Voltarol 25mg, 50mg Rapid Tablets


VOLTAROL Rapid Tablets 25 and 50 mg

(diclofenac potassium)

What you need to know about Voltarol Rapid Tablets

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Voltarol Rapid Tablets are, and what they are used for 2. Things to consider before you start to take Voltarol Rapid Tablets 3. How to take Voltarol Rapid Tablets 4. Possible side effects 5. How to store Voltarol Rapid Tablets 6. Further information What Voltarol Rapid Tablets are and what they are used for

Diclofenac potassium, the active ingredient in Voltarol Rapid Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Voltarol Rapid Tablets relieve pain, reduce swelling and ease inflammation in: Rheumatoid arthritis, osteoarthrosis, acute gout, low back pain, ankylosing spondylitis Migraine Conditions affecting the joints and muscles such as sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations, and fractures Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with orthopaedic, dental and other minor surgery.

Things to consider before you start to take Voltarol Rapid Tablets Some people MUST NOT take Voltarol Rapid Tablets. Talk to your doctor if: you think you may be allergic to diclofenac potassium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Voltarol Rapid Tablets. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces) you have had stomach or bowel problems after you have taken other NSAIDs you have severe heart, kidney or liver failure you are more than six months pregnant. You should also ask yourself these questions before taking Voltarol Rapid Tablets: Do you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease? Do you have kidney or liver problems, or are you elderly? Do you have a condition called porphyria? Do you suffer from any blood or bleeding disorder? If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets. Have you ever had asthma? Are you breast-feeding? Do you have heart problems, or have you had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol or are a smoker)? Do you have Lupus (SLE) or any similar condition? Do you have an intolerance to some sugars such as sucrose? (Voltarol Rapid Tablets contain sucrose.)

If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Voltarol Rapid Tablets might not be the right medicine for you.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

Medicines to treat diabetes Anticoagulants (blood thinning tablets like warfarin) Diuretics (water tablets) Lithium (used to treat some mental problems) Methotrexate (for some inflammatory diseases and some cancers) Ciclosporin or tacrolimus (used to treat some inflammatory diseases and after transplants) Quinolone antibiotics (for infections) Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen Mifepristone (a medicine used to terminate pregnancy) Cardiac glycosides (for example digoxin), used to treat heart problems Medicines known as SSRIs used to treat depression Oral steroids (an anti-inflammatory drug) Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Pregnancy Are you pregnant or planning to become pregnant? Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Voltarol Rapid Tablets during the last 3 months of pregnancy as it may affect the baby’s circulation. Are you trying for a baby? Taking Voltarol Rapid Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant. Will there be any problems with driving or using machinery?

Very occasionally people have reported that Voltarol Rapid Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.

Other special warnings You should take the lowest dose of Voltarol for the shortest possible time, particularly if you are underweight or elderly. There is a small increased risk of heart attack or stroke when you are taking any medicine like Voltarol. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for. Whilst you are taking these medicines your doctor may want to give you a check-up from time to time. If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms. Because it is an anti-inflammatory medicine, Voltarol may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Voltarol. How to take Voltarol Rapid Tablets

The doctor will tell you how many Voltarol Rapid Tablets to take and when to take them. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Take the tablets with or after food.

Voltarol Rapid Tablets are specially formulated to act quickly. Swallow the tablets whole with a drink of water. Do not crush or chew them.

The usual doses are:

Adults

75 mg to 150 mg daily divided into two or three doses. The number of tablets you take will depend on the strength the doctor has given you.

For the relief of migraine in adults:

Take 50 mg at the first signs of an attack. If the migraine has not gone after 2 hours, take another 50 mg. You can take further doses at intervals of 4 to 6 hours if necessary, but you must not take more than 200 mg in a day.

Elderly

Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Voltarol Rapid Tablets are not affecting your stomach.

Children over 14

75 mg to 100 mg daily divided into two or three doses.

Voltarol Rapid Tablets are not recommended for children under 14. They are not recommended for the treatment of migraine in children of any age.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

What if you forget to take a dose?

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though, just take the next dose and forget about the one you missed. Do not double up on the next dose to make up for the one missed. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.

What if you take too many tablets?

If you, or anyone else, accidentally takes too much, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

Possible side effects

Voltarol Rapid Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop taking Voltarol Rapid Tablets and tell your doctor straight away if you notice:

Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick) Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering Wheezing or shortness of breath (bronchospasm) Swollen face, lips, hands or fingers Yellowing of your skin or the whites of your eyes Persistent sore throat or high temperature An unexpected change in the amount of urine produced and/or its appearance.

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

Up to 1 in 10 people have experienced:

Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite Headache, dizziness, vertigo Skin rash or spots Raised levels of liver enzymes in the blood.

Between 1 in 100,000 and 1 in 100 people have experienced:

Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly) Drowsiness, tiredness Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness) Skin rash and itching Fluid retention, symptoms of which include swollen ankles Liver function disorders, including hepatitis and jaundice. Isolated side-effects, reported in less than 1 in 100,000 people include:

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation.

Effects on the stomach and digestive system:

Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon).

Effects on the heart, chest or blood:

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia), heart attack, stroke.

Effects on the liver or kidneys:

Kidney or liver disorders, presence of blood or protein in the urine.

Effects on skin or hair:

Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.

Hair loss.

Other effects:

Inflammation of the pancreas, impotence.

Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

Do not be alarmed by this list - most people take Voltarol Rapid Tablets without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Voltarol Rapid Tablets

Store in a dry place, below 30°C. Keep the tablets in their original pack.

Keep out of the reach and sight of children.

Do not take Voltarol Rapid Tablets after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets, please take any unused tablets back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

Further information

The sugar-coated tablets come in two strengths containing either 25 mg or 50 mg of the active ingredient, diclofenac potassium.

The tablets also contain the inactive ingredients silica, calcium phosphate, magnesium stearate, maize starch, sodium starch glycollate, povidone, microcrystalline cellulose, red iron oxide (E172), macrogol, sucrose, talc and titanium dioxide (E171).

The tablets come in blister packs containing 2, 3, 28 or 30 tablets. Some of the pack sizes may not be marketed.

The Product licence holder is Novartis Pharmaceuticals UK Limited trading as Geigy Pharmaceuticals Frimley Business Park Frimley Camberley Surrey GU16 7SR England Voltarol Rapid Tablets are released on to the market by Novartis Pharmaceuticals UK Ltd Wimblehurst Road West Sussex RH12 5AB England

This leaflet was revised in March 2009.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

VOLTAROL is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited


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Voltarol Pain-eze Extra Strength 25mg Tablets


1. Name Of The Medicinal Product

Voltarol Pain-eze® Extra Strength 25mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains diclofenac potassium 25mg.

Chemical name: potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Pale red, round biconvex sugar-coated tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Take one tablet every 4 to 6 hours as needed. No more than 3 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Extra Strength 25mg Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Extra Strength 25mg Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patients with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Extra Strength 25mg Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

• If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Extra Strength 25mg Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Extra Strength 25mg Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: NSAID, ATC code: {M01 AB 05}

Voltarol Pain-eze Extra Strength 25mg Tablets contain the potassium salt of diclofenac, a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-pyretic properties.

Voltarol Pain-eze Extra Strength 25mg Tablets have a rapid onset of action and are therefore suitable for the treatment of acute episodes of pain and inflammation.

In migraine attacks Diclofenac potassium has been shown to be effective in relieving the headache and in improving the accompanying symptom of nausea.

Diclofenac is a potent inhibitor of prostaglandin bio-synthesis and modulator of arachidonic acid release and uptake.

Diclofenac possesses clinically demonstrable analgesic, antipyretic and anti-inflammatory effects.

Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption.

Peak plasma concentration after one 50mg sugar-coated tablet was 3.9 mmol/l after 20-60 minutes. The plasma concentrations show a linear relationship to the size of the dose.

Diclofenac undergoes first-pass metabolism and is extensively metabolised.

Distribution

Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%).

Elimination

The total systemic clearance of diclofenac in plasma is 263 + 56 ml/min (mean + SD).

The terminal half life in plasma is 1-2 hours.

Repeated oral administration of Voltarol Pain-eze Extra Strength 25mg Tablets for 8 days in daily doses of 50mg three times a day does not lead to accumulation of diclofenac in the plasma.

Approximately 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Biotransformation

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single-dose kinetics when applying the usual dosage schedule. At a creatinine clearance of <10 ml/min the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

Characteristics in patients:

The age of the patient has no influence on the absorption, metabolism, or excretion of diclofenac.

In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis) the kinetics and metabolism are the same as for patients without liver disease.

5.3 Preclinical Safety Data

Relevant information on the safety of Voltarol Pain-eze Extra Strength 25mg Tablets is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core

Aerosil 200 (silica aerogel)

Calcium phosphate, tribasic

Magnesium stearate

Maize starch

Polyvinylpyrrolidone K30, PH

Sodium carboxymethyl starch

Coating

Avicel PH 101 (cellulose)

Iron oxide, red 17266

Polyethylene glycol 8000

Polyvinylpyrrolidone K30, PH

Sucrose, cryst

Talc PH

Titanium dioxide, PH

6.2 Incompatibilities

None

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Store below 30°C and protect from moisture.

6.5 Nature And Contents Of Container

PVC/PE/PVdC blister strips containing 9 tablets.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health or Zyma Healthcare.

8. Marketing Authorisation Number(S)

PL 00030/0054.

9. Date Of First Authorisation/Renewal Of The Authorisation

03/12/2010

10. Date Of Revision Of The Text

24/05/2011

LEGAL CATEGORY

P


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Voltarol Pain-eze® Tablets


1. Name Of The Medicinal Product

Voltarol Pain-eze® Tablets

Voltarol® Joint Pain 12.5mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5 mg of diclofenac potassium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

White capsule-shaped film-coated tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Pain-eze Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Pain-eze Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Voltarol Pain-eze Tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patiens with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) ( see section 4.4 ).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code M01A B05).

Voltarol Pain-eze Tablets contain diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis is considered fundamental to its mechanism of action. Prostaglandins play a major role in causing inflammation, pain and fever.

Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in humans.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed. Following ingestion of two 12.5 mg coated tablets, mean peak plasma concentrations of 2.15 ?mol/L are attained after approximately 30 minutes (median Tmax).

The amount absorbed is in linear proportion to the size of the dose.

Since about half of diclofenac is metabolised during its first passage through the liver (“first pass” effect), the area under the concentration curve is about half as large following oral administration as it is following a parenteral dose of equal size.

Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.

Distribution

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.

Biotransformation

Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min. The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. A fifth metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. This metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.

Characteristics in patients

No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core: silica, lactose, maize starch, sodium starch glycolate, polyvidone, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

Not applicable

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

PVC/Polychlorotrifluoroethylene/PVC – Alu blister packs.

Polyamide/ALU/PVC – Alu blister packs.

Pack size: 10 or 18 tablets, not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2008

10. Date Of Revision Of The Text

29 September 2010.

LEGAL CATEGORY

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Voltarol Joint Pain 12.5mg Tablets


1. Name Of The Medicinal Product

Voltarol® Joint Pain 12.5mg Tablets

Voltarol Pain-eze® Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5 mg of diclofenac potassium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

White capsule-shaped film-coated tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Pain-eze Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Pain-eze Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Voltarol Pain-eze Tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patiens with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) ( see section 4.4 ).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code M01A B05).

Voltarol Pain-eze Tablets contain diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis is considered fundamental to its mechanism of action. Prostaglandins play a major role in causing inflammation, pain and fever.

Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in humans.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed. Following ingestion of two 12.5 mg coated tablets, mean peak plasma concentrations of 2.15 ?mol/L are attained after approximately 30 minutes (median Tmax).

The amount absorbed is in linear proportion to the size of the dose.

Since about half of diclofenac is metabolised during its first passage through the liver (“first pass” effect), the area under the concentration curve is about half as large following oral administration as it is following a parenteral dose of equal size.

Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.

Distribution

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.

Biotransformation

Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min. The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. A fifth metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. This metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.

Characteristics in patients

No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core: silica, lactose, maize starch, sodium starch glycolate, polyvidone, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

Not applicable

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

PVC/Polychlorotrifluoroethylene/PVC – Alu blister packs.

Polyamide/ALU/PVC – Alu blister packs.

Pack size: 10 or 18 tablets, not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2008

10. Date Of Revision Of The Text

29 September 2010.

LEGAL CATEGORY

P


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Isosorbide (BAN, JAN, USAN) is known as Isosorbide in the US.

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Bosnia & Herzegowina Cyprus

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Glossary

BAN British Approved Name JAN Japanese Accepted Name SPC Summary of Product Characteristics (UK) USAN United States Adopted Name
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UK matches:

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Lactaid Ultra Chewable Tablets


Pronunciation: LAK-tase
Generic Name: Lactase
Brand Name: Examples include Lactaid and Lactaid Ultra
Lactaid Ultra Chewable Tablets are used for:

Helping you consume dairy foods without gas, cramps, bloating, or diarrhea.

Lactaid Ultra Chewable Tablets are an enzyme. It works by helping the digestion of milk sugar.

Do NOT use Lactaid Ultra Chewable Tablets if: you are allergic to any ingredient in Lactaid Ultra Chewable Tablets

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

Before using Lactaid Ultra Chewable Tablets:

Some medical conditions may interact with Lactaid Ultra Chewable Tablets. 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

Some MEDICINES MAY INTERACT with Lactaid Ultra Chewable Tablets. However, no specific interactions with Lactaid Ultra Chewable Tablets are known at this time.

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

Use Lactaid Ultra Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Lactaid Ultra Chewable Tablets with the first bite or drink of dairy product. Chew thoroughly before swallowing. If you continue to consume foods containing dairy after 20 to 45 minutes, take another tablet. If you miss a dose of Lactaid Ultra Chewable Tablets, take it as soon as possible.

Ask your health care provider any questions you may have about how to use Lactaid Ultra Chewable Tablets.

Important safety information: Lactaid Ultra Chewable Tablets are not recommended for use in CHILDREN younger than 4 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: It is unknown if Lactaid Ultra Chewable Tablets may cause harm to the fetus. If you become pregnant while taking Lactaid Ultra Chewable Tablets, discuss with your doctor the benefits and risks of using Lactaid Ultra Chewable Tablets during pregnancy. It is unknown if Lactaid Ultra Chewable Tablets are excreted in breast milk. If you are or will be breast-feeding while you are taking Lactaid Ultra Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Lactaid Ultra Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Lactaid Ultra Chewable Tablets. 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).

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: Lactaid Ultra 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 Lactaid Ultra Chewable Tablets:

Store Lactaid Ultra Chewable Tablets 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. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Lactaid Ultra Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Lactaid Ultra Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Lactaid Ultra Chewable Tablets 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 Lactaid Ultra Chewable Tablets. 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.

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Methylxanthines act as bronchodilators by relaxing bronchial smooth muscle and helps the constricted airways to dilate. The exact mechanism of action with regards to methylxanthine causing bronchodilatation is not well understood but it appears that methylxanthines inhibit the enzyme phosphodiesterase, which degrades cyclic AMP, so methylxanthines tend to increase the concentration of cyclic AMP.

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Pronunciation: sih-METH-ih-cone
Generic Name: Simethicone
Brand Name: Examples include Gas-X and Maalox Anti-Gas
Maalox Anti-Gas Chewable Tablets are used for:

Relieving pressure, bloating, and gas in the digestive tract. It may also be used for other conditions as determined by your doctor.

Maalox Anti-Gas Chewable Tablets are an antiflatulent. It works by breaking up gas bubbles, which makes gas easier to eliminate.

Do NOT use Maalox Anti-Gas Chewable Tablets if: you are allergic to any ingredient in Maalox Anti-Gas Chewable Tablets

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

Before using Maalox Anti-Gas Chewable Tablets:

Some medical conditions may interact with Maalox Anti-Gas Chewable Tablets. 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 phenylketonuria

Some MEDICINES MAY INTERACT with Maalox Anti-Gas Chewable Tablets. However, no specific interactions with Maalox Anti-Gas Chewable Tablets are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Maalox Anti-Gas Chewable Tablets 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 Maalox Anti-Gas Chewable Tablets:

Use Maalox Anti-Gas Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Maalox Anti-Gas Chewable Tablets as needed after meals and at bedtime, unless otherwise directed by your doctor. Chew thoroughly before swallow. If you miss a dose of Maalox Anti-Gas Chewable Tablets and you are using it regularly, 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 Maalox Anti-Gas Chewable Tablets.

Important safety information: Do not exceed the recommended dose without checking with your doctor. If your condition persists, contact your health care provider. Phenylketonuria patients - Some versions of this product contain phenylalanine. Ask your doctor or pharmacist if Maalox Anti-Gas Chewable Tablets contains phenylalanine. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Maalox Anti-Gas Chewable Tablets, discuss with your doctor the benefits and risks of using Maalox Anti-Gas Chewable Tablets during pregnancy. It is unknown if Maalox Anti-Gas Chewable Tablets are excreted in breast milk. If you are or will be breast-feeding while you are taking Maalox Anti-Gas Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Maalox Anti-Gas Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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).

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: Maalox Anti-Gas 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 Maalox Anti-Gas Chewable Tablets:

Store Maalox Anti-Gas Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Avoid temperatures above 104 degrees F (40 degrees C). Keep Maalox Anti-Gas Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Maalox Anti-Gas Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Maalox Anti-Gas Chewable Tablets 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 Maalox Anti-Gas Chewable Tablets. 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 Maalox Anti-Gas resources Maalox Anti-Gas Side Effects (in more detail) Maalox Anti-Gas Use in Pregnancy & Breastfeeding Maalox Anti-Gas Support Group 0 Reviews for Maalox Anti-Gas - Add your own review/rating Compare Maalox Anti-Gas with other medications Endoscopy or Radiology Premedication Functional Gastric Disorder Gas Postoperative Gas Pains


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Senokot Tablets


Senokot Tablets

Senokot is a reliably effective laxative made with natural senna treated especially to yield a constant amount of active ingredient in each dose, to give predictable constipation relief.

Directions for use:

Adults and children over 12: Take 2-4 tablets at night.

Children over 6: Take 1-2 tablets in the morning.

Children 6 and under: Not recommended.

New users should start with the lowest dose and increase if necessary by one half of initial dose each day. Once regularity has been regained doses should be reduced and can usually be stopped.

Senokot usually acts within 8-12 hours. Dose can be repeated on a daily basis until bowel action is restored, but if there is no bowel movement within three days of use, consult your doctor.

Ingredients:

Each tablet contains standardised senna equivalent to 7.5mg total sennosides in a base containing lactose, calcium phosphate, maize starch and magnesium stearate.

For safe use:

Keep out of reach of children.

If laxatives are needed every day, or if abdominal pain persists, please consult your doctor.

Consult your doctor or pharmacist if:

you have sharp or persistant stomach pain your abdomen is tender to the touch or hurts when you move you accidentally take too many tablets

To open pull tab. If tab is missing do not use. Replace cap firmly after use. Store dry below 30°C. Do not use after expiry date.

You may experience temporary mild stomach pains if changing dosage.

Consult your doctor if you notice any other side effects.

Manufacturer and MA Holder: Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS UK Distributor: Britannia Pharmaceuticals Limited 41-51 Brighton Road Redhill Surrey RH1 6YS Export Distributor: Reckitt & Colman (Overseas) Limited Hull HU8 7DS

Product Licence Number: PL 0063/5000

Date of preparation: July 2005


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Senokot Tablets


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