Patient Information Leaflet

EPANUTIN® Infatabs 50mg CHEWABLE TABLETS
Phenytoin

Please read this leaflet carefully before you start to take your medicine. It contains important information about your treatment. If you have any questions, or if you are not sure about anything, ask your doctor or pharmacist.

What is in the pack?

The name of your medicine is Epanutin Infatabs 50mg Chewable Tablets. Epanutin Infatabs are spearmint flavoured chewable tablets with a breaking line on one side. Each yellow triangular tablet contains 50 mg of the active ingredient, phenytoin. The tablets also contain: sucrose (icing sugar) and sucrose solution, maize starch, saccharin sodium, spearmint flavour, talc, magnesium stearate and quinoline yellow (E104). Epanutin Infatabs are available in packs containing 112 tablets.

What are Epanutin Infatabs?

Epanutin Infatabs belong to the group of medicines known as anti-epileptic drugs; these medicines are used to treat epilepsy.

What are Epanutin Infatabs used for?

Epanutin Infatabs can be used to control your epilepsy. Epanutin Infatabs can also be used to control or prevent seizures during or after brain surgery or severe head injury. They 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 Infatabs to take.

Before taking Epanutin Infatabs

Do not take Epanutin Infatabs if you have ever had a reaction to phenytoin, phenytoin sodium, Epanutin Infatabs or any of its ingredients, or any other Epanutin preparation.

If the answer to any of the following questions is "yes", you should talk to your doctor or pharmacist before taking this medicine as it may not be suitable for you.

• Are you pregnant, trying to become pregnant, or breast-feeding?
• Are you taking any other medicines? There is a list of medicines that Epanutin Infatabs interact with in the next section.
• Do you drink large amounts of alcohol?
• Do you suffer from liver disease?
• Do you have porphyria (an inherited disease that affects haemoglobin biosynthesis)? Your doctor will tell you if you suffer from this.

This medicine may be harmful to the teeth.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Can you take Epanutin Infatabs with other medicines?

Epanutin Infatabs sometimes affect the action of other medicines and sometimes Epanutin Infatabs are affected by other medicines. Always tell your pharmacist you are taking Epanutin when you buy medicines at the chemist. If you require an operation or visit to your dentist or your doctor let them know that you are taking Epanutin.

Epanutin Infatabs may interact with other medicines used to treat:

• epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate, valproic acid, succinimides, and vigabatrin)
• fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole and miconazole)
• tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin)
• asthma and bronchitis (theophylline)
• pain and inflammation (phenylbutazone, salicylates and steroids)
• stomach ulcers (omeprazole, sucralfate, the medicines known as H2 antagonists e.g. cimetidine, ranitidine, famotidine, and some antacids)
• sleeplessness, depression and psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants and viloxazine)
• cancer (antineoplastic agents)
• organ and tissue transplants, to prevent rejection (ciclosporin)
• heart and circulation problems (dicoumarol, amiodarone, reserpine, digitoxin, furosemide, quinidine, warfarin and calcium channel blockers e.g. diltiazem and nifedipine)
• diabetes (tolbutamide)
• Epanutin Infatabs may also interact with some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill), the anaesthetic agent halothane, neuromuscular blockers, methadone and some products available without a prescription (folic acid, antacids, theophylline, vitamin D, salicylates e.g. aspirin)

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 preparations.

If you are taking any of these, tell your doctor or pharmacist before taking Epanutin. Your doctor may test your blood to see if any medicines you take are affected by or affect Epanutin Infatabs.

• Epanutin Infatabs may also interfere with a number of blood tests you may be given, namely mineral and vitamin level measurements and tests of thyroid and liver function.
• Excessive alcohol intake can affect the concentration of phenytoin, the active ingredient of Epanutin Infatabs, in your blood.

How to take Epanutin Infatabs

Follow your doctor's instructions exactly and never change the dose yourself. Your doctor will have decided what dose of Epanutin Infatabs is right for you. Your doctor may need to test your blood to help decide this.

Adults: The amount of Epanutin needed varies from one person to another. Most people need between 200 mg and 500 mg a day, either as a single or divided dose. Occasionally higher doses are needed.

Children: Infants and children usually start on a dose that depends on their weight (5 mg per day for every kg they weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300 mg a day.

Elderly: The dose of Epanutin Infatabs for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.

• Chew the Infatabs or swallow them whole with plenty of water.
• Try to take the tablets at the same time every day.
• 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 two doses at the same time.
• If you accidentally take too many Epanutin Infatabs tell your doctor at once. If you cannot do this, go to the nearest accident and emergency (casualty) department. Always take the labelled medicine package with you, whether there are any Epanutin Infatabs left or not.
• Do not stop taking Epanutin Infatabs 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.

Side-effects

As with all medicines, side-effects are reported with the use of Epanutin Infatabs. These might be:

• Effects related to the action of phenytoin, the active ingredient of Epanutin Infatabs on the central nervous system (brain and spinal cord). These include: unusual eye movements, unsteadiness, difficulty in controlling movements, shaking, abnormal or uncoordinated movements, slurred speech, confusion, pins and needles or numbness, drowsiness, dizziness or vertigo (spinning sensation or feeling loss of balance in high places), sleeplessness, nervousness, twitching muscles, headaches, loss of feeling in the hands or feet.

• Some of the above side-effects may also occur when the concentration of phenytoin in your blood is too high.
• When extremely high amounts of phenytoin are in the blood, extreme confusion sometimes referred to as delirium, psychosis or encephalopathy (a brain disease) has been reported. On rare occasions, when the amount of phenytoin in the blood has remained high for a long time, irreversible brain injury has occurred. Your doctor may test your blood to see how much phenytoin is in it and change your dose of Epanutin Infatabs.
• If you are elderly, or have kidney or liver disease you may experience these side- effects at lower doses of Epanutin.

• Skin rash or itchiness - many sorts of skin rash have been reported with the use of Epanutin Infatabs. Some are minor (for example, measles-like or mild dermatitis) but others, although rare, are more serious such as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN), which cause blistering and can affect the mouth and tongue. Rash may also be a first sign of other side-effects of Epanutin. If you get a rash, your doctor may advise you to stop taking Epanutin Infatabs until it clears up. If the rash recurs, does not clear up or a serious reaction is suspected, your doctor may advise you not to take Epanutin or phenytoin again.
• Hypersensitivity reaction or syndrome. Fever, skin rash, swollen glands may occur, usually within the first two months of treatment. Changes in liver function, increased numbers of white blood cells and joint pains may occur as part of this syndrome.

• Inflammation in various parts of your body including the joints, skin and kidneys, a condition known as systemic lupus erythematosus, may occur on rare occasions. A rash may be the first sign of this condition but it may also be noticed as fever, pain in the joints and general ill health.
• Inflammation of the walls of the arteries and problems with the body's defence against infection (the immune system) have also been seen.
• Although still rare, you may be more likely to get this syndrome, skin rash or liver damage, if you are black.

• Swelling of the lymph glands (a part of your body's natural defence system) and other disorders of the lymph glands may occur. This may be accompanied by fever or rash and may affect your liver as described above as a hypersensitivity reaction but may also be a sign of a problem with your lymph glands.
• Abnormalities of the blood including decreases in the number of red cells, white cells or platelets (parts of the blood which help it to clot). The first signs you might notice could be bruising, fever, pallor or sore throat. Your doctor may take regular blood samples to test for this.
• Hepatitis (inflammation of the liver) or liver damage which may be recognised by yellowing of the skin and whites of the eyes and changes in liver function.
• Nausea, vomiting, constipation.
• Inflammation of the kidneys.
• Breathing problems, mainly inflammation of the lining of the lung.
• Rare side-effects have included: 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, changes in the shape of the penis and painful erection, a condition affecting your joints known as polyarthropathy.
• Increased levels of blood sugar, or decreased levels of blood calcium or folic acid.
• Epanutin Infatabs may alter the amount of vitamin D in your body. 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. Rickets (abnormal development of bone) may occur if this effect is prolonged.

Do not be alarmed by this list - most people take Epanutin without any problems.

If you get any of these, or any other problems, talk to your doctor or pharmacist straight away and continue to take your medicine.

How to store Epanutin Infatabs 50mg Chewable Tablets

• Do not use this medicine after the last day of the month shown in the expiry date. This will be printed on the outside of the pack.
• Remember, as with all medicines, keep Epanutin Infatabs out of the reach and sight of children.
• Keep Epanutin Infatabs in the packaging it comes in. Do not store above 30°C.

Remember

This medicine is only for you. Only your doctor can prescribe Epanutin Infatabs for you. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.