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Package leaflet: Information for the user

EPANUTIN 100 MG CAPSULES

(phenytoin sodium)

What is in this leaflet:

1)    What Epanutin 100 mg Capsules are and what they are used for

2)    What you need to know before you take Epanutin 100 mg Capsules

3)    How to take Epanutin 100 mg Capsules

4)    Possible side effects

5)    How to store Epanutin 100 mg Capsules

6)    Contents of the pack and other information

1) WHAT EPANUTIN 100 MG CAPSULES ARE AND| WHAT THEY ARE USED

Epanutin 100 mg Capsules are one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Epanutin 100 mg Capsules 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 100 mg Capsules can also be used to treat trigeminal neuralgia (facial nerve pain).

You should ask your doctor if you are unsure why you have been given Epanutin 100 mg Capsules.

2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE| EPANUTIN 100 MG CAPSULES^^^^^^^^H

Do not take Epanutin 100 mg Capsules

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

•    if you are allergic to other medicines with a similar chemical structure to Phenytoin (e.g. hydantoins).

Warnings and precautions

Talk to your doctor or pharmacist before taking Epanutin 100 mg Capsules.

Medicines are not always suitable for everyone. Your doctor needs to know before you take Epanutin 100 mg Capsules 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).

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

Serious skin side effects can rarely occur during treatment with Epanutin 100 mg Capsules.

This risk 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 100 mg Capsules.

Other medicines and Epanutin 100 mg Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can affect the way Epanutin 100 mg Capsules work and Epanutin 100 mg Capsules themselves can reduce the effectiveness of other medicines taken at the same time. These include:

•    Medicines used for heart and circulation problems (amiodarone, digoxin, furosemide, reserpine, warfarin, calcium channel blockers e.g. diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, and verapamil)

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

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

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

•    Medicines used for tuberculosis and other infections (chloramphenicol, clarithromycin, isoniazid, rifampicin, sulphonamides, sulfadiazine, sulfamethoxazole-trimethoprim, doxycycline, ciprofloxacin, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and saquinavir)

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

•    Medicines used for asthma and bronchitis (theophylline)

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

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

•    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 and tacrolimus)

•    Medicines used for cancer (antineoplastic agents, e.g. bleomycin, capecitabine, carboplatin, cisplatin, doxorubicin, fluorouracil and methotrexate)

•    Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic drugs (methadone)

•    Some products available without a prescription (folic acid, theophylline, St John's Wort, vitamin D).

Your doctor may need to test the amount of Phenytoin in your blood to help decide if any of these medicines are affecting your treatment.

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 100 mg Capsules may also interfere with certain laboratory tests that you may be given.

Epanutin 100 mg Capsules with food and drink

Epanutin 100 mg Capsules can be taken before or after food and drinks. Drinking a lot of alcohol can also affect the concentration of Phenytoin in your blood.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding

You should not take Epanutin 100 mg Capsules if you are breastfeeding.

Driving and using machines

Epanutin 100 mg Capsules may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use any tools or machinery.

Epanutin 100 mg Capsules contain lactose, 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.

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

It is best to take Epanutin 100 mg Capsules at the same time each day.

Swallow the capsules whole, with plenty of water.

Adults

The amount of Epanutin 100 mg Capsules 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.

Use in children and adolescents

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

Elderly

The dose of Epanutin 100 mg Capsules for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.

If you take more Epanutin 100 mg Capsules than you should

Epanutin 100 mg Capsules are dangerous in overdose. If you accidentally take too much Epanutin 100 mg Capsules contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Epanutin 100 mg Capsules left or not.

If you forget to take Epanutin 100 mg Capsules

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 forgotten dose.

If you stop taking Epanutin 100 mg Capsules

Do not stop taking Epanutin 100 mg Capsules 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 100 mg Capsules, your doctor will have decided which is the best method for you.

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

Like all medicines, Epanutin 100 mg Capsules 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).

•    If you develop a severe skin rash that causes blistering,

(this can also affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN). Your doctor will stop your treatment in these cases.

•    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.

•    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. On rare occasions, when the amount of phenytoin in the blood remains high, irreversible brain injury has occurred. 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 taste change.

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

•    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: 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.

•    Effects on medical tests: increased levels of blood sugar, or decreased levels of blood calcium, 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 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.

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

•    Do not store above 25°C.

•    Store in the original package in order to protect from light.

•    Keep out of the sight and reach of children.

•    Do not use Epanutin 100 mg Capsules after the expiry date on the pack. The expiry date refers to the last day of that month.

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

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.

6) CONTENTS OF THE PACK AND OTHE INFORMATION^^^^^^^H

What Epanutin 100 mg Capsules contain

Epanutin 100 mg Capsules contain 100 mg of the active ingredient, phenytoin sodium.

The other ingredients are lactose monohydrate and magnesium stearate.

The capsule shell contains: gelatin, titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104).

The printing ink components are, depending on the ink used: shellac, black iron oxide (E172) and N-butyl alcohol, propylene glycol, industrial methylated spirit 74 OP, isopropyl alcohol and water, or shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide and water.

What Epanutin 100 mg Capsules look like and contents of the pack

Epanutin 100 mg Capsules is a white powder in a hard gelatin capsule with a white opaque body and orange cap, radially printed 'EPANUTIN 100' available in packs containing 100 capsules. The capsules are packed in a plastic container which contains a desiccant. The desiccant should not be eaten.

Manufacturer

This product is manufactured by:

Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg Mooswaldallee 1, 79090 Freiburg,

Germany.

It is procured within the EU and repackaged by Mediwin Limited, Product Licence Holder Mediport Limited,

13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United Kingdom.

PL 18980/0846

Date of leaflet preparation: 08/10/2014

PIL_8340189800846_S0003