Patient Information Leaflet

Epanutin™ 30mg/5ml Oral Suspension
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 30mg/5ml Oral Suspension. Epanutin 30mg/5ml Oral Suspension is a cherry red liquid. This type of liquid is known as an oral suspension. Each 5ml spoonful contains 30mg of the active ingredient phenytoin.

The medicine also contains the other ingredients: aluminium magnesium silicate, sodium benzoate (E211), citric acid monohydrate, carmellose sodium, glycerol, polysorbate 40, sucrose, ethanol (each 5 ml dose contains 0.473% of ethanol), vanillin, banana flavour, orange oil, carmoisine (E122), sunset yellow (E110) and purified water. Epanutin 30mg/5ml Oral Suspension is available in bottles containing 500 ml of suspension.

What is Epanutin 30mg/5ml Oral Suspension?

Epanutin 30mg/5ml Oral Suspension belongs to the group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

What is Epanutin 30mg/5ml Oral Suspension used for?

Epanutin 30mg/5ml Oral Suspension can be used to control your epilepsy. Epanutin 30mg/5ml Oral Suspension can also be used to control or prevent seizures during or after brain surgery or severe head injury. It can also be used to treat trigeminal neuralgia (facial nerve pain). You should consult your doctor if you are unsure why you have been given Epanutin 30mg/5ml Oral Suspension to take.

Before taking Epanutin 30mg/5ml Oral Suspension

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?
• Have you ever had a reaction to phenytoin, phenytoin sodium, Epanutin 30mg/5ml Oral Suspension or any of its ingredients, or any other Epanutin preparation?
• Are you taking any other medicines? There is a list of medicines that Epanutin 30mg/5ml Oral Suspension interacts 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.

Can you take Epanutin 30mg/5ml Oral Suspension with other medicines?

Epanutin 30mg/5ml Oral Suspension sometimes affects the action of other medicines and sometimes Epanutin 30mg/5ml Oral Suspension is 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 30mg/5ml Oral Suspension may interact with other medicines used to treat:

• epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide 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 30mg/5ml Oral Suspension may also interact with some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill), the anaesthetic agent, halothane, muscle relaxants used for surgery (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 preparation.

If you are taking any of these medicines, tell your doctor or pharmacist before taking Epanutin 30mg/5ml Oral Suspension. Your doctor may test your blood to see if any medicines you take are affected by or affect Epanutin 30mg/5ml Oral Suspension.

Epanutin 30mg/5ml Oral Suspension may also interfere with certain laboratory tests that you may be given.

If you are being fed by a tube this can affect the concentrations of phenytoin, the active ingredient of Epanutin 30mg/5ml Oral Suspension, in your blood. Drinking a lot of alcohol can also affect the concentration of phenytoin in your blood.

How to take Epanutin 30mg/5ml Oral Suspension

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

Adults:

The amount of Epanutin 30mg/5ml Oral Suspension needed varies from one person to another. Most adults need between 200mg and 500mg a day (between 7 and 17 five-ml spoonfuls of Suspension) either as a single or divided dose. Occasionally higher doses are needed.

Children:

Infants and children usually start on a dose that depends on their weight (5mg per day for every kg they weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300mg a day (10 five-ml spoonfuls of Suspension).

Elderly:

The dose of Epanutin 30mg/5ml Oral Suspension for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.

• Shake the bottle vigorously before you measure your dose. Always use a medicine spoon or measure.
• Try to take the medicine 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 2 doses at the same time.
• If you accidentally take too much Epanutin 30mg/5ml Oral Suspension 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 is any Epanutin left or not.
• Do not stop taking Epanutin 30mg/5ml Oral Suspension 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 30mg/5ml Oral Suspension your doctor will have decided which is the best method for you.
• Sodium Benzoate, one of the ingredients in Epanutin 30mg/5ml Oral Suspension, is a mild irritant to the skin, eyes and mucous membranes. It may increase the risk of jaundice in newborn babies.
• Glycerol, one of the ingredients in Epanutin 30mg/5ml Oral Suspension, is harmful in high doses and can cause stomach upset and diarrhoea.
• This medicinal product contains 1g sucrose in each 5ml dose. It is unsuitable if you have any of the following conditions:-
  • hereditary fructose intolerance
  • glucose-galactose malabsorption syndrome
  • sucrase-isomaltase deficiency.
• WARNING: This product contains 0.473% of ethanol. Each 5ml dose contains 0.025ml of alcohol. It may be harmful for those suffering from liver disease, alcoholism, brain injury or disease as well as for pregnant women and children. May modify or increase the effect of other medicines.
• This medicine contains colouring agents (E110 and E112) that may cause allergic reactions

Side-Effects

As with all medicines, side-effects are reported with the use of Epanutin 30mg/5ml Oral Suspension. These might be:

• Effects related to the action of phenytoin, the active ingredient of Epanutin 30mg/5ml Oral Suspension on the central nervous system (brain). 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 (dizziness n 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 30mg/5ml Oral Suspension.
• If you are elderly, or have kidney or liver disease you may experience these side-effects at lower doses of Epanutin than otherwise.

• Skin rash or itchiness - many sorts of skin rash have been reported with the use of Epanutin 30mg/5ml Oral Suspension. 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 causes 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 30mg/5ml Oral Suspension 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 helps 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 30mg/5ml Oral Suspension 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.
• Additional side effects are occasionally reported for the inactive ingredients used in Epanutin 30mg/5ml Oral Suspension. These include diarrhoea and allergic type reactions, such as asthma (particularly if you are sensitive to aspirin).

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

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

How to store Epanutin 30mg/5ml Oral Suspension

• Do not use this medicine after the last day of the month shown in the expiry date. This will be printed on the bottle and the carton.
• Do not use if the medicine seems to have deteriorated.
• Remember, as with all medicines, keep Epanutin 30mg/5ml Oral Suspension out of the reach and sight of children.
• Keep Epanutin 30mg/5ml Oral Suspension in the packaging it comes in. Do not store above 25°C.