Epanutin 100 Mg Hard Capsules
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER 1. What Epanutin is and what it is used for
Epanutin®
100 mg Hard Capsules
(phenytoin sodium)
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.
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.
The name of your medicine is Epanutin 100 mg Hard Capsules but it will be referred as Epanutin throughout this leaflet.
What is in this leaflet:
1. What Epanutin is and what it is used for
2. What you need to know before you take Epanutin
3. Howto take Epanutin
4. Possible side effects
5. Howto store Epanutin
6. Contents of the pack and other information
2. What you need to know before you take Epanutin
Do not take Epanutin
• 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.
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 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. 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.
Other medicines and Epanutin
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 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 (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 may also interfere with certain laboratory tests that you may be given.
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 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 if you are breast-feeding.
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.
Epanutin 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 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 200 mg and 500 mg 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 (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.
Elderly
The dose of Epanutin for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.
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.
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 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 ofthe lining of the lung.
• Effects on your immune system: problems with the body’s defence against infection, inflammation ofthe wall ofthe arteries.
• Effects on your bones: There have been reports of bone disorders including osteopenia and osteoporosis (thinning ofthe 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 the Yellow Card Scheme at:
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Epanutin
Do not use Epanutin after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month. 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.
6. Contents of the pack and other information
What Epanutin contains
Epanutin 100 mg Capsules contain 100 mg ofthe active ingredient, phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate. The capsule shells contain gelatin, the colouring titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172), N-butyl alcohol, propylene glycol, industrial methylated spirit 74 OP, isopropyl alcohol and water.
What Epanutin looks like and contents of the pack
Epanutin 100 mg capsules are half white and half orange hard capsules marked with “Epanutin 100” and available in packs containing 100 capsules.
The capsules are packed in a plastic container which contains a desiccant. The desiccant should not be eaten.
Manufactured by: Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, D-79090, Freiburg, Germany.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL
Epanutin6 100 mg Hard Capsules, PL 39352/0067
Epanutin is a registered trademark of Pfizer limited. Leaflet date: 20.08.2014
Keep out of the sight and reach of children.
1. What Phenytoin Sodium Flynn is and what it is used for
Phenytoin Sodium Flynn
100 mg Hard Capsule
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.
The name of your medicine is Phenytoin Sodium Flynn 100 mg Hard Capsule but it will be referred as Phenytoin Sodium Flynn throughout this leaflet.
In this leaflet:
1. What Phenytoin Sodium Flynn is and what it is used for
2. What you need to know before you take Phenytoin Sodium Flynn
3. Howto take Phenytoin Sodium Flynn
4. Possible side effects
5. Howto store Phenytoin Sodium Flynn
6. Contents of the pack and other information
Phenytoin Sodium Flynn is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium Flynn 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 Sodium Flynn 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 Sodium Flynn.
2. What you need to know before you take Phenytoin Sodium Flynn
Do not take Phenytoin Sodium Flynn
• 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 Phenytoin Sodium Flynn
Medicines are not always suitable for everyone. Your doctor needs to know before you take Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn.
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 Phenytoin Sodium Flynn.
Other medicines and Phenytoin Sodium Flynn
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way Phenytoin Sodium Flynn works, or Phenytoin Sodium Flynn itself 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.
Phenytoin Sodium Flynn may also interfere with certain laboratory tests that you may be given.
Phenytoin Sodium Flynn with food and drink
Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn if you are breastfeeding.
Driving and using machines
Phenytoin Sodium Flynn 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.
Phenytoin Sodium Flynn contain lactose, a type of sugar.
Phenytoin Sodium Flynn 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.
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 Phenytoin Sodium Flynn at the same time each day. Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Flynn 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.
Use in 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.
Elderly
The dose of Phenytoin Sodium Flynn for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.
If you take more Phenytoin Sodium Flynn than you should
Phenytoin sodium Flynn is dangerous in overdose. If you accidentally take too much Phenytoin sodium Flynn 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 Sodium Flynn left or not.
If you forget to take Phenytoin Sodium Flynn
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 Sodium Flynn
Do not stop taking Phenytoin Sodium Flynn 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 sodium Flynn, your doctor will have decided which the best method is for you.
If you have any further questions on how to take this Phenytoin Sodium Flynn, ask your doctor or pharmacist.
Like all medicines, Phenytoin Sodium Flynn 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.
POM
• 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 ofthe lining of the lung.
• Effects on your immune system: problems with the body’s defence against infection, inflammation ofthe wall ofthe arteries.
• Effects on your bones: There have been reports of bone disorders including osteopenia and osteoporosis (thinning ofthe 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 the Yellow Card Scheme at:
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Phenytoin Sodium Flynn
Keep out of the sight and reach of children.
Do not use Phenytoin Sodium Flynn after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Phenytoin Sodium Flynn contains
Phenytoin Sodium Flynn 100 mg Capsules contain 100 mg ofthe active ingredient, phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate. The capsule shells contain gelatin, the colouring titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172) aN-butyl alcohol, propylene glycol, industrial methylated spirit 74 OP, isopropyl alcohol and water.
What Phenytoin Sodium Flynn looks like and contents ofthe pack
Phenytoin Sodium Flynn 100 mg Hard Capsules are half white and half orange hard capsules marked with “Epanutin100” and available in packs containing 100 capsules.
The capsules are packed in a plastic container which contains a desiccant. The desiccant should not be eaten.
Manufactured by: Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, D-79090, Freiburg, Germany.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL
Phenytoin Sodium Flynn 100 mg Hard Capsules,
PL 39352/0067
Leaflet date: 20.08.2014
Do not store above 25°C. Store in the original package in order to
protect from light.