THE NAME OF YOUR MEDICINE IS EPISENTA PROLONGED-RELEASE CAPSULES.

Episenta 500 mg and Episenta 1000 mg are available as aluminium sachets that contain white prolonged-release granules. The prolonged-release granules contain the active ingredient sodium valproate. Each sachet of Episenta 500 mg and Episenta 1000 mg contains 500 mg and 1000 mg of Sodium Valproate, respectively.

Other ingredients in Episenta 500 mg and Episenta 1000 mg include:
calcium stearate, silicon dioxide (methylated), ammonio methacrylate copolymer type B, ethylcellulose, dibutylsebacate and oleic acid.

The following pack sizes are available:
Episenta 500 mg:                50, 100 and 200 PET/Aluminium/PE sachets
Episenta 1000 mg:              50, 100 and 200 PET/Aluminium/PE sachets

The active ingredient belongs to a group of medicines known as anticonvulsants which are used in the treatment of epilepsy (fits).

The Product Licence holder is Beacon Pharmaceuticals Ltd., Tunbridge Wells, TN1 1YG, UK

Manufactured by Desitin Arzneimittel GmbH, Weg Beim Jäger 214, D-22335 Hamburg, Germany.

WHAT IS EPISENTA FOR?

Episenta prolonged-release capsules are used in the treatment of various types of epilepsy.

BEFORE TAKING THIS MEDICINE.

You should not take Episenta if

-  you have been told that you are allergic to sodium valproate or other constituents of the product

-  you have liver disease

You should tell your doctor if you are pregnant or intend to become pregnant or wish to start breast feeding whilst taking these prolonged-release granules.

You may need to have periodic blood tests to check your levels of sodium valproate and to check for blood or liver problems. 
You will need to discuss with your doctor whether you should drive or operate machinery, which will depend on how well your disease is controlled and whether Episenta makes you drowsy.

There may be some problems when Episenta is taken with other medicines including some other anticonvulsant drugs (phenytoin, carbamazepine and phenobarbitone), cimetidine (an anti ulcer drug), aspirin and agents which are used to thin the blood (e.g. warfarin), and some drugs for mental illness, including depression. It may be necessary to alter the dose of Episenta or the other medicine.

This includes some medicines you can buy without a prescription. So make sure your doctor knows what other medicines you are taking including those you may buy directly from the chemist.

If you have any doubts about whether you should take these prolonged-release granules then discuss things more fully with your doctor BEFORE taking them.

TAKING THIS MEDICINE.

Dosage requirements vary according to your age and body weight and are adjusted individually by your doctor to achieve adequate seizure control.

Usual requirements are as follows:

Adults: The usual adult starting dose is 600mg a day, increasing by 150-300mg/day every 3 days until control of fits is achieved. This is generally within the dosage range of 1000mg to 2000mg per day i.e. 20-30mg/kg body weight daily.  Where adequate control is not achieved within this range the dose may be further increased to a maximum of 2500mg per day.

Children over 20kg: Initial dosage should be 300mg/day increasing until control is achieved.  This is usually within the range 20-30mg/kg body weight per day. Where adequate control is not achieved within this range, the dose may be increased to 35 mg/kg body weight per day.

Children under 20kg: 20mg/kg of body weight per day; in severe cases this may be increased up to 40mg/kg/day.

Elderly patients and patients with renal insufficiency may need lower doses. In certain cases it may be necessary to raise or increase the dose when Episenta granules are used in combination with other drugs. Your doctor will decide which dose is best for you. Always follow your doctor's instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the pack. If you do not understand, or are in any doubt ask your doctor or pharmacist.

You should continue to take Episenta prolonged-release granules for as long as your doctor tells you to.  Do not stop taking Episenta prolonged-release granules without consulting your doctor.

Episenta is  always to be taken by mouth, either before, with, or after meals, together with plenty of liquid, e.g. a full glass of water. The contents of the sachet may be sprinkled or stirred into soft food or drinks and swallowed immediately without chewing or crushing the prolonged-release granules. The food or drink should be cold or at room temperature. A mixture of the granules with liquid or soft food should not be stored for future use. If the contents of the sachet are taken in a drink, as some granules may stick to the glass after the drink has been finished, the glass should be rinsed with a small amount of water and this water swallowed as well. The prolonged-release granules should not be given in babies’ bottles as they can block the teat. The daily dosage should be given in one to two single doses.

The sachets of Episenta 500 mg and Episenta 1000 mg are torn open and the prolonged release granules poured out.

If you accidentally take too much Episenta contact your doctor or nearest hospital casualty department.  Take this leaflet and your prolonged-release granules to show the doctor.

If you forget to take a dose, take another as soon as you remember. If your next dose is due within 2 hours, take a single dose now and do not take the next dose. Never double up the next dose to make up for the one missed.

If your treatment with Episenta is stopped or switched to another type of anticonvulsant, this should be done gradually in order to maintain control of fits.

AFTER TAKING THIS MEDICINE.

Like many medicines Episenta may cause side effects in some patients, particularly when treatment is first started. Most common are stomach upsets. Less common are increased appetite and putting on weight, shakiness, drowsiness, unsteadiness, confusion, headache and a tendency for cuts to bleed longer than usual, or to bruise easily.  
Occasionally, patients experience skin rashes, or temporary loss of hair which may be curly on regrowth.  Liver problems and problems with the production of blood cells can occur (which is another reason for regular blood tests). In some cases laboratory examination of the blood might show changes in the liver function test, in the pancreatic function, in coagulation values or blood count.

If you suddenly become ill with vomiting, weakness, drowsiness, loss of appetite, unsteadiness and possibly jaundice (yellow skin), or if your fits occur more often tell your doctor immediately.

If you experience any other side effects or think that you may be reacting badly in any way, tell your doctor or pharmacist. 

There is a risk to the baby if anticonvulsants are taken during pregnancy. This has to be balanced against the risk to mother and baby of fits occurring during pregnancy, and needs to be discussed between you and your doctor.

Do not take Episenta prolonged-release granules if the expiry date on the label has passed or if they show signs of deterioration. These prolonged-release granules should be stored in the original sachets in which they were given to you. Do not transfer them to another container. Do not store above 30°C. Keep out of the sight and reach of children. 

REMEMBER, this medicine is for you only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep prolonged-release granules that you no longer need. Give them back to the pharmacist.

18 January 2007