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Package leaflet: Information for the patient

Epanutin®

Infatabs 50mg Chewable Tablets

(Phenytoin)

SUB1055

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50.8 mm

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet

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

2.    What you need to know before you take Epanutin

3.    How to take Epanutin

4.    Possible side effects

5.    How to store Epanutin

6.    Contents of the pack and other information

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

This medicine contains phenytoin, which 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, if you do not feel better or if you feel worse.

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2. What you need to know before you take Epanutin Do not take Epanutin

•    if you are allergic (hypersensitive) to phenytoin, or any of the other ingredients of this medicine (listed in section 6)

•    if you are allergic to other medicines for epilepsy

•    if you are also taking delavirdine (used for HIV therapy).

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Warnings and precautions

Talk to your doctor or pharmacist 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)

•    Alcohol dependence.

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

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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.

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.

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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.

Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions.

Other medicines and Epanutin

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

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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 (e.g. dicoumarol, digitoxin, digoxin, mexiletine, nisoldipine, amiodarone, furosemide, quinidine, reserpine, warfarin, and calcium channel blockers including diltiazem and nifedipine)

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

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

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

•    Medicines used for diabetes (e.g. tolbutamide)

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

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

•    Medicines used for cancer (antineoplastic agents such as teniposide, fluorouracil, capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate)

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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.

Epanutin with food, drink and alcohol

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

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Epanutin contains sucrose and the colouring agent sunset yellow (E110)

Epanutin contains sucrose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

It may be harmful to the teeth.

The colouring agent sunset yellow (E110), which is present in the yellow tablets may cause allergic reactions.

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•    Medicines used for tuberculosis and other infections (e.g. chloramphenicol, isoniazid, rifampicin, sulfonamides, sulfadiazine, sulfamethiazole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, doxycycline and ciprofloxacin)

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

•    Medicines used for asthma and bronchitis (e.g. theophylline)

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

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•    Medicines used to lower high blood cholesterol and triglycerides (e.g. atorvastatin, fluvastatin, simvastatin)

•    Medicines used in the treatment of HIV infection (e.g. delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)

•    Medicines used to expel parasitic worms from the body (e.g. albendazole, praziquantel)

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

•    Some products available without a prescription (e.g. folic acid, 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.

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Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not breast feed if you are taking Epanutin.

Driving and using machines

Epanutin may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery and contact your doctor.

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3. How to take Epanutin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Chew the Epanutin 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 200 mg and 500 mg a day either as a single or divided dose. Occasionally higher doses are needed.

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Children and adolescents

Infants and children usually start on a dose that depends on their weight (5 mg per day for every kg they weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300 mg a day.

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Older people

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

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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.

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.

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

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4. Possible side effects

Like all medicines, this medicine 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.

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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 (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS)).

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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 or liver failure which can lead to death (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.

•    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.

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5. How to store Epanutin

Keep this medicine out of the sight and reach of children.

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

Do not store above 25°C.

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Do not use this medicine after the expiry date which is printed on the label after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

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6. Contents of the pack and other information What Epanutin Infatabs 50 mg contains

Each yellow triangular tablet contains 50 mg 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.    ₂₈

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Marketing Authorisation Holder UK

Pfizer Limited

Ramsgate Road, Sandwich

Kent

CT13 9NJ UK

Ireland

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Park, Citywest Business Campus Dublin 24, Ireland

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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 Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone: 01304 616161

This leaflet was last revised in Ireland: MM/YYYY

This leaflet was last revised in United Kingdom 09/2015

Ref: EP 6_4    ^SUB1055

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