the imprint of “ROCHE XENICAL 120”.

4. Clinical Particulars 4.1 Therapeutic Indications

Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m?, or overweight patients (BMI > 28 kg/m?) with associated risk factors.

Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.

4.2 Posology And Method Of Administration

Adults

The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.

The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.

Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.

The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.

Special populations

The effect of orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied.

There is no relevant indication for use of Xenical in children.

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients.

- Chronic malabsorption syndrome.

- Cholestasis.

- Breast-feeding.

4.4 Special Warnings And Precautions For Use

In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients. Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.

Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).

Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).

The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g. in a 2000 kcal/day diet,> 30 % of calories from fat equates to> 67 g of fat). The daily intake of fat should be distributed over three main meals. If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.

Cases of rectal bleeding have been reported with Xenical. Prescribers should investigate further in case of severe and/or persistent symptoms.

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).

Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants (see section 4.5 and 4.8).

The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patients with underlying chronic kidney disease and/or volume depletion (see section 4.8).

Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.5).

Antiepileptics patient: Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ciclosporin

A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly. This can lead to a decrease of immunosuppressive efficacy. Therefore the combination is not recommended (see section 4.4). However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients. Ciclosporin blood levels should be monitored until stabilised.

Acarbose

In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.

Oral anticoagulants

When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).

Fat soluble vitamins

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).

The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range. In order to ensure adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered. If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of orlistat or at bedtime.

Amiodarone

A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly. In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases. In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted.

Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. Therefore, these patients should be monitored for possible changes in the frequency and/or severity of convulsions.

Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.4).

Lack of interactions

No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed. The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.

The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies. However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases. An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).

4.6 Pregnancy And Lactation

For orlistat no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

Caution should be exercised when prescribing to pregnant women.

As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Xenical has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse reactions to orlistat are largely gastrointestinal in nature. The incidence of adverse events decreased with prolonged use of orlistat.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of> 2 % and with an incidence

System organ class

Adverse reaction/event

Nervous system disorders

 

Very common:

Headache

Respiratory, thoracic and mediastinal disorders

 

Very common:

Upper respiratory infection

Common:

Lower respiratory infection

Gastrointestinal disorders

 

Very common:

Abdominal pain/discomfort

Oily spotting from the rectum

Flatus with discharge

Faecal urgency

Fatty/oily stool

Flatulence

Liquid stools

Oily evacuation

Increased defecation

Common:

Rectal pain/discomfort

Soft stools

Faecal incontinence

Abdominal distension*

Tooth disorder

Gingival disorder

Renal and urinary disorders

 

Common:

Urinary tract infection

Metabolism and nutrition disorders

 

Very common:

Hypoglycaemia*

Infections and infestations

 

Very common:

Influenza

General disorders and administration site conditions

 

Common:

Fatigue

Reproductive system and breast disorders

 

Common:

Menstrual irregularity

Psychiatric disorders

 

Common:

Anxiety

* only unique treatment adverse events that occurred at a frequency of> 2 % and with an incidence

In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.

The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:

System organ class

Adverse reaction

Investigations

 

Increase in liver transaminases and in alkaline phosphatase.

Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)

Gastrointestinal disorders

 

Rectal bleeding

Diverticulitis

Pancreatitis

Skin and subcutaneous tissue disorders

Bullous eruptions

Immune system disorders

Hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis)

Hepatobiliary disorders

Cholelithiasis

Hepatitis that may be serious

Renal and urinary disorders

Oxalate nephropathy

4.9 Overdose

Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg tid have been administered to obese patients for 6 months. The majority of orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.

Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group: Peripherally acting antiobesity agent, ATC code A08AB01.

Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides.

In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.

Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37 % of orlistat patients and 19 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment. Of these, 49 % of orlistat treated patients and 40 % of placebo treated patients went on to lose

Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment. Of these, 62 % of orlistat treated patients and 52 % of placebo treated patients went on to lose

More patients on orlistat or placebo lost baseline body weight of at least 5 % at 12 weeks or 10 % at one year in the XENDOS study than in the five 2-year studies. The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.

Data from the 4-year clinical trial also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative diabetes cases incidences: 3.4 % in the orlistat group compared to 5.4 % in the placebo-treated group). The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21 % of the randomised patients. It is not known whether these findings translate into long-term clinical benefits.

In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four one-year clinical trials showed that the percentage of responders (

In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks. Both populations received multivitamin supplements. The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.

The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/m2 in favour of orlistat). 9.5 % of the orlistat treated patients versus 3.3 % of the placebo treated patients lost

5.2 Pharmacokinetic Properties

Absorption

Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal. Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.

In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.

Distribution

The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics. In vitro orlistat is> 99 % bound to plasma proteins (lipoproteins and albumin were the major binding proteins). Orlistat minimally partitions into erythrocytes.

Metabolism

Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall. Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.

M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively). In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml respectively), these metabolites are considered to be pharmacologically inconsequential.

Elimination

Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination. Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.

The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose. The time to reach complete excretion (faecal plus urinary) was 3 to 5 days. The disposition of orlistat appeared to be similar between normal weight and obese volunteers. Orlistat, M1 and M3 are all subject to biliary excretion.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.

In animal reproductive studies, no teratogenic effect was observed. In the absence of a teratogenic effect in animals, no malformative effect is expected in man. To date, active substances responsible for malformations in man have been found teratogenic in animals when well-conducted studies were performed in two species.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Capsule filling:

microcrystalline cellulose (E460)

sodium starch glycollate

povidone (E1201)

sodium lauryl sulphate

talc

Capsule shell:

gelatine

indigo carmine (E132)

titanium dioxide (E171)

edible printing ink (black iron oxide, ammonium hydroxide, potassium hydroxide, shellac)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Blisters: Do not store above 25 °C. Store in original package in order to protect from moisture.

Bottles: Do not store above 30 °C. Keep the container tightly closed in order to protect from moisture.

6.5 Nature And Contents Of Container

PVC/PE/PVDC blisters containing 21, 42 and 84 hard capsules.

Glass bottles with desiccant containing 21, 42 and 84 hard capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

8. Marketing Authorisation Number(S)

EU/1/98/071/001-006

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 29 July 1998

Date of latest renewal: 29 July 2008

10. Date Of Revision Of The Text

25 March 2009

LEGAL STATUS

POM


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Nexium Delayed-Release Capsules


Pronunciation: ES-oh-MEP-ra-zole
Generic Name: Esomeprazole
Brand Name: Nexium
Nexium Delayed-Release Capsules are used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may also be used to prevent stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It may also be used with certain antibiotics to treat ulcers of the small intestines and to prevent them from coming back. It may also be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Nexium Delayed-Release Capsules are a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.

Do NOT use Nexium Delayed-Release Capsules if: you are allergic to any ingredient in Nexium Delayed-Release Capsules or to any similar medicine (eg, omeprazole) you are taking dasatinib, certain HIV protease inhibitors (eg, atazanavir, nelfinavir), rifampin, or St. John's wort.

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nexium Delayed-Release Capsules:

Some medical conditions may interact with Nexium Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood potassium or magnesium levels, liver problems or stomach or bowel cancer if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Nexium Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased Voriconazole because it may increase the risk of Nexium Delayed-Release Capsules's side effects Ginkgo biloba, rifampin, or St. John's wort because they may decrease Nexium Delayed-Release Capsules's effectiveness Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, or saquinavir because the risk of their side effects may be increased by Nexium Delayed-Release Capsules Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir, nelfinavir), iron, mycophenolate, or tyrosine kinase inhibitors (eg, dasatinib, erlotinib) because their effectiveness may be decreased by Nexium Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexium Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nexium Delayed-Release Capsules:

Use Nexium Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Nexium Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information. Take Nexium Delayed-Release Capsules by mouth on an empty stomach at least 1 hour before eating. Swallow Nexium Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you have difficulty swallowing the capsule, you may add 1 tablespoon of applesauce to an empty bowl. Open the capsule and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the mixture right away. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets. Do not store the mixture for future use. You may take antacids while you are using Nexium Delayed-Release Capsules if you are directed to do so by your doctor. Continue to take Nexium Delayed-Release Capsules even if you feel well. Do not miss any doses. If you miss a dose of Nexium Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nexium Delayed-Release Capsules.

Important safety information: Nexium Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nexium Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. Nexium Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Nexium Delayed-Release Capsules in high doses, for longer than a year, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Nexium Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Nexium Delayed-Release Capsules. Nexium Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Nexium Delayed-Release Capsules. Use Nexium Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures. Caution is advised when using Nexium Delayed-Release Capsules in CHILDREN; they may be more likely to experience drowsiness from Nexium Delayed-Release Capsules. Nexium Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nexium Delayed-Release Capsules while you are pregnant. It is not known if Nexium Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Nexium Delayed-Release Capsules. Possible side effects of Nexium Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever or chills; persistent sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nexium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; fast heartbeat; flushing; increased sweating; severe headache, drowsiness, or nausea.

Proper storage of Nexium Delayed-Release Capsules:

Store Nexium Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nexium Delayed-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Nexium Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Nexium Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nexium Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Nexium resources Nexium Side Effects (in more detail) Nexium Use in Pregnancy & Breastfeeding Drug Images Nexium Drug Interactions Nexium Support Group 52 Reviews for Nexium - Add your own review/rating Compare Nexium with other medications Barrett's Esophagus Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Helicobacter Pylori Infection NSAID-Induced Gastric Ulcer Pathological Hypersecretory Conditions Zollinger-Ellison Syndrome
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Fluarix


Pronunciation: IN-floo-EN-za
Generic Name: Influenza Virus Vaccine
Brand Name: Fluarix
Fluarix is used for:

Protecting against certain strains of influenza (flu).

Fluarix is a vaccine. It works by stimulating the body to produce antibodies against certain types of the flu virus, which helps your body to fight the infection.

Do NOT use Fluarix if: you are allergic to any ingredient in Fluarix, including eggs or egg products you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a prior flu vaccination

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluarix:

Some medical conditions may interact with Fluarix. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (including rubber or latex) if you have a fever, cold, respiratory tract infection, or other infection or recent illness if you have asthma or other breathing problems, a nervous system disorder, or blood or bleeding problems (eg, hemophilia, low blood platelet levels) if you have cancer or immune system problems (eg, HIV, weakened immune system) if you are receiving radiation treatment or chemotherapy if you have a history of Guillain-Barr?© syndrome

Some MEDICINES MAY INTERACT with Fluarix. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased Corticosteroids (eg, prednisone) or other medicines that may weaken the immune system because they may decrease Fluarix's effectiveness. Ask your doctor if you are unsure if any of your medicines may weaken the immune system Phenytoin or theophylline because the risk of their side effects may be increased by Fluarix

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluarix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluarix:

Use Fluarix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Fluarix is usually given once a year in September, October, or November. Fluarix is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions. Do not use Fluarix if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. If you miss a dose of Fluarix, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluarix.

Important safety information: If you have a fever, cold, respiratory tract infection, or other illness, contact your doctor before you receive Fluarix. You may need to receive your injection at a later time. Fluarix is not a cure for the flu. It must be given before you are exposed to the flu in order to be effective. Fluarix contains killed viruses. It cannot cause you to develop the flu. Fluarix is only effective for 1 flu season. You will need to receive the flu vaccine each year. Fluarix is not effective against all strains of the flu virus. It may also not protect everyone who receives it. Fluarix does not protect against other respiratory viruses. Tell your doctor if you will be receiving any other vaccines. Tell your doctor or dentist that you have used Fluarix before you receive any medical or dental care, emergency care, or surgery. Use Fluarix with caution in the ELDERLY; its effectiveness may be decreased in elderly patients. Fluarix should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluarix while you are pregnant. It is not known if Fluarix is found in breast milk. If you are or will be breast-feeding while you use Fluarix, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Fluarix:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; drowsiness; fatigue; general body discomfort; headache; irritability; loss of appetite; mild fever; mild pain, redness, swelling, or tenderness at the injection site; muscle aches.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache or fever; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fluarix side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fluarix:

Fluarix is usually handled and stored by a health care provider. If you are using Fluarix at home, store Fluarix as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information: If you have any questions about Fluarix, please talk with your doctor, pharmacist, or other health care provider. Fluarix is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fluarix. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Fluarix resources Fluarix Side Effects (in more detail) Fluarix Use in Pregnancy & Breastfeeding Fluarix Drug Interactions Fluarix Support Group 0 Reviews for Fluarix - Add your own review/rating Fluarix Prescribing Information (FDA) Fluarix Consumer Overview Fluarix Advanced Consumer (Micromedex) - Includes Dosage Information Afluria Prescribing Information (FDA) Afluria Consumer Overview Agriflu Consumer Overview FluLaval Consumer Overview Flulaval Prescribing Information (FDA) Fluvirin Prescribing Information (FDA) Fluzone Prescribing Information (FDA) Influenza Virus Vaccine Inactivated Monograph (AHFS DI) Influenza Virus Vaccine Live Intranasal Monograph (AHFS DI) Compare Fluarix with other medications Influenza Prophylaxis
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Cyclo-Progynova 2mg


Cyclo-Progynova 2 mg

Please read this leaflet carefully before you start to take your medicine. This leaflet provides a summary of the information known about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Remember this medicine is for you. Only a doctor can prescribe this medicine and it may harm someone else, even if their symptoms are the same as yours.

About your medicine What is your medicine?

The name of your medicine is Cyclo-Progynova 2 mg.

Each strip of Cyclo-Progynova 2 mg has 11 white tablets containing 2 mg estradiol valerate and 10 pale brown tablets each containing 2 mg estradiol valerate and 500 micrograms of norgestrel.

The active ingredient in this medicine is estradiol. This is the new name for oestradiol. The ingredient itself has not changed.

Cyclo-Progynova 2 mg also contains the following inactive ingredients: lactose, maize starch, povidone, magnesium stearate (E 572), sucrose, polyethylene glycol 6000, calcium carbonate (E 170), glycerin (E 422), talc, montan glycol wax, titanium dioxide (E 171), yellow and red/brown ferric oxide pigments (E 172).

Each pack of Cyclo-Progynova 2 mg contains 1 or 3 memo-packs (strips) of 21 tablets.

Who produces your medicine The product licence is held by: MEDA Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop’s Stortford CM22 6PU This product is manufactured by: Bayer Schering Pharma AG D-13342 Berlin GERMANY What your medicine does and what it is used for

Cyclo-Progynova 2 mg is a hormone replacement therapy that contains the female sex hormones oestrogen and progestogen.

These hormones are lost in women during the "change of life" (also known as "the climacteric"). This is a gradual process which usually takes place between the ages of about 45 and 55. Periods usually become irregular, both in timing and amount of blood loss, before they stop altogether, but the time at which the periods finally stop - "the menopause" – is not the end of the change of life, which always continues for some time afterwards.

Although the change of life is natural, it often causes distressing symptoms such as hot flushes. These symptoms are due to the gradual loss of the female sex hormones produced by the ovaries.

Cyclo-Progynova 2 mg is used to treat symptoms associated with "the change of life".

In addition, the loss of these hormones may, in some women, lead to thinning of the bones (osteoporosis) in later life. If you are likely to develop osteoporosis, and are unable to take other medicines which can prevent osteoporosis, you may be prescribed Cyclo-Progynova 2 mg to prevent osteoporosis. Your doctor will be able to advise you further.

Cyclo-Progynova 2 mg will not make you able to have children, but on the other hand Cyclo-Progynova 2 mg will not prevent you becoming pregnant if you are still fertile.

Before taking your medicine You must not take Cyclo-Progynova 2 mg If you have, or have had, cancer of the breast If you have, or have had, cancer of the or womb If you currently have any problems with your liver If you have vaginal bleeding and the cause is not known If you have a condition called endometrial hyperplasia (where the lining of the womb grows more than normal) and if you are not having treatment for it If you have a blood clot in a vein in your leg or anywhere else (a "deep vein thrombosis") or if you have had one of these in the past If you have a blood clot that has travelled to your lung or another part of the body (an "embolus") or if you have had one of these in the past If you have, or have had, a disease related to blood clots such as angina, or a heart attack If you are allergic to any of the ingredients in Cyclo-Progynova If you have the condition known as porphyria. If you are pregnant, suspect that you are pregnant or if you are breast feeding What you should know before using Cyclo-Progynova

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Medical Check-ups

Before starting to take hormone replacement therapy you should discuss your personal and family medical history with your doctor.

Your doctor may decide to perform a physical examination of the breasts and/or a pelvic examination before starting this medication - but only if these examinations are necessary for you, or if you have any special concerns.

Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Before starting to take your medicine you must tell your doctor if you have, or have had any of the following as he may decide to alter your treatment or he may ask to see you more often:-

fibroids in your uterus endometriosis (when the lining of the womb grows outside the womb) a family history of cancer of the breast or womb liver disease diabetes gall stones migraine or severe headaches a condition known as systemic lupus erythematosus a condition called endometrial hyperplasia (where the lining of the womb grows more than normal) epilepsy asthma deafness (otosclerosis) hypertension risk factors that indicate you may experience blood clots. These include being seriously overweight, having blood clotting problems or having a blood clot previously. The full list of these risk factors is provided in the section on Blood clotting below.

Be sure to:

go for regular breast screening and cervical smear tests regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.

Effects On Your Heart or Circulation

Heart Disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication.

For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get: a pain in your chest that spreads to your arm or neck you must see a doctor as soon as possible. Do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Consider the following:

Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get unexplained migraine-type headaches (with or without disturbed vision) you must see a doctor as soon as possible. Do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood Clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Consider the following:

Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get any of the following:

painful swelling in your leg sudden chest pain difficulty breathing

you must see a doctor as soon as possible. Do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on Your Risk of Developing Cancer

Breast Cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT. Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight

Consider the following:

Looking at women aged 50 who are not taking HRT – on average 32 in 1000 will have breast cancer diagnosed by the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (ie an extra 1-2 cases). If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases). If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).

If you notice any changes in your breast, such as:

dimpling of the skin changes in the nipple any lumps you can see or feel

you must make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the oestrogen helps to lower the extra risk.

If you still have your womb, your doctor may prescribe a progestogen as well as oestrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. If so, your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.

Your product, Cyclo-Progynova 2 mg contains a progestogen.

Consider the following:

Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take oestrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it.

The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

carries on for more than the first few months starts after you’ve been on HRT for a while carries on even after you’ve stopped taking HRT

you must make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious.

It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

What about other medicines that you may be taking?

Some medicines affect the way that drugs are handled by the liver and may reduce the effectiveness of Cyclo-Progynova 2 mg. These include some epilepsy medicines (for example phenytoin, phenobarbital and carbamazepine), and some antibiotics/anti-infectives (for example rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir) and the herbal preparation, St John’s Wort.

If you are taking oral contraceptives, these should be stopped and other, non-hormonal methods of contraception should be used.

If you are a diabetic on insulin or tablets, your daily dose might need to be changed, your doctor will advise you.

What about food and drink?

Cyclo-Progynova 2 mg is not known to react with any types of food and drink.

What to do if you see a different doctor or have to go to hospital for treatment.

If you see any other doctor or go to hospital for treatment, tell your doctor about all your medicines, including Cyclo-Progynova 2 mg.

Special warnings

Lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

You should stop taking your tablets and tell your doctor if you:

develop any of the conditions listed in this leaflet under "You must not take Cyclo-Progynova". start developing headaches or migraines develop jaundice or problems with your liver become pregnant experience pain, tingling or numbness in any part of the body experience sudden chest pain

Cyclo-Progynova 2 mg must also be stopped at once if your doctor finds your blood pressure to be significantly raised.

Taking your medicine How to take your Cyclo-Progynova 2 mg

It is usually recommended that Cyclo-Progynova is taken at the lowest dose which is effective and for the shortest time possible.

About the pack:

The pack of Cyclo-Progynova 2 mg is designed to help you take your tablets. To use it you must first know the day of the week on which you will take the first tablet. If you are still having your periods, take the first tablet on the fifth day of your period, whether the period has finished or not. If your periods have become infrequent or have stopped altogether, your doctor may have advised you to start Cyclo-Progynova 2 mg immediately. If you have been taking a continuous HRT product (i.e. you take the same dose each day) you may change to Cyclo-Progynova 2 mg on any day. If you have been taking an HRT product which is followed by a withdrawal bleed, you should complete the cycle of treatment before changing to Cyclo-Progynova 2 mg.

In addition to the memo-pack (which contains the tablets), the outer carton contains a self adhesive blue sticker showing the days of the week. Peel the circular sticker off its backing and stick it in the centre of the memo-pack so that the day on which you start taking the tablets is directly underneath the red segment marked 'Start'.

For instance, if you are to start the tablets on a Wednesday, then stick a 'Wed' directly underneath the red segment marked 'Start'. You can now see on which day you have to take each tablet. Simply take one tablet each day, following the direction of the arrows on the foil, until the pack is empty. This means that you will be taking one white tablet for the first 11 days and then one pale brown tablet daily for the following 10 days. If, at any time, you are in doubt whether you have taken your tablet, a glance at the appropriate day on the memo-pack will tell you.

When you have finished taking your pack, you must leave a tablet free interval of seven days (unless your doctor decides otherwise). During this week, bleeding similar to a period may occur. This is normal.

Start your next pack of Cyclo-Progynova 2 mg immediately after this seven day break, whether the bleeding has stopped or not. You will in fact start on the same day of the week that you started your previous pack and the same will be true for each successive pack.

It is best to take your tablet at the same time each day, preferably after a meal. The tablet should not be chewed or sucked, but swallowed whole with a glass of water.

What to do if you forget to take a tablet

Take it as soon as possible, and take the next one at your normal time. If you are more than twelve hours late, leave the forgotten tablet in the pack. Continue to take the remaining tablets at the usual time on the right days.

You may experience some vaginal bleeding (breakthrough bleeding) if you have missed a tablet. This is normal.

What to do if you take too many tablets at once

There have been no reports of ill effects from taking too many tablets.

You should consult your doctor who will be able to advise you what action, if any, is necessary.

What bleeding to expect (what to do if your bleeding pattern seems different)

Just as with normal periods, the amount of bleeding with Cyclo-Progynova 2 mg varies from woman to woman. Usually the blood loss is not unduly heavy and it may even be rather scanty, but this is not important as far as the treatment is concerned. If you have recently had very light, short periods, you may have rather heavier blood loss with Cyclo-Progynova 2 mg.

If you are still menstruating, you will probably have regular blood loss 2 – 3 days after finishing each pack of Cyclo-Progynova 2 mg. If you miss a period, the possibility of pregnancy should be investigated.

Ask your doctor for advice.

If you have stopped having periods, Cyclo-Progynova 2 mg will probably cause you to experience blood loss again after the end of each pack, but may not always do so.

If blood loss occurs during the three weeks in which you are taking the tablets, let your doctor know. This may be a sign that your endometrium is getting thicker (see section on Endometrial Cancer in this leaflet). It is not necessary to stop taking your tablets unless your doctor tells you to.

After taking your medicine

During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting) and some breast tenderness or enlargement. These symptoms are usually temporary and normally disappear with continued treatment. If they don't, contact your doctor.

All women have a small chance of having a blood clot in the veins of the leg, in the lung or other parts of the body whether or not they take HRT. If you think you have developed a blood clot while you are taking Cyclo-Progynova 2 mg you should stop taking it immediately and contact your doctor. The warning signs to look out for are listed in this leaflet in the section on Blood Clots under What you should know before taking Cyclo-Progynova.

The following symptoms have been reported: indigestion, nausea, vomiting, bloated stomach, increased appetite, increased or reduced weight, leg pains, fluid retention, palpitations, dizziness, anxiety, headaches, depressive moods, rashes, altered sexual interest. Tell your doctor if you have any of these symptoms, or, indeed, any other symptoms while you are taking Cyclo-Progynova 2 mg.

If you have any of the symptoms of heart disease, stroke or blood clots, breast, endometrial or ovarian cancer, as described earlier in this leaflet, tell your doctor.

Dementia: HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.

How to store your medicine

Keep your medicine in a safe place where children cannot see or reach it. Your medicine could harm them.

Do not use your medicines after the expiry date on the box, even if there is some medicine left after this date. Ask your doctor for a replacement prescription.

This leaflet was amended in November 2007

Cyclo-Progynova is a registered trademark of Schering AG.

© MEDA

United Kingdom 80620633_1107


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