EPANUTIN 30MG/5ML ORAL SUSPENSION
Active substance: PHENYTOIN
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1
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Patient Information Leaflet
UNITED KINGDOM
1. What Epanutin is and what it is used for
Epanutin is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy. Epanutin can be used to control epilepsy, 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 consult your doctor if you are unsure why you have been given Epanutin 30mg/5ml Oral Suspension.
Epanutin 30mg/5ml
Oral Suspension
phenytoin
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2. Before you take Epanutin
Do not take Epanutin
if you are allergic (hypersensitive) to Phenytoin, or any of the other ingredients of Epanutin 30mg/5ml Suspension.
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 antiepileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Potentially life-threatening skin rashes (Stevens Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed StevensJohnson syndrome or toxic epidermal necrolysis with the use of Epanutin, you must not be re-started on Epanutin at any time. If you develop a rash or these skin symptoms, stop taking Epanutin, seek urgent advice from a doctor
In this leaflet: 1. What Epanutin is and what it is used for 2. Before you take Epanutin 3. How to take Epanutin 4. Possible side effects 5. How to store Epanutin 6. Further information
Drugs used for organ and tissue transplants, to prevent rejection (ciclosporin). Muscle relaxants used for surgery (neuromuscular blockers), methadone and some products available without a prescription (folic acid, theophylline, vitamin D). Some anaesthetic drugs (halothane). Your doctor may need to test the amount of phenytoin in your blood to help decide if any of these drugs are affecting your treatment. Taking other medicines Please tell your doctor or pharmacist if you are Some medicines can affect the way Epanutin taking or have recently taken any other medicines, works, or Epanutin itself can reduce the including medicines obtained without a prescription. effectiveness of other medicines taken at the The herbal preparation St Johns wort (Hypericum same time. These include: perforatum) should not be taken at the same time Drugs used for heart and circulation problems as this medicine. If you already take St Johns wort, (dicoumarol, digitoxin, amiodarone, furosemide, consult your doctor before stopping the St Johns quinidine, reserpine, warfarin, and calcium wort preparation. channel blockers e.g. diltiazem and nifedipine). Drugs used for epilepsy (carbamazepine, If you are being fed by a tube this can affect the lamotrigine, phenobarbital, sodium valproate and concentrations of phenytoin, the active ingredient of valproic acid, succinimides e.g. ethosuximide and Epanutin 30mg/5ml Oral Suspension, in your blood. vigabatrin). Your doctor or pharmacist will tell you how to take Drugs used to treat fungal infections (e.g. this medicine with your feeds. amphotericin B, fluconazole, itraconazole, Epanutin 30mg/5ml Oral Suspension may also ketoconazole and miconazole). interfere with certain laboratory tests that you may Drugs used for tuberculosis and other infections be given. (chloramphenicol, isoniazid, rifampicin, Taking Epanutin with food and drink sulphonamides, doxycycline, ciprofloxacin and Epanutin can be used before or after food and nelfinavir). drinks. Drugs used for stomach ulcers (omeprazole, sucralfate, the medicines known as H2 Drinking a lot of alcohol can also affect the antagonists e.g. cimetidine, ranitidine, famotidine concentration of phenytoin in your blood. Talk to and some antacids). your doctor or pharmacist for advice. Drugs used for asthma and bronchitis Pregnancy and Breast-feeding (theophylline). If you think you might be pregnant, or are planning Drugs used for pain and inflammation to get pregnant, tell your doctor before you take (phenylbutazone, salicylates e.g. aspirin and Epanutin. steroids). You should not take Epanutin if you are breast Drugs used for sleeplessness, depression and psychiatric disorders (chlordiazepoxide, clozapine, feeding. diazepam, disulfiram, fluoxetine, methylphenidate, Ask your doctor or pharmacist for advice before paroxetine, phenothiazines, trazodone, tricyclic taking any medicine. antidepressants, fluvoxamine, sertraline and Driving and using machines viloxazine). Epanutin may cause dizziness or drowsiness, Drugs used for diabetes (tolbutamide). Drugs used for cancer (antineoplastic agents such especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use as fluorouracil). any tools or machinery. Some hormone replacement therapies (oestrogens), oral contraceptives (the You will find more about EPANUTIN on the back of this leaflet birth control pill).
and tell him that you are taking this medicine. Consult your doctor before discontinuing Epanutin. If you suddenly stop taking this medicine you may have a seizure. This risk of these serious skin side effects 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.
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4
Important information about some of the ingredients of Epanutin
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose. Epanutin contains sucrose, 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. This medicine may be harmful to the teeth. This medicine contains azo colouring agents (E110 and E112) that may cause allergic reactions.
Do not take a double dose to make up for a missed dose.
5. How to store Epanutin
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 change in taste. 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 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 bodys 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. Keep out of the reach and sight of children. Do not store above 25C. 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.
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. If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. 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 potentially life-threatening skin rashes that cause 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). These have been reported very rarely. 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. Skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) as they may be signs of a hypersensitivity reaction. 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. Your doctor may test your blood to see how much phenytoin is in the blood and may change your dose.
3. How to take Epanutin
Shake the bottle vigorously before you measure your dose. Always use a medicine spoon or measure. It is best to take Epanutin at the same time each day.
6. Further information
What Epanutin 30mg/5ml Oral Suspension contains
Each 5ml dose contains 30mg of the active ingredient phenytoin. The other ingredients are aluminium magnesium silicate, sodium benzoate (E211), citric acid monohydrate, carmellose sodium, glycerol, polysorbate 40, sucrose, ethanol (each 5 ml dose contains 0.493% of ethanol), vanillin, banana flavour, orange oil, carmoisine (E122), sunset yellow (E110) and purified water.
Adults
The amount of Epanutin needed varies from one person to another. Most adults need between 200mg and 500mg a day (between 7 and 17 five-ml spoonfuls of Suspension) 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 (10 five-ml spoonfuls of Suspension).
What Epanutin looks like and contents of the pack
Epanutin 30mg/5ml Oral Suspension is a cherry red liquid and is available in bottles containing 500ml of suspension.
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.
Marketing Authorisation Holder
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
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.
Manufacturer
McNeil Manufacturing, 5 Avenue de Concyr, 45071 Orleans, Cedex 02, France.
Contact information
For further information on this medicine please contact Pfizer Medical Information on 01304 616161. Date leaflet last revised: 10/2012 Ref: EP 12_0.
F309266
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.
2
Patient Information Leaflet
UNITED KINGDOM
1. What Epanutin is and what it is used for
Epanutin is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy. Epanutin can be used to control epilepsy, 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 consult your doctor if you are unsure why you have been given Epanutin 30mg/5ml Oral Suspension.
Epanutin 30mg/5ml
Oral Suspension
phenytoin
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2. Before you take Epanutin
Do not take Epanutin
if you are allergic (hypersensitive) to Phenytoin, or any of the other ingredients of Epanutin 30mg/5ml Suspension.
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 antiepileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Potentially life-threatening skin rashes (Stevens Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed StevensJohnson syndrome or toxic epidermal necrolysis with the use of Epanutin, you must not be re-started on Epanutin at any time. If you develop a rash or these skin symptoms, stop taking Epanutin, seek urgent advice from a doctor
In this leaflet: 1. What Epanutin is and what it is used for 2. Before you take Epanutin 3. How to take Epanutin 4. Possible side effects 5. How to store Epanutin 6. Further information
Drugs used for organ and tissue transplants, to prevent rejection (ciclosporin). Muscle relaxants used for surgery (neuromuscular blockers), methadone and some products available without a prescription (folic acid, theophylline, vitamin D). Some anaesthetic drugs (halothane). Your doctor may need to test the amount of phenytoin in your blood to help decide if any of these drugs are affecting your treatment. Taking other medicines Please tell your doctor or pharmacist if you are Some medicines can affect the way Epanutin taking or have recently taken any other medicines, works, or Epanutin itself can reduce the including medicines obtained without a prescription. effectiveness of other medicines taken at the The herbal preparation St Johns wort (Hypericum same time. These include: perforatum) should not be taken at the same time Drugs used for heart and circulation problems as this medicine. If you already take St Johns wort, (dicoumarol, digitoxin, amiodarone, furosemide, consult your doctor before stopping the St Johns quinidine, reserpine, warfarin, and calcium wort preparation. channel blockers e.g. diltiazem and nifedipine). Drugs used for epilepsy (carbamazepine, If you are being fed by a tube this can affect the lamotrigine, phenobarbital, sodium valproate and concentrations of phenytoin, the active ingredient of valproic acid, succinimides e.g. ethosuximide and Epanutin 30mg/5ml Oral Suspension, in your blood. vigabatrin). Your doctor or pharmacist will tell you how to take Drugs used to treat fungal infections (e.g. this medicine with your feeds. amphotericin B, fluconazole, itraconazole, Epanutin 30mg/5ml Oral Suspension may also ketoconazole and miconazole). interfere with certain laboratory tests that you may Drugs used for tuberculosis and other infections be given. (chloramphenicol, isoniazid, rifampicin, Taking Epanutin with food and drink sulphonamides, doxycycline, ciprofloxacin and Epanutin can be used before or after food and nelfinavir). drinks. Drugs used for stomach ulcers (omeprazole, sucralfate, the medicines known as H2 Drinking a lot of alcohol can also affect the antagonists e.g. cimetidine, ranitidine, famotidine concentration of phenytoin in your blood. Talk to and some antacids). your doctor or pharmacist for advice. Drugs used for asthma and bronchitis Pregnancy and Breast-feeding (theophylline). If you think you might be pregnant, or are planning Drugs used for pain and inflammation to get pregnant, tell your doctor before you take (phenylbutazone, salicylates e.g. aspirin and Epanutin. steroids). You should not take Epanutin if you are breast Drugs used for sleeplessness, depression and psychiatric disorders (chlordiazepoxide, clozapine, feeding. diazepam, disulfiram, fluoxetine, methylphenidate, Ask your doctor or pharmacist for advice before paroxetine, phenothiazines, trazodone, tricyclic taking any medicine. antidepressants, fluvoxamine, sertraline and Driving and using machines viloxazine). Epanutin may cause dizziness or drowsiness, Drugs used for diabetes (tolbutamide). Drugs used for cancer (antineoplastic agents such especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use as fluorouracil). any tools or machinery. Some hormone replacement therapies (oestrogens), oral contraceptives (the You will find more about EPANUTIN on the back of this leaflet birth control pill).
and tell him that you are taking this medicine. Consult your doctor before discontinuing Epanutin. If you suddenly stop taking this medicine you may have a seizure. This risk of these serious skin side effects 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.
3
4
Important information about some of the ingredients of Epanutin
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose. Epanutin contains sucrose, 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. This medicine may be harmful to the teeth. This medicine contains azo colouring agents (E110 and E112) that may cause allergic reactions.
Do not take a double dose to make up for a missed dose.
5. How to store Epanutin
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 change in taste. 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 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 bodys 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. Keep out of the reach and sight of children. Do not store above 25C. 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.
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. If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. 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 potentially life-threatening skin rashes that cause 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). These have been reported very rarely. 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. Skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) as they may be signs of a hypersensitivity reaction. 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. Your doctor may test your blood to see how much phenytoin is in the blood and may change your dose.
3. How to take Epanutin
Shake the bottle vigorously before you measure your dose. Always use a medicine spoon or measure. It is best to take Epanutin at the same time each day.
6. Further information
What Epanutin 30mg/5ml Oral Suspension contains
Each 5ml dose contains 30mg of the active ingredient phenytoin. The other ingredients are aluminium magnesium silicate, sodium benzoate (E211), citric acid monohydrate, carmellose sodium, glycerol, polysorbate 40, sucrose, ethanol (each 5 ml dose contains 0.493% of ethanol), vanillin, banana flavour, orange oil, carmoisine (E122), sunset yellow (E110) and purified water.
Adults
The amount of Epanutin needed varies from one person to another. Most adults need between 200mg and 500mg a day (between 7 and 17 five-ml spoonfuls of Suspension) 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 (10 five-ml spoonfuls of Suspension).
What Epanutin looks like and contents of the pack
Epanutin 30mg/5ml Oral Suspension is a cherry red liquid and is available in bottles containing 500ml of suspension.
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.
Marketing Authorisation Holder
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
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.
Manufacturer
McNeil Manufacturing, 5 Avenue de Concyr, 45071 Orleans, Cedex 02, France.
Contact information
For further information on this medicine please contact Pfizer Medical Information on 01304 616161. Date leaflet last revised: 10/2012 Ref: EP 12_0.
F309266
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.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
