Phenytoin Sodium Flynn100mg Hard Capsules
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POM
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 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 longterm antiepileptic medication, have a history of osteoporosis, or take steroids.
5. Howto store Phenytoin Hard Capsules
Keep out of the sight and reach of children Do not store above 25°C. Store in the original package. Protect from light.
Do not use after expiry date which is stamped on the pack. The expiry date refers to the last day of that month. If the capsules show any signs of discolouration or deterioration consult your pharmacist for advice.
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.
Remember: This medicine is only for you. Only your doctor can prescribe Phenytoin Hard Capsules for you. Never give it to anyone else. They may harm them even if their symptoms are the same as yours.
6. Further Information
What Phenytoin Hard Capsules contains
Each hard capsule is half white and half orange marked with ‘Epanutin 100’ in black printing ink containing white powder.
Each hard capsule contains 100mg of the active ingredient phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate, gelatin, sodium lauryl sulphate, black printing ink, Titanium Dioxide E171, erythrosine E127 and Quinoline Yellow E104.
Contains a dessicant. The dessicant should not be eaten.
Your medicine is available in pack of 100 capsules.
PL 20774/1380 Phenytoin Hard Capsules
Manufactured by: Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg Mooswaldallee 1 79090 Friburgo, Germany. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, LynstockWay, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
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.
Revision Date: 6th January 2014
Epanutin is a registered trademark of Parke, Davis & Company LLC.
Phenytoin Sodium Flynn 100mg Hard Capsules Epanutin® 100mg Hard Capsules
(phenytoin sodium)
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 onto 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.
Your medicine is available in any of the above two names, but will be referred to as Phenytoin Hard Capsules throughout the remainder of the leaflet.
In this leaflet:
1. What Phenytoin Hard Capsules are and what they are used for.
2. Before you take Phenytoin Hard Capsules
3. Howto take Phenytoin Hard Capsules
4. Possible side effects
5. How to store Phenytoin Hard Capsules
6. Further information
1. What Phenytoin Capsules are and what they are used for.
Phenytoin Hard Capsules is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Hard 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. Phenytoin Hard 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 Phenytoin Hard Capsules.
2. Before you take Phenytoin Hard Capsules Do not take Phenytoin Hard Capsules
• If you are allergic (hypersensitive) to Phenytoin, or any of the other ingredients of Phenytoin Hard Capsules
Take special care with Phenytoin Hard Capsules
Medicines are not always suitable for everyone. Your doctor needs to know before you take Phenytoin Hard 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 anti-epileptics such as phenytoin 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 Phenytoin Hard Capsules. This risk may be associated with a variant in genes in a subject of Chinese or Thai origin. If you are of such origin and have been tested positively carrying this generic variant (HLA-B*1502), discuss this with your doctor before taking Phenytoin Hard Capsules.
Taking other medicines Some medicines can affect the way Phenytoin Hard Capsules work, or Phenytoin Hard Capsules 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. dilitazem 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 (chlorodiazepoxide, 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 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 St John’s wort preparation.
Phenytoin Hard Capsules may also interfere with certain laboratory tests that you may be given.
Taking Phenytoin Hard Capsules with food and drink
Phenytoin Hard 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 think you might be pregnant, or are planning to get pregnant, tell your doctor before you take Phenytoin Hard Capsules
You should not take Phenytoin Hard Capsules if you are breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Phenytoin Hard 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.
Important information about some of the ingredients of Phenytoin Hard Capsules
Phenytoin Hard 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.
3. Howto take Phenytoin Hard Capsules
It is best to take Phenytoin Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Hard Capsules 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.
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 300 mg a day.
Elderly
The dose of Phenytoin Hard Capsules for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.
Always take Phenytoin Hard Capsules as your doctor has told you. You should check with your doctor or pharmacist if you are still not sure.
If you take more Phenytoin Hard Capsules than you should
Phenytoin Hard Capsules are dangerous in overdose. If you accidentally take too many Phenytoin Hard Capsules 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 Phenytoin Hard Capsules left or not.
If you forget to take Phenytoin Hard 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 missed dose.
If you stop taking Phenytoin Hard Capsules
Do not stop taking Phenytoin Hard 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 Phenytoin Hard Capsules, your doctor will have decided which the best method is for you. If you have any further questions on how to take these Phenytoin Hard Capsules, ask your doctor or pharmacist.
4. Possible Side-Effects
Like all medicines, Phenytoin Hard 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 a state of 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.
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