WHAT YOU SHOULD KNOW ABOUT EMESIDE CAPSULES

Please read this leaflet carefully. If you have any questions or are not sure about this medicine you should ask your doctor or pharmacist.
Active constituent: Ethosuximide 250 mg.

Other constituents are Polyethylene Glycol 400, Gelatine, Glycerine (E 422), Ethyl p-hydroxybenzoate (E 214), Propyl p-hydroxybenzoate (E 216), Titanium Dioxide (E 171), Sunset Yellow (E 110).

The Product licence holder is:
Laboratories for Applied Biology Limited
91 Amhurst Park London,
England N16 5DR.
PL 0118/5002R

The capsules are manufactured under contract to L.A.B.Ltd by:
R P Scherer Ltd,
Swindon,
SN 5 8 YS,
UK ML 0334/01

PRESENTATION Plastic tube containing 112 soft orange gelatine capsules, each containing 250mg of Ethosuximide BP.

EMESIDE is a brand of ethosuximide, a type of anti-epileptic drug used for the treatment of minor seizures or absences, also called petit mal, and also for the treatment of myoclonic seizures.

IS IT SAFE FOR YOU TO USE EMESIDE CAPSULES?

Before taking the capsules: if you have ever reacted badly to anti-epileptics, or to any of the ingredients listed above, if you have liver or kidney disease, or if you have porphyria, or if you are pregnant or planning a pregnancy, or if you are breastfeeding, or if are you taking carbamazepine, phenytoin, sodium valproate, isoniazid, or other medicines for epilepsy, then tell your doctor or pharmacist.

If too much of the medicine is taken than marked drowsiness or confusion occurs. This medicine may affect your abiility to drive or use machinery.

HOW TO TAKE YOUR MEDICINE

It is important to take the capsules at the right time and regularly; the label will tell you how many to take at one time. The normal dose for adults and children over six years is two capsules a day to start with, increasing by one capsule a day every five to seven days until control is achieved, up to a maximum of eight capsules a day. Children under six years will normally be given ethosuximide in a liquid form. Do not change the dose yourself. If you forget to take the dose take it as soon as you remember, but if it is almost time for the next dose, skip the missed dose and continue as usual. DO NOT take double the dose. Do not stop taking the medicine without telling your doctor, who will advise you how gradually this must be done. Your doctor may wish to perform blood tests to monitor blood levels. If you take an overdose tell your doctor immediately; otherwise go to your nearest hospital emergency department, taking the Emeside container with you.

ARE THERE ANY SIDE EFFECTS?

It is common to have a feeling of sickness, vomiting, distaste for food or stomachache at first but these effects generally settle without changing the dose. It is less common to have headache, tiredness, drowsiness, dizziness, unusual limb movements, hiccough, dislike of bright light, lack of interest, depression, euphoria or skin rash. Other adverse reactions reported include: weight loss, diarrhoea, abdominal pain, gum hypertrophy, swelling of the tongue, hiccoughs, irritability, hyperactivity, sleep disturbances, night terrors, inability to concentrate, aggressiveness, paranoid psychosis, increased libido, myopia, and vaginal bleeding. Very rarely, serious disorders occur reducing the number of blood cells or platelets. Seek immediate medical attention if symptoms such as fever, sore throat, mouth ulcers, bruising or bleeding occur. Likewise, if you find you are unable to fight off infections, see your doctor immediately. A general reaction affecting many of the body organs, called a Lupus-like reaction has been reported in children; there may be fever, rash, painful joints, or kidney inflammation. Your doctor may wish to perform blood or urine tests. Any side effects that you feel may be caused by the medicine should be reported to your doctor or pharmacist. If anything worries you ask your doctor.

STORING THE MEDICINE

Keep the bottle of capsules in a safe place out of the reach of children or adults who may not understand that they could be harmful. Keep the bottle of capsules at below 30 C (room temperature in the UK) away from moisture. Do not refrigerate. If your doctor decides to stop the treatment, return all the unused capsules in the bottle to the pharmacist. Do not use if the expiry date has passed.

REMEMBER: this medicine is only for you; it can only be prescribed by a doctor. Never give the medicine to someone else.

This document was prepared in July 2001.