Package leaflet: Information for the user

Epanutin® 100mg Hard Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

The name of your medicine is Epanutin 100mg Hard Capsules but will be referred to as Epanutin throughout the remainder of 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.    How to take Epanutin

4.    Possible side effects

5.    How to store Epanutin

6.    Contents of the pack and other information

1. WHAT EPANUTIN® IS AND WHAT IT IS USED FOR

Epanutin Hard Capsules are one of a group of medicines called antiepileptic 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.

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 Hard Capsules work and Epanutin Hard 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 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. If you find out you are pregnant, then you should continue to take your medicine until you have spoken to your doctor for advice. This is because Phenytoin should only be used during pregnancy, especially early pregnancy, under the advice of your doctor because it can be harmful to unborn children when taken by a woman during pregnancy. Do not stop taking your medicine until your doctor tells you to.

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 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.

3. HOW TO TAKE EPANUTIN®

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 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 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 Hard Capsules are 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 are any Epanutin Hard Capsules 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 forgotten 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 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 longterm antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 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 the capsules becomes discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will advise you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Epanutin contains

Each hard capsule contains 100mg of the active ingredient, phenytoin sodium.

The other ingredients are lactose monohydrate, magnesium stearate, erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl sulphate, titanium dioxide (E171) and black printing ink.

What Epanutin looks like and the contents of the pack

Epanutin 100mg capsules are half white and half orange marked with 'Epanutin 100' in black printing ink containing white powder.

Epanutin is available in packs containing 100 capsules.

| POM | PL No: 33652/0066 - Epanutin® 100mg Hard Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg, Germany and procured from within the EU by the Product Licence Holder Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park, Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.

Epanutin® is a registered trademark of Flynn Pharma Ltd. Revision date: 1st November 2016

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

The name of your medicine is Phenytoin Sodium Pharmaram 100mg Hard Capsules but will be referred to as Phenytoin Sodium Pharmaram throughout the remainder of this leaflet.

What is in this leaflet:

1.    What Phenytoin Sodium Pharmaram is and what it is used for

2.    What you need to know before you take Phenytoin Sodium Pharmaram

3.    How to take Phenytoin Sodium Pharmaram

4.    Possible side effects

5.    How to store Phenytoin Sodium Pharmaram

6.    Contents of the pack and other information

1. WHAT PHENYTOIN SODIUM PHARMARAM IS AND WHAT IT IS USED FOR

Phenytoin Sodium Pharmaram Hard Capsules are one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Phenytoin Sodium Pharmaram 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 Pharmaram 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 Pharmaram.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENYTOIN SODIUM PHARMARAM

Do not take Phenytoin Sodium Pharmaram

•    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 Pharmaram.

Medicines are not always suitable for everyone. Your doctor needs to know before you take Phenytoin Sodium Pharmaram 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 Pharmaram. 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 Pharmaram.

Other medicines and Phenytoin Sodium Pharmaram

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 Pharmaram Hard Capsules work and Phenytoin Sodium Pharmaram Hard 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.

Phenytoin Sodium Pharmaram capsules may also interfere with certain laboratory tests that you may be given.

Phenytoin Sodium Pharmaram with food and drink

Phenytoin Sodium Pharmaram 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. If you find out you are pregnant, then you should continue to take your medicine until you have spoken to your doctor for advice. This is because Phenytoin should only be used during pregnancy, especially early pregnancy, under the advice of your doctor because it can be harmful to unborn children when taken by a woman during pregnancy. Do not stop taking your medicine until your doctor tells you to.

Breast-feeding

You should not take Phenytoin Sodium Pharmaram if you are breastfeeding.

Driving and using machines

Phenytoin Sodium Pharmaram 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 Pharmaram 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.

3. HOW TO TAKE PHENYTOIN SODIUM PHARMARAM

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 Pharmaram at the same time each day.

Swallow the capsules whole, with plenty of water.

The amount of Phenytoin Sodium Pharmaram 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 Phenytoin Sodium Pharmaram 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 Pharmaram than you should

Phenytoin Sodium Pharmaram Hard Capsules are dangerous in overdose. If you accidentally take too much Phenytoin Sodium Pharmaram 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 Phenytoin Sodium Pharmaram Hard Capsules left or not.

If you forget to take Phenytoin Sodium Pharmaram

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 Phenytoin Sodium Pharmaram

Do not stop taking Phenytoin Sodium Pharmaram 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 Pharmaram, 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 longterm antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PHENYTOIN SODIUM PHARMARAM

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 Phenytoin Sodium Pharmaram 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 the capsules becomes discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will advise you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Phenytoin Sodium Pharmaram contains

Each hard capsule contains 100mg of the active ingredient, phenytoin sodium.

The other ingredients are lactose monohydrate, magnesium stearate, erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl sulphate, titanium dioxide (E171) and black printing ink.

What Phenytoin Sodium Pharmaram looks like and the contents of the pack

Phenytoin Sodium Pharmaram 100mg capsules are half white and half orange marked with 'Epanutin 100' in black printing ink containing white powder.

Phenytoin Sodium Pharmaram is available in packs containing 100 capsules.

PL No: 33652/0066 - Phenytoin Sodium Pharmaram 100mg Hard Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg, Germany and procured from within the EU by the Product Licence Holder Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park, Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.

Revision date: 1st November 2016

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

The name of your medicine is Phenytoin Sodium Flynn 100mg Hard Capsules but will be referred to as Phenytoin Sodium Flynn throughout the remainder of this leaflet.

What is 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.    How to take Phenytoin Sodium Flynn

4.    Possible side effects

5.    How to store Phenytoin Sodium Flynn

6.    Contents of the pack and other information

1. WHAT PHENYTOIN SODIUM FLYNN IS AND WHAT IT IS USED FOR

Phenytoin Sodium Flynn Hard Capsules are one of a group of medicines called anti-epileptic 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 Hard Capsules work and Phenytoin Sodium Flynn Hard 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.

Phenytoin Sodium Flynn capsules 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. If you find out you are pregnant, then you should continue to take your medicine until you have spoken to your doctor for advice. This is because Phenytoin should only be used during pregnancy, especially early pregnancy, under the advice of your doctor because it can be harmful to unborn children when taken by a woman during pregnancy. Do not stop taking your medicine until your doctor tells you to.

Breast-feeding

You should not take Phenytoin Sodium Flynn if you are breast-feeding. 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 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.

3. HOW TO TAKE PHENYTOIN SODIUM FLYNN

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.

The amount of Phenytoin Sodium Flynn 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 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 Hard Capsules are 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 are any Phenytoin Sodium Flynn Hard Capsules 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 forgotten 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 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 longterm antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. You can also report side

effects directly via www.mhra.gov.uk/yellowcard. 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 store above 25°C. Store in the original package in order to protect from light.

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.

If the capsules becomes discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will advise you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Phenytoin Sodium Flynn contains

Each hard capsule contains 100mg of the active ingredient, phenytoin sodium.

The other ingredients are lactose monohydrate, magnesium stearate, erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl sulphate, titanium dioxide (E171) and black printing ink.

What Phenytoin Sodium Flynn looks like and the contents of the pack

Phenytoin Sodium Flynn 100mg capsules are half white and half orange marked with 'Epanutin 100' in black printing ink containing white powder.

Phenytoin Sodium Flynn is available in packs containing 100 capsules.

PL No: 33652/0066 - Phenytoin Sodium Flynn 100mg Hard Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg, Germany and procured from within the EU by the Product Licence Holder Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park, Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.

Phenytoin Sodium Flynn is a registered trademark of Flynn Pharma Ltd. Revision date: 1st November 2016

P-PILPHENSODFLYNN100MGX100 (ES) V2.2