Ethosuximide Essential Generics 250mg Capsules
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Ethosuximide
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine is and what it is used for
Emeside Capsules contain ethosuximide which is an anti-epileptic.
It is used to control epilepsy in children and adults.
Epilepsy is a condition where you have repeated seizures (fits).
Ethosuximide is used to control brief, sudden loss of consciousness (absence seizures, also called petit mal), and uncontrolled jerking movements (myoclonic seizures).
2. Before you take
Do NOT take Emeside Capsules if you:
• are allergic to ethosuximide, other similar medicines called succinimides, or to any of the other ingredients (see Section 6)
• have porphyria (a metabolism disorder which causes abdominal pains and mental disorder).
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Emeside Capsules
Before taking the capsules, tell your doctor if you:
• have liver or kidney disease
• are pregnant or planning a pregnancy, or if you are breast-feeding.
A small number of people being treated with anti-epileptics such as ethosuximide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Emeside Capsules or they may affect how well Emeside Capsules will work. Tell your doctor or pharmacist if you are taking:
• isoniazid , a medicine used for certain types of infections
• other medicines to control epilepsy, in particular carbamazepine, phenytoin, sodium valproate. If Emeside Capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.
Pregnancy and breast-feeding
Ethosuximide may affect the unborn baby.
However, it is very important to control your fits while you are pregnant.
If you need to take ethosuximide, your doctor can help you decide whether or not to take it during pregnancy.
DO NOT take Emeside Capsules if you are breast-feeding, as it can pass into breast milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Emeside Capsules may cause drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.
Important information about some of the ingredients of Emeside Capsules
• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate
These may cause allergic reactions (possibly delayed).
3. How to take
Always take Emeside Capsules exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• It is important to take the medicine at the right time and regularly, as directed by your doctor.
• Swallow the capsules whole with a drink of water.
• Take the capsules with or without food, whichever you prefer.
Doses
Adults, elderly and children over 6 years: the usual starting dose is 2 capsules a day. Your doctor may increase your dose by 1 capsule a day every 5 to 7 days until your epilepsy is well controlled.
A maximum dose of 8 capsules a day, taken in divided doses, may occasionally be necessary.
Do NOT change the dose yourself.
Children under 6 years and those unable to swallow capsules: will be given ethosuximide in liquid form.
Blood tests may be carried out to check the level of ethosuximide in your body.
If you take more than you should
If you take more capsules than you should you may feel very drowsy or confused.
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the container and any remaining capsules with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not use a double dose to make up for a missed dose.
If you stop taking
Stopping this medicine suddenly may make your seizures worse. The doctor will advise you how to stop the medicine gradually. Keep taking this medicine for as long as the doctor tells you to.
Ethosuximide helps to control your condition, but does not cure it. Therefore you must take your medicine every day, even if you feel well.
Do not let yourself run out of medicine, especially over the weekend or on holidays.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Emeside Capsules can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the capsules and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
• fever, sore throat, mouth ulcers, bruising or bleeding, repeated infections or infections that will not go away. This may be due to changes in your blood. Blood tests may be carried out to test for this.
• increased seizures (fits). Blood tests may be carried out and your doctor may adjust the dose
• fever, rash, painful joints, or kidney inflammation (you may not be able to feel this) which is a general reaction affecting many of the body organs, called a Lupus-like reaction reported in children. Your doctor may wish to perform repeated blood or urine tests.
Tell your doctor if you get any of the following side effects:
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
• swelling of the tongue
• irritability
• hyperactivity
• sleep disturbances, night terrors
• inability to concentrate
• aggressiveness
• feeling paranoid or suspicious
• increased sexual drive
• short-sightedness
• vaginal bleeding.
The following side effects usually settle without changing the dose:
• nausea, vomiting, distaste for food, anorexia or stomach ache
• feeling of extreme happiness, irritability or excitement
• lack of emotion or interest
• depression
• feeling tired or drowsy
• headache
• unusual limb movements, problems with body co-ordination
• dislike of bright light.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month.
• Store below 30°C away from moisture. Do not refrigerate.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Emeside Capsules contain
• The active ingredient is ethosuximide (250 mg).
• The other ingredients are:
macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate (E215), sodium propyl hydroxybenzoate (E217), fractionated coconut oil, soya lecithin.
(See end of Section 2 for further information on sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate).
What Emeside Capsules look like and contents of the pack
Emeside Capsules are clear oval soft gelatin capsules.
They are available in packs of 56, 112 or 500 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder
Chemidex Pharma Ltd., Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Catalent France Beinheim S.A., 74 rue Principale, 67930 Beinheim, France.
This leaflet was last revised in
March 2014
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