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.

What is in this leaflet

• 1) What Phenytoin tablets are and what they are used for

• 2) What you need to know before you take Phenytoin tablets

• 3) How to take Phenytoin tablets

• 4) Possible side effects

• 5) How to store Phenytoin tablets

• 6) Contents of the pack and other information

1) What Phenytoin tablets are and what they are used for

Phenytoin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Phenytoin tablets can be used to control a variety of epileptic conditions (tonic-clonic seizures and partial seizures), to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin 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 tablets.

Note: Phenytoin sodium is not effective in absence status epilepticus or in the prophylaxis and treatment of febrile convulsions.

2) what you need to know before you take phenytoin tablets

Do not take Phenytoin tablets

• 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. Medicines are not always suitable for everyone.

Your doctor needs to know before you take phenytoin if you suffer from or have suffered in the past from any of the following conditions:

• liver disease
• kidney disease
• Porphyria (an inherited disease that affects haemoglobin biosynthesis)

Phenytoin is not effective for the seizure type, absence (petit mal) seizures.

Phenytoin may affect the breakdown of the sugar, glucose, and may prevent the release of the hormone, insulin which could lead to high blood sugar. This is particularly important if you are diabetic.

Phenytoin may precipitate or aggravate certain forms of epilepsy (absence seizures and myoclonic seizures).

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.

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin Tablets, 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 Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenytoin Tablets, you must not be re-started on Phenytoin Tablets at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

Serious skin side effects can rarely occur during treatment with phenytoin. 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 (HLAB* 1502), discuss this with your doctor before taking Phenytoin tablets.

You should be administered phenytoin with caution if you suffer from kidney or liver problems.

Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions Other medicines and Phenytoin tablets

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 works, or Phenytoin 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, and calcium channel blockers e.g. diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, disopyramide and verapamil).
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin and simvastatin)
• Medicines used for epilepsy (carbamazepine, oxcarbazepine, topiramate, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and voriconazole).
• Medicines used for tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline, clarithromycin, sulfadiazine, sulfamethoxazole-trimethoprim, 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 to expel parasitic worms (helminths) from the body (antihelminthics).
• 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 like Pancuronium, Rocuronium, Vecuronium), 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 tablets may also interfere with certain laboratory tests that you may be given.

Phenytoin with food, drink and alcohol

Phenytoin tablets 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 may 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 tablets if you are breast-feeding.

Driving and using machines

Phenytoin 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 Tablets contains Sodium.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3) how to take phenytoin tablets

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 tablets at the same time each day. Swallow the tablets whole, with plenty of water

Adults

The amount of Phenytoin Tablets 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 and patients with kidney or liver disease

The dose of Phenytoin Tablets for elderly patients, patients with kidney or liver disease, or those who may be taking other medicines may also need careful consideration and adjustment by their doctor.

If you take more Phenytoin tablets than you should

Phenytoin is dangerous in overdose. If you accidentally take too many Phenytoin tablets 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 tablets left or not.

If you forget to take Phenytoin tablets

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 tablets

Do not stop taking Phenytoin tablets 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 tablets, your doctor will decide which method is best 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.
• 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 (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS))
• 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.

Some of the following adverse reactions frequencies could not be determined from available data and are therefore not known. They have been reported spontaneously during the postmarketing period.

• 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: megaloblastic anaemia (disease with unusually large, structurally abnormal, immature red blood cells), decreased bone marrow function and 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, phosphate, folic acid and vitamin D and abnormal thyroid function test results. 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 and immunoglobin abnormalities.
• 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.

Additional side effects that can occur in children

The adverse event profile of phenytoin is generally similar between children and adults. Swollen gums occur more frequently in paediatric patients and in patients with poor oral hygiene.

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5) how to store phenytoin tablets

• Keep out of the sight and reach of children.
• Store in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date (EXP) which is stated on the carton and foil.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6) contents of the pack and other information

What Phenytoin tablets contain

• The active substance is phenytoin sodium. Each film-coated tablet contains 100 mg of phenytoin sodium.
• The other ingredients are

Tablet Core: Mannitol, Crospovidone (Type B), Crospovidone (Type A), Croscarmellose sodium, Magnesium stearate.

Tablet Coat: Hypromellose, Macrogol 400, Titanium dioxide (E171) and Sodium lauryl sulfate.

What Phenytoin tablets look like and contents of the pack

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.

What is in this leaflet

• 1) What Phenytoin tablets are and what they are used for

• 2) What you need to know before you take Phenytoin tablets

• 3) How to take Phenytoin tablets

• 4) Possible side effects

• 5) How to store Phenytoin tablets

• 6) Contents of the pack and other information

1) What Phenytoin tablets are and what they are used for

Phenytoin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Phenytoin tablets can be used to control a variety of epileptic conditions (tonic-clonic seizures and partial seizures), to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin 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 tablets.

Note: Phenytoin sodium is not effective in absence status epilepticus or in the prophylaxis and treatment of febrile convulsions.

2) what you need to know before you take phenytoin tablets

Do not take Phenytoin tablets

• 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. Medicines are not always suitable for everyone.

Your doctor needs to know before you take phenytoin if you suffer from or have suffered in the past from any of the following conditions:

• liver disease
• kidney disease
• Porphyria (an inherited disease that affects haemoglobin biosynthesis)

Phenytoin is not effective for the seizure type, absence (petit mal) seizures.

Phenytoin may affect the breakdown of the sugar, glucose, and may prevent the release of the hormone, insulin which could lead to high blood sugar. This is particularly important if you are diabetic.

Phenytoin may precipitate or aggravate certain forms of epilepsy (absence seizures and myoclonic seizures).

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.

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin Tablets, 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 Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenytoin Tablets, you must not be re-started on Phenytoin Tablets at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

Serious skin side effects can rarely occur during treatment with phenytoin. 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 (HLAB* 1502), discuss this with your doctor before taking Phenytoin tablets.

You should be administered phenytoin with caution if you suffer from kidney or liver problems.

Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions Other medicines and Phenytoin tablets

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 works, or Phenytoin 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, and calcium channel blockers e.g. diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, disopyramide and verapamil).
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin and simvastatin)
• Medicines used for epilepsy (carbamazepine, oxcarbazepine, topiramate, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and voriconazole).
• Medicines used for tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline, clarithromycin, sulfadiazine, sulfamethoxazole-trimethoprim, 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 to expel parasitic worms (helminths) from the body (antihelminthics).
• 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 like Pancuronium, Rocuronium, Vecuronium), 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 tablets may also interfere with certain laboratory tests that you may be given.

Phenytoin with food, drink and alcohol

Phenytoin tablets 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 may 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 tablets if you are breast-feeding.

Driving and using machines

Phenytoin 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 Tablets contains Sodium.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3) how to take phenytoin tablets

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 tablets at the same time each day. Swallow the tablets whole, with plenty of water

Adults

The amount of Phenytoin Tablets 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 and patients with kidney or liver disease

The dose of Phenytoin Tablets for elderly patients, patients with kidney or liver disease, or those who may be taking other medicines may also need careful consideration and adjustment by their doctor.

If you take more Phenytoin tablets than you should

Phenytoin is dangerous in overdose. If you accidentally take too many Phenytoin tablets 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 tablets left or not.

If you forget to take Phenytoin tablets

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 tablets

Do not stop taking Phenytoin tablets 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 tablets, your doctor will decide which method is best 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.
• 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 (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS))
• 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.

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5) how to store phenytoin tablets

• Keep out of the sight and reach of children.
• Store in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date (EXP) which is stated on the carton and foil.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6) contents of the pack and other information

What Phenytoin tablets contain

• The active substance is phenytoin sodium. Each film-coated tablet contains 100 mg of phenytoin sodium.
• The other ingredients are

Tablet Core: Mannitol, Crospovidone (Type B), Crospovidone (Type A), Croscarmellose sodium, Magnesium stearate.

Tablet Coat: Hypromellose, Macrogol 400, Titanium dioxide (E171) and Sodium lauryl sulfate.

What Phenytoin tablets look like and contents of the pack

White to off-white, oval shaped, film-coated tablets debossed with ‚C‘ on one side and ‚70‘ on the other side.

Phenytoin tablets are available in blister packs of 50, 100 and 200 tablets.

PL 46 420/0284 Phenytoin sodium Milpharm 100mg film-coated tablets POM

Who makes and repackages your medicine?

Your medicine is manufactured by APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 21.08.2020

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 020 8839 3000 to obtain the leaflet in a format suitable for you.

Your medicine is known by the above name but will be referred to as Phenytoin tablets or as Phenytoin throughout this:

Patient Information Leaflet

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.

What is in this leaflet

• 1) What Phenytoin tablets are and what they are used for

• 2) What you need to know before you take Phenytoin tablets

• 3) How to take Phenytoin tablets

• 4) Possible side effects

• 5) How to store Phenytoin tablets

• 6) Contents of the pack and other information

• 1) What Phenytoin tablets are and what they are used for

Phenytoin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Phenytoin tablets can be used to control a variety of epileptic conditions (tonic-clonic seizures and partial seizures), to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin 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 tablets.

Note: Phenytoin sodium is not effective in absence status epilepticus or in the prophylaxis and treatment of febrile convulsions.

2) what you need to know before you take phenytoin tablets

Do not take Phenytoin tablets

• 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. Medicines are not always suitable for everyone.

Your doctor needs to know before you take phenytoin if you suffer from or have suffered in the past from any of the following conditions:

• liver disease
• kidney disease
• Porphyria (an inherited disease that affects haemoglobin biosynthesis)

Phenytoin is not effective for the seizure type, absence (petit mal) seizures.

Phenytoin may affect the breakdown of the sugar, glucose, and may prevent the release of the hormone, insulin which could lead to high blood sugar. This is particularly important if you are diabetic.

Phenytoin may precipitate or aggravate certain forms of epilepsy (absence seizures and myoclonic seizures).

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.

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin Tablets, 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 Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenytoin Tablets, you must not be re-started on Phenytoin Tablets at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

Serious skin side effects can rarely occur during treatment with phenytoin. 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 (HLAB* 1502), discuss this with your doctor before taking Phenytoin tablets.

You should be administered phenytoin with caution if you suffer from kidney or liver problems.

Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions Other medicines and Phenytoin tablets

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 works, or Phenytoin 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, and calcium channel blockers e.g. diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, disopyramide and verapamil).
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin and simvastatin)
• Medicines used for epilepsy (carbamazepine, oxcarbazepine, topiramate, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and voriconazole).
• Medicines used for tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline, clarithromycin, sulfadiazine, sulfamethoxazole-trimethoprim, 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 to expel parasitic worms (helminths) from the body (antihelminthics).
• 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 like Pancuronium, Rocuronium, Vecuronium), 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 tablets may also interfere with certain laboratory tests that you may be given.

Phenytoin with food, drink and alcohol

Phenytoin tablets 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 may 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 tablets if you are breast-feeding.

Driving and using machines

Phenytoin 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 Tablets contains Sodium.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3) how to take phenytoin tablets

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 tablets at the same time each day. Swallow the tablets whole, with plenty of water

Adults

The amount of Phenytoin Tablets 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 and patients with kidney or liver disease

The dose of Phenytoin Tablets for elderly patients, patients with kidney or liver disease, or those who may be taking other medicines may also need careful consideration and adjustment by their doctor.

If you take more Phenytoin tablets than you should

Phenytoin is dangerous in overdose. If you accidentally take too many Phenytoin tablets 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 tablets left or not.

If you forget to take Phenytoin tablets

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 tablets

Do not stop taking Phenytoin tablets 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 tablets, your doctor will decide which method is best 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.
• 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 (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS))
• 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.

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5) how to store phenytoin tablets

• Keep out of the sight and reach of children.
• Store in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date (EXP) which is stated on the carton and foil.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6) contents of the pack and other information

What Phenytoin tablets contain

• The active substance is phenytoin sodium. Each film-coated tablet contains 100 mg of phenytoin sodium.
• The other ingredients are

Tablet Core: Mannitol, Crospovidone (Type B), Crospovidone (Type A), Croscarmellose sodium, Magnesium stearate.

Tablet Coat: Hypromellose, Macrogol 400, Titanium dioxide (E171) and Sodium lauryl sulfate.

What Phenytoin tablets look like and contents of the pack

White to off-white, oval shaped, film-coated tablets debossed with ‚C‘ on one side and ‚70‘ on the other side.

Phenytoin tablets are available in blister packs of 50, 100 and 200 tablets.

PL 46 420/0284 Phenytoin sodium Primecrown 100mg film-coated tablets POM

Who makes and repackages your medicine?

Your medicine is manufactured by APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 21.08.2020

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Is this leaflet hard to see or read?

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Some of the following adverse reactions frequencies could not be determined from available data and are therefore not known. They have been reported spontaneously during the postmarketing period.

• 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: megaloblastic anaemia (disease with unusually large, structurally abnormal, immature red blood cells), decreased bone marrow function and 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, phosphate, folic acid and vitamin D and abnormal thyroid function test results. 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 and immunoglobin abnormalities.
• 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.