Toctino 10mg and 30mg soft capsules.


Toctino alitretinoin

Toctino 10 mg soft capsules

Toctino 30 mg soft capsules

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further 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 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 Toctino is and what it is used for 2 Before you take Toctino 3 How to take Toctino 4 Possible side effects 5 How to store Toctino 6 Further information What Toctino is and what it is used for

The active substance in Toctino is alitretinoin. It belongs to a group of medicines known as retinoids which are related to Vitamin A. Toctino capsules come in two strengths, containing 10 mg or 30 mg of alitretinoin.

Toctino is used for patients with severe chronic hand eczema that has not got better after any other topical treatments, including steroids. Treatment with Toctino must be supervised by a specialist skin doctor (a dermatologist).

Before you take Toctino Do not take Toctino: If you are pregnant or if you can become pregnant and are not using effective birth control measures (see below, 'Pregnancy and breast-feeding') If you are breast-feeding If you have liver disease If you have severe kidney disease If you have high blood fats (such as high cholesterol or raised triglycerides) If you have untreated thyroid disease If you have very high levels of vitamin A in your body (hypervitaminosis A) If you are allergic (hypersensitive) to alitretinoin, to other retinoids (such as isotretinoin) or any of the other ingredients of Toctino (they are listed in section 6). If you are taking tetracycline (a type of antibiotic).

If any of these apply to you, go back to your doctor.
You must not take Toctino.

Your doctor needs to know before treatment: If you have ever had any mental health problems, including depression, suicidal behaviour or psychosis, or if you take medicines for any of these conditions. If you have high blood fats, you may need blood tests more often. Toctino commonly increases blood fats, such as cholesterol or triglycerides. If your blood fats stay high, your doctor may lower your dose, or take you off Toctino. If you have been suffering from thyroid disease.
Toctino may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements. You need to take care during treatment: If you experience any problems with your sight, tell your doctor immediately. Toctino may need to be stopped and your sight monitored. If you get a persistent headache, nausea or vomiting (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension.
Stop the capsules immediately and contact your doctor as soon as possible. If you have bloody diarrhoea stop the capsules immediately and contact your doctor as soon as possible. Minimise your exposure to sunlight and avoid sun lamps. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher). Cut down on intensive physical exercise: alitretinoin can cause muscle and joint pain. If you develop dry eyes, lubricating eye ointment or tear replacement drops can help. If you wear contact lenses, you may need to wear glasses during alitretinoin treatment. Dry eyes and sight problems normally return to normal once treatment is stopped. Taking other medicines

Do not take vitamin A supplements or tetracyclines (a type of antibiotic) while taking Toctino. This increases the risk of side effects.

Tell your doctor or a pharmacist if you are taking other medicines or have recently taken any. This includes medicines obtained without a prescription, and herbal medicines such as St. John's Wort.

! Pregnancy and breast-feeding

Important advice for women

Do not take Toctino if you are breast-feeding

The medicine is likely to pass into your milk and may harm your baby.

Do not take Toctino if you are pregnant

Toctino is likely to cause severe birth defects (in medical language it is teratogenic). It also increases the risk of miscarriage.

You must not take Toctino when you are pregnant. You must not get pregnant during treatment with Toctino, or during the month after treatment.

If you are a woman and could get pregnant:

You must not use Toctino because of the risk of birth defects (damage to the unborn baby), unless you meet the following STRICT rules:

Your doctor must have explained the risk of birth defects: you understand why you must not get pregnant and what you need to do to prevent it. You must have discussed contraception (birth control) with your doctor. They will give you information on preventing pregnancy. He or she may refer you to a specialist for contraceptive advice. You must agree to use one or preferably two effective methods of contraception, including condoms or a cap plus spermicide, for a month before taking Toctino, during treatment and for a month afterwards. Before you start treatment your doctor will ask you to take a pregnancy test, which must be negative. You must use contraception even if you do not have periods or are not currently sexually active unless your doctor decides that there is absolutely no risk of pregnancy (for example because your womb has been removed). You must agree to monthly visits and more pregnancy tests during treatment and around 5 weeks after stopping treatment, as decided by your doctor. These tests should be performed in the first 3 days of the menstrual cycle.
You must not get pregnant during treatment or for a month afterwards. Your doctor may ask you (or a guardian) to sign a form that confirms that you have been told about the risks, and that you accept the necessary precautions.

Prescriptions for women who could get pregnant are for no more than 30 days treatment.

A new prescription is needed for more treatment.

Each prescription is only valid for 7 days.

If you do get pregnant while taking Toctino, or in the month after treatment has stopped, stop taking the medicine straight away, and contact your doctor. He or she may refer you to a specialist for advice.

Your doctor will show you written information on pregnancy and contraception for the users of Toctino.
If you haven't seen this material already, ask your doctor for it.

Advice for men

Very low amounts of alitretinoin are present in the semen of men taking Toctino, but too little to harm the unborn baby of your partner. You must remember not to share your medication with anyone, particularly not women.

Advice for both sexes

Do not donate blood while you are taking Toctino or for one month afterwards. If someone who is pregnant is given your blood, the baby may be born with birth defects.

Driving and using machines

You may not see as well at night during your treatment. If this happens to you, you should not drive or operate machinery.

Important information about some of the ingredients of Toctino

Toctino contains soya bean oil and sorbitol. If you are allergic to peanut or soya, do not use this medicinal product. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Toctino.

How to take Toctino When to take the capsules

The capsule should be taken with a meal. The capsules should be swallowed whole and not chewed.

How much to take

The dose will be between 10 mg and 30 mg once daily. If your body can't tolerate the recommended dose, you may be prescribed a lower dose. Always take Toctino exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How long should you take the capsules

A course of treatment usually lasts for 12 to 24 weeks depending how your disease gets better. If your first treatment was successful, your doctor may prescribe another course of treatment if symptoms return.

If you take more than you should

If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.

If you forget to take a capsule

If you miss a dose take it as soon as you can. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten capsule.

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

Possible side effects

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

Very common effects

(these may affect more than 1 in every 10 people):

Headache Raised blood fats: higher levels of fats (triglycerides) and cholesterol in the blood Common effects

(may affect up to 1 in every 10 people):

Blood cell disorders: decreased clotting, decrease in the number of red and white blood cells seen in blood tests Thyroid problems: decreased levels of thyroid hormones Eye problems: inflammation of the eye (conjunctivitis) and eyelid area; eyes feel dry and irritated.

Ask a pharmacist for suitable eye drops. If you wear contact lenses and get dry eyes, you may need to wear glasses instead

Blood and circulation: flushing Muscle and joint pain: back pain, muscle pain, joint pain. High levels of muscle breakdown products in your blood if you exercise vigorously. Skin and hair problems: dryness of the skin, especially of the lips and face, inflamed skin, hair loss Liver problems: raised liver enzymes seen in blood tests. Uncommon effects

(may affect up to 1 in every 100 people):

Sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).

If your sight is affected, stop taking Toctino immediately and contact your doctor.

Skin problems: hair loss, skin peeling, rash, dry skin eczema Ear, nose and throat problems: nose bleeding Bone disorders: extra growth of bone, including the spine disorder ankylosing spondylitis. Rare effects

(may affect up to 1 in every 1000 people):

Lasting headache, along with feeling sick (nausea), being sick (vomiting) and changes in your eyesight including blurred vision. These may be signs of benign intracranial hypertension.

If you experience these symptoms, stop taking Toctino immediately and contact your doctor.

Blood and circulation: inflammation of blood vessels. Side effects of other medicines in the same family as Toctino

These effects haven't been seen in Toctino so far, but they can't be ruled out. They are very rare and may affect up to 1 in every 10,000 people.

Depression and other mental problems. Depression, including sad or empty mood, mood changes, tearfulness and emotional disorder. Some people have had thoughts about harming themselves or ending their lives, have attempted suicide or committed suicide. These people may not appear to be depressed.

Contact your doctor immediately if you get signs of any of these mental problems. Your doctor may tell you to stop taking Toctino. That may not be enough to stop the effects: you may need more help, and your doctor can arrange this

Gut and stomach disorders. Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting).

Stop taking Toctino immediately and contact your doctor. These can be signs of serious gut conditions

Diabetes. Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar. These can all be signs of diabetes. Bone disorders. Arthritis; bone disorders (delayed growth, changes to bone density); growing bones may stop growing. Visual disorders. You may see less well at night; colour blindness and colour vision gets worse.

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Toctino

Keep out of the reach and sight of children.

Do not use Toctino after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Keep the blister in the outer carton to protect from light.

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 Toctino contains

Each soft capsule contains 10 mg or 30 mg of alitretinoin.

The capsules also contain: Soya bean oil (refined), partially hydrogenated soya bean oil, medium chain triglycerides, yellow beeswax, all-rac-?-tocopherol

The capsule shell consists of: gelatin, glycerol, sorbitol liquid (non-crystallising), water purified, iron oxide (E172).

What Toctino looks like and contents of the pack

Toctino comes in soft capsules. The capsules are oval, opaque, coloured brown or red-brown. The capsules come in blister packs of 30.

Marketing Authorisation Holder Basilea Medical Ltd 14/16 Frederick Sanger Road The Surrey Research Park Guildford Surrey GU2 7YD Tel.:+44(0)1483 790020

10 mg: PL 32205/0001
30 mg: PL 32205/0002

Manufacturer Swiss Caps GmbH Grassingerstr. 9 83043 Bad Aibling Germany

This leaflet was last approved in 08/2008.

400002

11002733


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Acute Alcohol Intoxication Medications


There are currently no drugs listed for "Acute Alcohol Intoxication".

Learn more about Acute Alcohol Intoxication

Micromedex Care Notes:

Alcohol Dependence And Withdrawal Alcohol Intoxication

Medical Encyclopedia:

Alcoholism and alcohol abuse
Drug List:
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Alcoholic Psychosis Medications


There are currently no drugs listed for "Alcoholic Psychosis".

Learn more about Alcoholic Psychosis

Micromedex Care Notes:

Acute Delirium Alcohol Dependence And Withdrawal Alcohol Intoxication Alcohol Withdrawal Brief Psychotic Disorder

Medical Encyclopedia:

Alcohol withdrawal Alcoholism and alcohol abuse
Drug List:
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Alcohol Hepatitis Medications


There are currently no drugs listed for "Alcohol Hepatitis".

Learn more about Alcohol Hepatitis

Medical Encyclopedia:

Alcoholic liver disease
Drug List:
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Isopropyl Alcohol



MWI 99% Isopropyl Alcohol quart MWI 99% Isopropyl Alcohol quart

CONTAINS:

Active Ingredients:

   Isopropyl Alcohol .........................99%

Inert Ingredients:

   Water ...............................................1%

INDICATIONS: Widely used by veterinarians and artificial inseminators as a bactericide and antiseptic.
May also be used for temporary relief of minor muscular aches or pains caused by overexerction or fatigue. For use in manufacturing, processing or repacking. 

DIRECTIONS FOR USE: Dilute with water as desired. Scrub hands and arms with soap and water. Rinse with water and then scrub with alcohol. As a rub-down, apply full-strength directly to the affected area. Wet thoroughly and massage briskly to stimulate circulation.

MWI 99% Isopropyl Alcohol quart

WARNING: Flammable Liquid

For External Use Only

STORAGE: Store at controlled room temperature between 10 and 30 C(50 - 85F). Keep away from heat and open flame. Keep container closed when not in use.

MADE IN USA         TAKE TIME          OBSERVE LABEL DIRECTIONS

Distributed by:
MWI
Meridian, ID 83680
(888) 694-8381
www.vetone.net

MWI 99% Isopropyl Alcohol quart jug213332 innercase213332 outercase213332


Isopropyl Alcohol 
Isopropyl Alcohol  liquid Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 13985-330 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl Alcohol (Isopropyl Alcohol) Isopropyl Alcohol 99 L  in 100 L Inactive Ingredients Ingredient Name Strength WATER 1 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 13985-330-91 4 BOX In 1 CASE contains a BOX (13985-330-90) 1 13985-330-90 4 JUG In 1 BOX This package is contained within the CASE (13985-330-91) and contains a JUG (13985-330-89) 1 13985-330-89 0.946 L In 1 JUG This package is contained within a BOX (13985-330-90) and a CASE (13985-330-91)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2010
Labeler - MWI/Vet One (019926120) Revised: 05/2010MWI/Vet One

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Sterets H Pre-Injection Swabs (Molnlycke Health Care )


1. Name Of The Medicinal Product

Sterets H Pre-Injection Swabs.

2. Qualitative And Quantitative Composition

Isopropyl Alcohol BP 70% v/v; Chlorhexidine Acetate BP 0.5% w/v.

3. Pharmaceutical Form

Sachets containing viscose swab impregnated with isopropyl alcohol and chlorhexidine acetate.

4. Clinical Particulars 4.1 Therapeutic Indications

To be used for pre-injection site cleansing.

4.2 Posology And Method Of Administration

Topical. There are no differences in use between adults, the elderly and children. Use the wipe to cleanse the injection site.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes or broken skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol should not be brought into contact with some vaccines and skin test injections (patch tests). If in doubt, consult the vaccine manufacturers' literature.

4.6 Pregnancy And Lactation

No special precautions required.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Normally without side effects although minor skin reactions have been attributed to chlorhexidine and to isopropyl alcohol (infrequent, minor).

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Isopropyl alcohol has disinfectant properties. Chlorhexidine is a disinfectant that is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria. A 0.5% solution of chlorhexidine acetate in 70% isopropyl alcohol is used for pre-operative disinfection of the skin. The solution is appropriate for swabbing on to cleanse and lower the skin bacteriological count prior to injections.

5.2 Pharmacokinetic Properties

There is little absorption of isopropyl alcohol through intact skin. Chlorhexidine acetate is adsorbed on to the skin surface but there is minimal further absorption. Pharmacokinetic particulars are not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

60 months unopened.

6.4 Special Precautions For Storage

Store in a cool dry place, away from direct sunlight. Flammable contents. Flash point 24oC. Product/contents should be kept away from a naked flame.

6.5 Nature And Contents Of Container

100 sachets per box. Printed aluminium foil laminated sachets (laminates of coated paper/polyethylene/aluminium foil/surlyn, the surlyn layer innermost).

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS, UK.

8. Marketing Authorisation Number(S)

21248/0026.

9. Date Of First Authorisation/Renewal Of The Authorisation

3rd February 2006.

10. Date Of Revision Of The Text

February 2006.


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Boots Antifungal Cream


Boots Antifungal Cream

(Clotrimazole)

for fungal infections of the skin

20 g

Read all of this carton for full instructions.

What this medicine is for

An antifungal cream for the treatment of fungal skin infections including ringworm, athlete’s foot, fungal nappy rash, infections of the armpit, groin, toes and skin folds and thrush of the vulva or penis.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Information about some of the ingredients: The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using this medicine in the genital area. You may, for example, use a spermicide gel in addition to the condom or diaphragm. If you need more advice about this speak to your pharmacist.

Cetyl alcohol and stearyl alcohol in this medicine may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream.

Pierce tube seal with end of cap.

Adults and children: Apply to the affected area two or three times a day. Use the cream for at least 2 weeks. In some cases it may be necessary to continue to use the cream for more than 4 weeks.

If you are using the cream for a foot infection, make sure your feet, especially between the toes, are washed and thoroughly dried before applying the cream. Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects, stop using the cream and see a doctor: Allergic reaction (e.g. skin rash, red or itchy skin) These other effects are less serious. If they bother you talk to a pharmacist: Rarely, mild burning or irritation immediately after using the cream Pain

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This topical cream contains Clotrimazole 1% w/w.

Also contains: purified water, 2-octyldodecanol, stearyl alcohol, cetyl alcohol, cetyl esters wax, sorbitan stearate, polysorbate 60, benzyl alcohol.

PL 10622/0004 [P]

Text prepared 8/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

Thornton & Ross Ltd Linthwaite Huddersfield West Yorkshire HD7 5QH Marketing Authorisation held by PLIVA Pharma Ltd Vision House Bedford Road Petersfield Hampshire GU32 2QB

If you need more advice ask your pharmacist.

1498cXPil


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Boots Lip and Cold Sore Cream


Boots Lip and Cold Sore Cream

Relieves cracked lips and cold sores

5 g

Read all of this carton for full instructions.

What this medicine is for

An antibacterial and protective cream for cracked lips and cold sores.

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Adults and children: Use a very small amount on the affected area every hour, when you need to.

Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor.

Possible side effects

Cetostearyl alcohol may cause skin reactions (e.g. contact dermatitis).

If this becomes severe, or you notice any side effect, please tell your pharmacist or doctor.

How to store this medicine

Store below 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

This cream contains Cetrimide 0.5% w/w, Chlorocresol 0.1% w/w, Dimeticone 9% w/w, Urea 1% w/w.

Also contains: deionised water, liquid paraffin, cetostearyl alcohol.

PL 30306/0028

Text prepared 8/07

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

CCS Clean Chemicals Sweden AB Borl?nge SE 78173 Sweden Marketing Authorisation held by Actavis Group PTC ehf Reykjv?kurvegi 76 – 78 220 Hafnarfjorur Iceland

If you need more advice ask your pharmacist .

2787bXPil


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Covonia Catarrh Relief Formula


1. Name Of The Medicinal Product

Covonia Catarrh Relief Formula

2. Qualitative And Quantitative Composition

Each 5ml contains:-

Liquid Extract Boneset (1:1 21% alcohol) 0.6ml

Liquid Extract Blue Flag (1:1 37% alcohol) 0.05ml

Liquid Extract Burdock Root (1:1 21% alcohol) 0.25ml

Liquid Extract Hyssop (1:1 21% alcohol) 0.35ml

3. Pharmaceutical Form

Oral Liquid

4. Clinical Particulars 4.1 Therapeutic Indications

A herbal remedy traditionally used for the symptomatic relief of nasal catarrh and catarrh of the throat.

4.2 Posology And Method Of Administration

Adults and the Elderly (only): One 5ml spoonful three times a day.

Children over 12: One 5ml spoonful morning and evening

Children under 12: Not recommended

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

This medicinal product contains 11.5 vol% ethanol (alcohol), i.e. up to 453 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Patients with rare glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Refer to 4.4

4.6 Pregnancy And Lactation

There are no adequate data from the use of Covonia Catarrh Relief Formula in pregnant women. Covonia Catarrh Relief Formula should not be used in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

None

4.9 Overdose

No cases known.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Boneset and Hyssop are specific herbal anticatarrhals. Boneset is also immune-stimulant.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

No information available.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chloroform spirit (containing chloroform, ethanol and purified water), methyl parahydroxybenzoate (E218), tincture capsicum (containing capsicum oleoresin, ethanol and water), colour solution (containing nipagen m, caramel (E150), glycerol (E422), chloroform, water), viscarin SD 389 (contains dextrose/carageenan (E407)), menthol, sodium saccharin (E954), and purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years unopened.

Once opened use within 28 days.

6.4 Special Precautions For Storage

Do not store above 25 degrees C.

6.5 Nature And Contents Of Container

100ml amber glass sirop bottle with 28mm polypropylene white tamper-evident cap with EPE/Aluminium/Melinex liner.

150ml amber glass bottle embossed “Covonia” with a 28mm polypropylene white tamper evident cap with EPE/Aluminium/Melinex liner.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite, Huddersfield

West Yorkshire HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0142

9. Date Of First Authorisation/Renewal Of The Authorisation

22/02/2006

10. Date Of Revision Of The Text

04/10/2010


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Mycil Ointment (Reckitt Benckiser Healthcare (UK) Ltd)


1. Name Of The Medicinal Product

Mycil Ointment.

2. Qualitative And Quantitative Composition

Tolnaftate BP 1.0% w/w

Benzalkonium Chloride Solution BP 0.2% v/w.

Excipients:

Cetostearly Alcohol

For a full list of excipients see 6.1.

3. Pharmaceutical Form

Ointment.

4. Clinical Particulars 4.1 Therapeutic Indications

For the adjunctive treatment and prevention of athlete's foot (Tinea Pedis).

It is also effective in other conditions, such as dhobie itch (Tinea Cruris) and prickly heat (Miliaria).

4.2 Posology And Method Of Administration

For topical application to the skin.

Wash and thoroughly dry the affected area before applying the ointment morning and night. Continue the treatment for at least a week after the infection has cleared up. Routine use of the ointment can help prevent infection.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

For external use only.

This product contains Cetostearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions necessary.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tonaftate is a well established drug substance having potent antifungal properties.

Benzalkonium chloride is a well established drug substance having potent anti-microbial properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arlatone 983s, cetostearyl alcohol, dimeticone 20, liquid paraffin, glycerol, purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in a cool place.

6.5 Nature And Contents Of Container

Collapsible, internally lacquered metal tube with blind end nozzle containing 25g.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0409

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 4 February 2009

10. Date Of Revision Of The Text

27/07/2011


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Acamprosate


Pronunciation: a-kam-PROE-sate
Generic Name: Acamprosate
Brand Name: Campral
Acamprosate is used for:

Treating alcohol addiction by helping certain patients to avoid alcohol. Acamprosate is used in combination with a treatment program that includes social support.

Acamprosate is an anti-alcohol agent. It is thought to work by restoring the balance of certain chemicals in the brain of patients who have used large amounts of alcohol.

Do NOT use Acamprosate if: you are allergic to any ingredient in Acamprosate you have severe kidney problems

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

Before using Acamprosate:

Some medical conditions may interact with Acamprosate. 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 or a history of depression or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Acamprosate. However, no specific interactions with Acamprosate are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acamprosate 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 Acamprosate:

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

Acamprosate may be taken with or without food. Swallow whole. Do not break, crush, or chew before swallowing. Continue to take Acamprosate even if you feel well. Do not miss any doses. If you miss a dose of Acamprosate, 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 Acamprosate.

Important safety information: Acamprosate may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acamprosate. Using Acamprosate alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Do not drink alcohol while you are using Acamprosate. Continue taking Acamprosate even if you begin drinking alcohol again. Discuss any drinking with your doctor. Alcohol-dependent patients should be monitored for the development of depression or suicidal thinking. Patients and their families or caregivers should pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood. Acamprosate will not reduce or eliminate alcohol withdrawal symptoms. Discuss any questions or concerns with your doctor. Acamprosate has been shown to help you avoid alcohol only in combination with a treatment program that includes counseling and support. Discuss treatment program options with your doctor. Use Acamprosate with caution in the ELDERLY because they may be more sensitive to its effects. Use Acamprosate with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Acamprosate during pregnancy. It is unknown if Acamprosate is excreted in breast milk. If you are or will be breast-feeding while you are using Acamprosate, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Acamprosate:

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; dizziness; gas; loss of appetite; nausea; trouble sleeping; weakness.

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); anxiety; behavior changes; depression; mental or mood changes; nervousness; panic attacks; restlessness; suicidal thoughts or behaviors.

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: Acamprosate 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 diarrhea.

Proper storage of Acamprosate:

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

General information: If you have any questions about Acamprosate, please talk with your doctor, pharmacist, or other health care provider. Acamprosate 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 Acamprosate. 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 Acamprosate resources Acamprosate Side Effects (in more detail) Acamprosate Use in Pregnancy & Breastfeeding Acamprosate Support Group 52 Reviews for Acamprosate - Add your own review/rating acamprosate Advanced Consumer (Micromedex) - Includes Dosage Information Acamprosate Calcium Monograph (AHFS DI) Campral Prescribing Information (FDA) Campral Consumer Overview Compare Acamprosate with other medications Alcohol Dependence
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Antabuse


Pronunciation: dye-SUL-fi-ram
Generic Name: Disulfiram
Brand Name: Antabuse

Antabuse must not be given to patients under the influence of alcohol or without their permission.


Antabuse is used for:

Treating alcoholism.

Antabuse is an alcohol-abuse deterrent. It works by blocking the breakdown of alcohol, causing unpleasant side effects (eg, vomiting, upset stomach) when even a small amount of alcohol is consumed.

Do NOT use Antabuse if: you are allergic to any ingredient in Antabuse or other similar medicines you are under the influence of alcohol you have severe heart disease, a blockage of your heart arteries, or a mental disorder (eg, psychosis) you are taking metronidazole or an alcohol-containing medicine (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines)

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

Before using Antabuse:

Some medical conditions may interact with Antabuse. 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 (eg, latex rubber) if you have brain damage, diabetes, heart or lung disease, mental or mood problems (eg, depression), an underactive thyroid, seizures, or liver or kidney problems

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

Alcohol-containing medicines (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines) or metronidazole because the risk of severe side effects may be increased Anticoagulants (eg, warfarin), benzodiazepines (eg, diazepam), isoniazid, or phenytoin because side effects may be increased by Antabuse

This may not be a complete list of all interactions that may occur. Ask your health care provider if Antabuse 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 Antabuse:

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

Antabuse may be taken with or without food. Antabuse may be swallowed whole, chewed, or crushed and mixed with food. Do not take the first dose of Antabuse for at least 12 hours after drinking alcohol. If you miss a dose of Antabuse, 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 Antabuse.

Important safety information: Antabuse may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Antabuse. Using Antabuse alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid all alcohol including alcohol found in sauces, vinegar, mouthwash, liquid medicines, lotions, after shave, or backrub products. A reaction to alcohol may cause flushing, nausea, thirst, abdominal pain, chest pain, dizziness, vomiting, fast breathing, fast heartbeat, fainting, difficulty breathing, or confusion. Use caution when using topical products containing alcohol, such as cologne or perfume. Before using alcohol-containing products on the skin, test the product by applying some to a small area of the skin. If no redness, itching, headache, or nausea occurs after 1 or 2 hours, you should be able to use the product. You may have a reaction if you drink alcohol or use a product that contains alcohol for 2 weeks after your last dose of Antabuse. Notify your doctor immediately if you experience yellowing of the skin or eyes, dark urine, weakness, tiredness, loss of appetite, or nausea and vomiting. These may be signs of a liver problem. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Antabuse. Carry an identification card at all times that says you are taking Antabuse. LAB TESTS, including liver function tests and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Antabuse with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Antabuse during pregnancy. It is unknown if Antabuse is excreted in breast milk. Do not breast-feed while taking Antabuse. Possible side effects of Antabuse:

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:

Drowsiness; headache; metallic or garlic taste in mouth.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in color vision; dark urine; loss of appetite; mental or mood problems; nausea; numbness or tingling of the arms or legs; seizures; tiredness; vomiting; weakness; 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: Antabuse 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 Antabuse:

Store Antabuse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Antabuse out of the reach of children and away from pets.

General information: If you have any questions about Antabuse, please talk with your doctor, pharmacist, or other health care provider. Antabuse 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 Antabuse. 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 Antabuse resources Antabuse Side Effects (in more detail) Antabuse Use in Pregnancy & Breastfeeding Drug Images Antabuse Drug Interactions Antabuse Support Group 17 Reviews for Antabuse - Add your own review/rating Antabuse Prescribing Information (FDA) Antabuse Consumer Overview Antabuse Monograph (AHFS DI) Antabuse Advanced Consumer (Micromedex) - Includes Dosage Information Disulfiram Prescribing Information (FDA) Disulfiram Professional Patient Advice (Wolters Kluwer) Compare Antabuse with other medications Alcohol Dependence
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Campral


Generic Name: acamprosate (a KAM proe sate)
Brand Names: Campral

What is acamprosate?

Acamprosate affects chemicals in the brain that may become unbalanced in a person who is addicted to alcohol. Acamprosate works by restoring this chemical balance in the brain in an alcohol-dependent person who has recently quit drinking.

Acamprosate is used to help a person who has recently quit drinking alcohol continue to choose not to drink (remain abstinent from alcohol). It is used together with behavior modification and counseling support to help you stop drinking.

Acamprosate is not likely to be helpful to a person who has not already quit drinking or undergone detoxification. It may not be helpful to a person who is also addicted to other substances besides alcohol.

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

What is the most important information I should know about acamprosate? You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

Acamprosate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many. What should I discuss with my healthcare provider before taking acamprosate? You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. It is not known whether acamprosate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acamprosate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

How should I take acamprosate?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Acamprosate treatment should be started as soon as possible after you have quit drinking.

Take this medicine with water.

Acamprosate is usually taken 3 times daily, and may be taken with or without food. If you regularly eat 3 meals per day, it may help you remember to take your acamprosate if you take a dose with each meal. Follow your doctor's instructions.

Acamprosate is only part of a complete program of treatment that also includes counseling support and continued abstinence from alcohol.

Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many.

It is important to use acamprosate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store acamprosate at room temperature away from moisture and heat.

See also: Campral dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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

Overdose can cause diarrhea but is not expected to produce serious side effects.

What should I avoid while taking acamprosate? Acamprosate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Acamprosate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effects such as:

mood or behavior changes;

thoughts about hurting yourself;

severe anxiety or depression;

feeling like you might pass out;

fast or pounding heartbeats;

swelling, weight gain, feeling short of breath;

confusion, increased thirst; or

urinating less than usual or not at all.

Less serious side effects may include:

nausea, vomiting, stomach pain, loss of appetite;

constipation, diarrhea;

headache, dizziness, drowsiness;

vision problems;

problems with memory or thinking;

weakness, cold or flu-like symptoms;

back pain, joint or muscle pain;

dry mouth, decreased or distorted sense of taste;

sleep problems (insomnia);

impotence, loss of interest in sex;

sweating, mild skin rash; or

numbness or tingly feeling.

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.

What other drugs will affect acamprosate?

There may be other drugs that can interact with acamprosate. 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 Campral resources Campral Side Effects (in more detail) Campral Dosage Campral Use in Pregnancy & Breastfeeding Drug Images Campral Support Group 51 Reviews for Campral - Add your own review/rating Campral Prescribing Information (FDA) Campral Monograph (AHFS DI) Campral Advanced Consumer (Micromedex) - Includes Dosage Information Campral MedFacts Consumer Leaflet (Wolters Kluwer) Campral Consumer Overview Compare Campral with other medications Alcohol Dependence Where can I get more information? Your pharmacist can provide more information about acamprosate.

See also: Campral side effects (in more detail)


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cyclizine


Generic Name: cyclizine (SYE kli zeen)
Brand names: Marezine, Bonine For Kids, Cyclivert

What is cyclizine?

Cyclizine is used to relieve nausea, vomiting, and dizziness associated with motion sickness.

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

What is the most important information I should know about cyclizine? Use caution when driving, operating machinery, or performing other hazardous activities. Cyclizine may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking cyclizine. Who should not take cyclizine?

Before taking this medication, tell your doctor if you have

kidney or liver disease,

an enlarged prostate,

difficulty urinating,

bladder problems, or

glaucoma.

You may not be able to take cyclizine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Cyclizine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take cyclizine without first talking to your doctor if you are pregnant. It is not known whether cyclizine passes into breast milk. Do not take cyclizine without first talking to your doctor if you are breast-feeding a baby. Cyclizine is not recommended for use by children younger than 12 years of age. How should I take cyclizine?

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

Take each dose with a full glass of water.

Cyclizine usually is taken approximately 30 minutes before travel and then every 4 to 6 hours as needed. Do not take more than 200 mg of this medication in 1 day.

Store cyclizine at room temperature away from moisture and heat.

See also: Cyclizine 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 your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a cyclizine overdose include drowsiness, agitation, excitability, seizures or convulsions, hallucinations, and death.

What should I avoid while taking cyclizine? Use caution when driving, operating machinery, or performing other hazardous activities. Cyclizine may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking cyclizine. Cyclizine side effects Stop taking cyclizine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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

drowsiness;

restlessness, excitation, nervousness, or insomnia;

blurred vision;

dry mouth, nose, or throat;

decreased appetite, nausea, or vomiting;

difficulty urinating; or

an irregular or fast heartbeat.

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. You may report side effects to FDA at 1-800-FDA-1088.

Cyclizine Dosing Information

Usual Adult Dose for Motion Sickness:

50 mg orally 30 minutes prior to departure. The dosage may be repeated every 4 to 6 hours, not to exceed 200 mg/24 hours.

Usual Adult Dose for Nausea/Vomiting:

50 mg orally or intramuscularly every 4 to 6 hours as needed.
The daily dose should not exceed 200 mg.

Usual Pediatric Dose for Motion Sickness:

13 to 18 years: 50 mg orally up to 4 times a day.
6 to 12 years: 25 mg orally up to 3 times a day.

What other drugs will affect cyclizine?

Cyclizine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

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

More cyclizine resources Cyclizine Side Effects (in more detail) Cyclizine Dosage Cyclizine Use in Pregnancy & Breastfeeding Cyclizine Drug Interactions Cyclizine Support Group 1 Review for Cyclizine - Add your own review/rating Cyclizine MedFacts Consumer Leaflet (Wolters Kluwer) Bonine for Kids MedFacts Consumer Leaflet (Wolters Kluwer) Compare cyclizine with other medications Motion Sickness Nausea/Vomiting Where can I get more information? Your pharmacist has more information about cyclizine written for health professionals that you may read.

See also: cyclizine side effects (in more detail)


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meprobamate


Generic Name: meprobamate (meh pro BA mate)
Brand names: Equanil, Miltown, MB-TAB

What is meprobamate?

Meprobamate affects chemicals in your brain that may become unbalanced and cause anxiety.

Meprobamate is used to relieve anxiety, nervousness, and tension associated with anxiety disorders.

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

What is the most important information I should know about meprobamate? Use caution when driving, operating machinery, or performing other hazardous activities. Meprobamate may cause drowsiness, dizziness, and blurred vision. If you experience drowsiness, dizziness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking meprobamate. Do not stop taking meprobamate suddenly if you have been taking it for several weeks. Stopping suddenly may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with meprobamate. Notify your doctor if you develop a fever, a skin rash, or a sore throat. What should I discuss with my healthcare provider before taking meprobamate?

Before taking this medication, tell your doctor if you have

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Treatments for depression are getting better everyday and there are things you can start doing right away.

porphyria,

kidney disease, liver disease,

epilepsy or another seizure disorder, or

a history of drug or alcohol abuse.

You may not be able to take meprobamate, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Meprobamate may harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Meprobamate passes into breast milk. Do not take meprobamate without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from meprobamate. You may require a lower dose of this medication or special monitoring during treatment. Meprobamate is not approved for use by children younger than 6 years of age. How should I take meprobamate?

Take meprobamate 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 of water. Do not crush, chew, or open any of the tablets or capsules. Swallow them whole.

Do not take more of this medication than is prescribed for you.

Do not stop taking meprobamate suddenly if you have been taking it for several weeks. Stopping suddenly may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with meprobamate. Store meprobamate at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be very dangerous.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a meprobamate overdose include sleepiness, dizziness, confusion, a slow heartbeat, difficulty breathing, difficulty walking and talking, an appearance of being drunk, and unconsciousness.

What should I avoid while taking meprobamate? Use caution when driving, operating machinery, or performing other hazardous activities. Meprobamate may cause drowsiness, dizziness, and blurred vision. If you experience drowsiness, dizziness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking meprobamate.

Avoid other sedatives, sleeping pills, and tranquilizers. They should not be used while you are taking meprobamate unless your doctor approves.

Meprobamate side effects If you experience any of the following serious side effects, stop taking meprobamate and seek emergency medical attention:

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

fast or irregular heartbeats;

abnormal behavior;

fever;

a skin rash; or

a sore throat.

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

drowsiness or dizziness,

headache,

weakness,

vomiting or diarrhea, or

numbness or tingling.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect meprobamate?

Meprobamate may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, other anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

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

More meprobamate resources Meprobamate Side Effects (in more detail) Meprobamate Use in Pregnancy & Breastfeeding Drug Images Meprobamate Drug Interactions Meprobamate Support Group 2 Reviews for Meprobamate - Add your own review/rating meprobamate Advanced Consumer (Micromedex) - Includes Dosage Information Meprobamate Prescribing Information (FDA) Meprobamate Professional Patient Advice (Wolters Kluwer) Meprobamate Monograph (AHFS DI) Meprobamate MedFacts Consumer Leaflet (Wolters Kluwer) Compare meprobamate with other medications Anxiety Where can I get more information? Your pharmacist has additional information about meprobamate written for health professionals that you may read.

See also: meprobamate side effects (in more detail)


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Equanil


Generic Name: meprobamate (meh pro BA mate)
Brand Names: Equanil, Miltown

What is Equanil (meprobamate)?

Meprobamate affects chemicals in your brain that may become unbalanced and cause anxiety.

Meprobamate is used to relieve anxiety, nervousness, and tension associated with anxiety disorders.

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

What is the most important information I should know about Equanil (meprobamate)? Use caution when driving, operating machinery, or performing other hazardous activities. Meprobamate may cause drowsiness, dizziness, and blurred vision. If you experience drowsiness, dizziness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking meprobamate. Do not stop taking meprobamate suddenly if you have been taking it for several weeks. Stopping suddenly may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with meprobamate. Notify your doctor if you develop a fever, a skin rash, or a sore throat. What should I discuss with my healthcare provider before taking Equanil (meprobamate)?

Before taking this medication, tell your doctor if you have

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

porphyria,

kidney disease, liver disease,

epilepsy or another seizure disorder, or

a history of drug or alcohol abuse.

You may not be able to take meprobamate, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Meprobamate may harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Meprobamate passes into breast milk. Do not take meprobamate without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from meprobamate. You may require a lower dose of this medication or special monitoring during treatment. Meprobamate is not approved for use by children younger than 6 years of age. How should I take Equanil (meprobamate)?

Take meprobamate 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 of water. Do not crush, chew, or open any of the tablets or capsules. Swallow them whole.

Do not take more of this medication than is prescribed for you.

Do not stop taking meprobamate suddenly if you have been taking it for several weeks. Stopping suddenly may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with meprobamate. Store meprobamate at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be very dangerous.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a meprobamate overdose include sleepiness, dizziness, confusion, a slow heartbeat, difficulty breathing, difficulty walking and talking, an appearance of being drunk, and unconsciousness.

What should I avoid while taking Equanil (meprobamate)? Use caution when driving, operating machinery, or performing other hazardous activities. Meprobamate may cause drowsiness, dizziness, and blurred vision. If you experience drowsiness, dizziness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking meprobamate.

Avoid other sedatives, sleeping pills, and tranquilizers. They should not be used while you are taking meprobamate unless your doctor approves.

Equanil (meprobamate) side effects If you experience any of the following serious side effects, stop taking meprobamate and seek emergency medical attention:

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

fast or irregular heartbeats;

abnormal behavior;

fever;

a skin rash; or

a sore throat.

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

drowsiness or dizziness,

headache,

weakness,

vomiting or diarrhea, or

numbness or tingling.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Equanil (meprobamate)?

Meprobamate may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, other anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

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

More Equanil resources Equanil Use in Pregnancy & Breastfeeding Drug Images Equanil Drug Interactions Equanil Support Group 0 Reviews for Equanil - Add your own review/rating Meprobamate Prescribing Information (FDA) Meprobamate Professional Patient Advice (Wolters Kluwer) Meprobamate Monograph (AHFS DI) Meprobamate MedFacts Consumer Leaflet (Wolters Kluwer) Mb-Tab Advanced Consumer (Micromedex) - Includes Dosage Information Compare Equanil with other medications Anxiety Where can I get more information? Your pharmacist has additional information about meprobamate written for health professionals that you may read.
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Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream


Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream

(Mepyramine Maleate)

From 2 years

Relieves pain, itching and swelling

20 g e

Read all of this carton for full instructions.

What this medicine is for

A soothing antihistamine cream for the relief of pain, itching and swelling caused by insect bites and stings, and nettle stings.

Before you use this medicine X Do not use: If you are allergic to any of the ingredients or other antihistamines If you have eczema or other skin conditions If you are pregnant or breastfeeding, unless your doctor tells you to On broken skin, sunburnt skin or on large areas of skin

Cetostearyl alcohol and lanolin may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream. Pierce tube seal with end of cap.

Apply to the skin only.

Adults and children of 2 years and over:

Smooth a very small amount on the affected area. Use the cream 2 or 3 times a day, for a maximum of 3 days.

Do not use on children under 2 years.

If a rash develops, or the condition gets worse, stop using the cream.

If symptoms do not go away talk to your doctor.

! If anyone accidentally swallows some:

Talk to a doctor straight away.

Possible side effects

Most people will not have problems.

If you get these side effects stop using the cream and see a doctor.

Allergic reaction (e.g. skin rash, red or itchy skin, worsening of the condition you are treating)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This cream contains Mepyramine Maleate 2% w/w.

Also contains: purified water, cetostearyl alcohol, white soft paraffin, liquid paraffin, cetomacrogol 1000, anhydrous hypoallergenic lanolin, sorbitan sesquioleate, sodium citrate, citric acid monohydrate.

PL 00014/0440

Text prepared 2/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC14991 vD 15-06-07


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Lamisil AT


terbinafine hydrochloride
Dosage Form: cream
Drug Facts Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses cures most athlete’s foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions Warnings

For external use only

Do Not Use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask doctor

if too much irritation occurs or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Directions

• adults and children 12 years and over:

    • use the tip of the cap to break the seal and open the tube

    • wash the affected skin with soap and water and dry completely before applying

    • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily

        • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor

1 week between the toes

       • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

2 weeks on the bottom or sides of the foot

    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor

    • wash hands after each use

• children under 12 years: ask a doctor

Other information do not use if seal on tube is broken or is not visible store at controlled room temperature 20-25°C (68-77°F) Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions

call 1-800-452-0051

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal display panel

Lamisil AT Cream


LAMISIL  AT
terbinafine hydrochloride  cream Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-3998 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   CETYL ALCOHOL   CETYL PALMITATE   ISOPROPYL MYRISTATE   POLYSORBATE 60   WATER   SODIUM HYDROXIDE   SORBITAN MONOSTEARATE   STEARYL ALCOHOL   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0067-3998-42 1 TUBE In 1 CARTON contains a TUBE 1 12 g In 1 TUBE This package is contained within the CARTON (0067-3998-42) 2 0067-3998-30 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (0067-3998-30) 3 0067-3998-99 42 g In 1 CARTON None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020980 08/10/2005
Labeler - Novartis Consumer Health, Inc. (879821635) Revised: 01/2010Novartis Consumer Health, Inc.
More Lamisil AT resources Lamisil AT Side Effects (in more detail) Lamisil AT Use in Pregnancy & Breastfeeding Lamisil AT Support Group 4 Reviews for Lamisil AT - Add your own review/rating Lamisil AT Concise Consumer Information (Cerner Multum) Lamisil AT Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lamisil AT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Lamisil AT with other medications Tinea Corporis Tinea Cruris Tinea Pedis
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Boots Pharmacy Cold & Flu Night Liquid


Boots Pharmacy Cold & Flu Night Liquid

Specifically to: Give full strength dose of paracetamol Relieve congestion and reduce coughing Relieve fever, aches and pains Aid restful sleep

240 ml e

Read all of this carton for full instructions.

This medicine is made specially for night-time and contains a combination of ingredients to give you relief from the major symptoms of colds and flu. It relieves fever, aches and pains, nasal congestion, dry, tickly coughs and helps you sleep.

Before you take this medicine

Contains Paracetamol
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Do not take: If you are allergic to any of the ingredients If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys) If you suffer from diabetes, an overactive thyroid, glaucoma If you suffer from severe kidney disease, liver failure, long term lung problems e.g. bronchitis or bronchiectasis If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid) If you are a man with prostate problems If you are pregnant or breastfeeding Talk to your pharmacist or doctor: If you have asthma If you have other kidney or liver problems (including a disease caused by drinking alcohol) If you are on a controlled sodium diet (each 30 ml contains 33 mg of sodium) If you take other medicines Medicines for heart problems (e.g. digoxin) Medicines for high blood pressure Barbiturates (for epilepsy) Sleeping tablets Strong pain killers, sedatives, tranquillisers, tricyclic antidepressants Atropine Metoclopramide or domperidone (for feeling sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners If you suffer from alcoholism, epilepsy, brain injury or disease (this medicine contains alcohol which may be harmful to you)

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine (propylene glycol may enhance the effects of alcohol).

Information about some of the ingredients:

Each 30 ml contains 1169 mg of alcohol (ethanol) equivalent to 29 ml of beer or 12 ml of wine.

Glycerol may cause headache, stomach upset and diarrhoea.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Take at bedtime only. Use the measuring cup provided.

Adults and children of 12 years and over

Take 30 ml

At bedtime only

This medicine should be swallowed

Do not give to children under 12 years.

Warning:

Do not exceed stated dose.

Do not take this medicine for more than 7 days unless your doctor tells you to.

If symptoms persist consult your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine.

See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious.

If they bother you talk to a pharmacist:

Drowsiness, tiredness, dizziness, muscular weakness Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pains Headache, blurred vision, ringing in the ears, loss of appetite Irritability, nightmares, hallucinations (particularly in children) Fast heart rate, shaking, difficulty in passing urine, dry mouth, phlegm on the chest, sweating Skin rash Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 30 ml of oral solution contains Diphenhydramine Hydrochloride 25 mg, Paracetamol 1000 mg, Pholcodine 10 mg, Pseudoephedrine Hydrochloride 60 mg.

Also contains: glycerol (E422), propylene glycol, maltitol liquid (E965), purified water, ethanol (4.8 vol %), citric acid, sodium citrate, sodium benzoate (E211), acesulfame potassium, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, aniseed (containing benzyl alcohol, propylene glycol)).

PL 00014/0571

P

Text prepared 3/08

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC19179 vF 28/08/08


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Heparin sodium 100 IU / ml I.V. flush solution (Leo Laboratories Ltd)


1. Name Of The Medicinal Product

HEPARIN SODIUM 100 IU/ml I.V. FLUSH SOLUTION

2. Qualitative And Quantitative Composition

Heparin sodium Ph. Eur. 100 IU/ml

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

4.2 Posology And Method Of Administration

For routine use, 2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required.

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin induced thrombocytopenia.

Heparin Sodium 100 IU/ml i.v. flush solution contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

4.4 Special Warnings And Precautions For Use

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin Sodium 100 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Heparin Sodium 100 IU/ml i.v. flush solution contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic and allergic reactions (anaphylactoid) in this age group (see also section 4.3 for premature babies or neonates).

Heparin Sodium 100 IU/ml i.v. flush solution contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For incompatibilities with other medicinal products see Section 6.2.

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter the results of the tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken.

4.6 Pregnancy And Lactation

The dose of heparin used would not be expected to constitute a hazard. However, as benzyl alcohol may cross the placenta, the use of Heparin Sodium 100 IU/ml i.v. flush solution containing benzyl alcohol should be avoided during pregnancy.

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

When used as recommended, the low dose of heparin reaching the blood is unlikely to have any systemic effects. However, heparin may cause thrombocytopenia and hypersensitivity reactions.

Local irritation may occur if inadvertently injected subcutaneously.

4.9 Overdose

An overdose is unlikely to occur. Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine sulphate itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine sulphate may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol,

Methylparahydroxybenzoate,

Propylparahydroxybenzoate,

Sodium citrate,

Sodium chloride,

Water for Injections.

6.2 Incompatibilities

This product is compatible with normal saline. Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

10 x 2 ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0057

9. Date Of First Authorisation/Renewal Of The Authorisation

23 October 1978/16 January 1995

10. Date Of Revision Of The Text

November 2007

LEGAL CATEGORY

POM


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