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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epanutin®

Infatabs 50mg Chewable Tablets

(Phenytoin)

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In this leaflet:

1.    What Epanutin Infatabs are and what they are used for

2.    Before you take Epanutin

3.    How to take Epanutin

4.    Possible side effects

5.    How to store Epanutin

6.    Further information

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Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

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1. What Epanutin Infatabs are and what they are used for

Epanutin is one of a group of medicines called anti-epileptic drugs; these medicines are usually used to treat epilepsy and prevent or treat seizures. Epanutin can be used to control a variety of epileptic conditions, to control or prevent seizures during or after brain surgery or severe head injury. Epanutin can also be used to treat a condition called trigeminal neuralgia (which causes facial nerve pain).

You should consult your doctor if you are unsure why you have been given Epanutin Infatabs.

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2. Before you take Epanutin

Do not take Epanutin

•    if you are allergic (hypersensitive) to phenytoin, or any of the other ingredients of Epanutin Infatabs.

Take special care with EPANUTIN

Medicines are not always suitable for everyone. Your doctor needs to know before you take Epanutin if you suffer from or have suffered in the past from any of the following conditions:

•    Liver disease.

•    Porphyria (an inherited disease that affects haemoglobin biosynthesis).

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A small number of people being treated with antiepileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Epanutin, you must not be re-started on Epanutin at any time.    ₆

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If you develop a rash or these skin symptoms, stop taking Epanutin, seek urgent advice from a doctor and tell him that you are taking this medicine. Consult your doctor before discontinuing Epanutin. If you suddenly stop taking this medicine you may have a seizure.

This risk of these serious skin side effects may be associated with a variant in genes in a subject with Chinese or Thai origin. If you are of such origin and have been tested previously carrying this genetic variant (HLA-B*1502), discuss this with your doctor before taking Epanutin.

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Taking other medicines

Some medicines can affect the way Epanutin works, or Epanutin itself can reduce the effectiveness of other medicines taken at the same time. These include:

•    Medicines used for heart and circulation problems (dicoumarol, digitoxin, amiodarone, furosemide, quinidine, reserpine, warfarin, and calcium channel blockers e.g. diltiazem and nifedipine).

•    Medicines used for epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide and vigabatrin).

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•    Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole and miconazole).

•    Medicines used for tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline, ciprofloxacin and nelfinavir).

•    Medicines used for stomach ulcers (omeprazole, sucralfate, the medicines known as H2 antagonists e.g. cimetidine, ranitidine, famotidine and some antacids).

•    Medicines used for asthma and bronchitis (theophylline).

•    Medicines used for pain and inflammation (phenylbutazone, salicylates e.g. aspirin and steroids).

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•    Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetics (halothane) and methadone.

•    Some products available without a prescription (folic acid, theophylline, vitamin D).

Your doctor may need to monitor the amount of phenytoin in your blood to help decide if any of these drugs are affecting your treatment.

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

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3. How to take Epanutin

Chew the Infatabs or swallow them whole with plenty of water.

It is best to take Epanutin at the same time each day.

Adults

The amount of Epanutin needed varies from one person to another. Most adults need between 200mg and 500mg a day either as a single or divided dose. Occasionally higher doses are needed.

Children

Infants and children usually start on a dose that depends on their weight (5mg per day for every kg they weigh) and is given as a divided dose, twice a day.

15 The dose is then adjusted up to a maximum of 300mg a day.

•    Medicines used for sleeplessness, depression and psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants, fluvoxamine, sertraline and viloxazine).

•    Medicines used for diabetes (tolbutamide).

•    Some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill).

•    Medicines used for organ and tissue transplants, to prevent rejection (ciclosporin).

•    Medicines used for cancer (antineoplastic agents such as fluorouracil).

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The herbal preparation St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparation.

Epanutin Infatabs may also interfere with certain laboratory tests that you may be given.

Taking Epanutin with food and drink

Epanutin can be used before or after food and drinks. Drinking a lot of alcohol can also affect the concentration of phenytoin in your blood.

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Elderly

The dose of Epanutin for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.

Always take Epanutin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are still not sure.

If you take more Epanutin than you should

Epanutin is dangerous in overdose. If you accidentally take too much Epanutin contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Epanutin left or not.

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If you forget to take Epanutin

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

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If you stop taking Epanutin

Do not stop taking Epanutin unless your doctor tells you to. If you suddenly stop taking this medicine you may have a seizure. Should you need to stop taking Epanutin, your doctor will have decided which the best method is for you.

3 g

If you have any further questions on how to take this product, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, Epanutin can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.

•    Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). There is a higher incidence of this in black patients.

•    If you develop potentially life-threatening skin rashes that cause blistering, (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN). These have been reported very rarely. Your doctor will stop your treatment in these cases.

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•    If you notice bruising, fever, you are looking pale or you have a severe sore throat. These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects.

•    Skin rash and fever with swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction. If these are severe and you also experience pain and inflammation of the joints this could be related to a condition called systemic lupus erythematosus.

•    Skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) as they may be signs of a hypersensitivity reaction.

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•    If you experience confusion or have a severe mental illness, as this may be a sign that you have high amounts of phenytoin in your blood. Your doctor may test your blood to see how much phenytoin is in the blood and may change your dose.

Other side-effects that may occur are:

•    Effects on your nervous system: Unusual eye movements, unsteadiness, difficulty in controlling movements, shaking, abnormal or uncoordinated movements, slurred speech, confusion, pins and needles or numbness, drowsiness, dizziness, vertigo, sleeplessness, nervousness, twitching muscles, headaches and change in taste.

•    Effects on your skin: skin rash including measles-like reactions which are mild.

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•    Effects on your stomach and intestines: feeling sick, being sick and constipation.

• Effects on your blood and lymph system: swelling of the lymph glands.

• Effects on your liver and kidney: inflammation of the kidneys and liver, liver damage (seen as yellowing of the skin and whites of the eye).

•    Effects on your reproductive system and breasts: changes in the shape of the penis, painful erection.

•    Effects on your hands, face and body: changes in the hands with difficulty in straightening the fingers, changes in facial features, enlarged lips or gums, increased or abnormal body or facial hair.

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•    Effects on medical tests: Increased levels of blood sugar, or decreased levels of blood calcium, phosphate, folic acid and vitamin D. If you also do not get enough vitamin D in your diet or from exposure to sunlight, you may suffer from bone and muscle pain or fractures.

•    Effects on your respiratory system: problems breathing, inflammation of the lining of the lung.

•    Effects on your immune system: problems with the body's defence against infection, inflammation of the wall of the arteries and immunoglobin abnormalities.

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• Effects on your bones: There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

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.

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5. How to store Epanutin

Keep out of the reach and sight of children.

Store in the original package in order to protect from moisture.

Do not store above 25°C.

Do not use Epanutin after the expiry date which is stamped on the label. The expiry date refers to the last day of that month.

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

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6. Further Information

What Epanutin Infatabs 50mg contain

Each yellow triangular tablet contains 50mg of the active ingredient phenytoin. The other ingredients are sucrose (icing sugar), maize, starch, saccharin sodium, spearmint flavour, talc, magnesium stearate, quinoline yellow (E104) and sunset yellow (E110).

What Epanutin Infatabs look like and contents of the pack

Epanutin Infatabs are spearmint flavoured yellow, triangular chewable tablets with flat sides, a bevelled edge and breaking line on one side with P-D 007 imprinted on the other side. Epanutin Infatabs are available in a HDPE bottle containing 200 tablets.

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Manufacturer

Pfizer Service Company BVBA Hoge Wei 10 B-1930 Zaventem Belgium

Company Contact Address

For further information on your medicine please contact Medical Information at the following address: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone: 01304 616161 Leaflet last revised: 10/2012 Ref: EP 3_0

₂₇    LLXXXX

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