Epanutin 100mg Hard Capsules
Out of date information, search anotherRef: 0690/300514/1/F
Epanutin® 100mg Hard Capsules
(phenytoin sodium)
Patient Information Leaflet
Your medicine is called Epanutin 100mg Hard Capsules and will be referred to as Epanutin throughout this leaflet.
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Epanutin is and what it is used for Before you take Epanutin How to take Epanutin [4 Possible side effects & How to store Epanutin Further information
^ What Epanutin is and what it is used for
Epanutin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.
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 trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have been given Epanutin Capsules.
^ Before you take Epanutin
Do not take Epanutin
* if you are allergic (hypersensitive) to Phenytoin, or any of the other ingredients of Epanutin Capsules.
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).
A small number of people being treated with anti-epileptics 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. 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.
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).
* 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 and 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).
* 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).
* Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic drugs (halothane) and methadone
* Some products available without a prescription (folic acid, theophylline, 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
Taking Epanutin with food and drink
Epanutin 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 think you might be pregnant, or are planning to get pregnant, tell your
doctor before you take Epanutin
You should not take Epanutin if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Epanutin 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.
Important information about some of the ingredients of Epanutin
Epanutin contains 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.
How to take Epanutin
It is best to take Epanutin at the same time each day.
Swallow the capsules whole, with plenty of water.
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. The dose is then adjusted up to a maximum of 300mg a day.
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.
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.
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 how to take this Epanutin, ask your doctor or pharmacist.
Epanutin ® 100mg Hard Capsules
(phenytoin sodium)
Patient Information Leaflet (continued)
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).
* 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 kidneys: 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.
* 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.
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.
Further information
What Epanutin contains
Each hard capsule contains 100mg Phenytoin sodium as the active ingredient.
Your medicine contains the following inactive ingredients: lactose monohydrate, magnesium stearate, erythrosine (E127), quinoline yellow (E104), gelatin, sodium dodecylsulfate, printing ink and titanium dioxide (E171).
What Epanutin looks like and content of the pack
Epanutin Capsules are hard gelatin capsules with a white body and a bright orange cap, both printed with ‘Epanutin 100' in black ink. The capsules are packed in a plastic container which contains a desiccant. The desiccant should not be eaten.
The capsules contain a fine white powder.
They are available in white plastic tubs of 100 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Manufacturing Deutschland GMBH, Freiburg, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
|POM| PL 15184/0690
Epanutin 100mg Hard Capsules
Epanutin is a registered trademark of Parke, Davis & Company LLC. Revision date: 30/05/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
How to store Epanutin
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C
* Store in the original package in order to protect from light.
Do not use this medicine after the expiry date shown on the carton label or bottle.
If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
If your capsules become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.