EPANUTIN 100 MG CAPSULES - patient leaflet, side effects, dosage

Epanutin

(phenytoin sodium)

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.

What is in this leaflet:

• 1. What Epanutin Capsules are and what they are used for

2. What you need to know before you take Epanutin Capsules

3. How to take Epanutin Capsules

4. Possible side effects

• 5. How to Epanutin Capsules

6. Contents of the pack and other information

• 1. What Epanutin Capsules are and what they are used for

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

Epanutin 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 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 Capsules.

2. what you need to know before you take epanutin capsules

Do not take Epanutin 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 Capsules.

Medicines are not always suitable for everyone.

Your doctor needs to know before you take Epanutin 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 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 Capsules.

Other medicines and Epanutin 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 Capsules work and Epanutin 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 Capsules may also interfere with certain laboratory tests that you may be given.

Epanutin Capsules with food and drink Epanutin 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 Capsules if you are breast-feeding.

Driving and using machines

Epanutin 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 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.

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You will find more about Epanutin Capsules on the back of this leaflet

3. How to take Epanutin Capsules

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 Capsules at the same time each day.

Swallow the capsules whole, with plenty of water.

Adults

The amount of Epanutin 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 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 Capsules than you should Epanutin Capsules are dangerous in overdose .

If you accidentally take too much Epanutin 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 Capsules left or not.

If you forget to take Epanutin 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 Capsules

Do not stop taking Epanutin 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 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.

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).
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store epanutin capsules

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package. Protect from light.

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

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.

6. contents of the pack and other information

What Epanutin Capsules contain

• The active substance is phenytoin sodium.
• Each hard capsule contains 100mg phenytoin sodium.
• The other ingredients are lactose monohydrate, magnesium stearate and sodium lauryl sulfate.
• The gelatin capsule shells are marked with printing ink and contain the colouring titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104).

What Epanutin Capsules look like and contents of the pack

Epanutin 100mg Capsules are half white and half orange hard capsules marked with “Epanutin 100”.

The capsules are packed in a plastic container containing 100 capsules and a desiccant. The desiccant should not be eaten.

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Frieburg site

Mooswaldallee 1

D-79090 Freiburg

Germany

Procured from within the EU and repackaged by the Product Licence holder: Shakespeare Pharma Ltd., 1B Harrison Court, Hilton Business Park, Hilton, DE65 5UR, UK.

Epanutin 100mg capsules PL 40593/0001

This leaflet was last revised on 14 December 2015