Ethosuximide Essential Generics 250 mg Capsules

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Throughout this leaflet Ethosuximide Essential Generics 250 mg Capsules will be referred to as ‘Ethosuximide capsules.’

1. What Ethosuximide capsules are and what they are used for
2. What you need to know before you take Ethosuximide capsules
3. How to take Ethosuximide capsules
4. Possible side effects
5. How to store Ethosuximide capsules
6. Contents of the pack and other information

• if you are allergic to ethosuximide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to soya oil (see end of this section).
• if you 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.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Ethosuximide Capsule treatment. Stop using Ethosuximide Capsules and seek medical attention immediately if you notice any of the symptoms described in section 4. These symptoms often occur within 28 days of starting this medicine, but can happen later.

Talk to your doctor or pharmacist before taking Ethosuximide capsules if you suffer or have suffered in the past from any of the following conditions:

• Liver disease
• Kidney disease
• Bruising, fever, looking pale or a severe sore throat. These may be the first signs of a potentially serious blood disorder, which could be fatal if not detected.

Your doctor may take regular blood and/or urine samples to test for these.

Pay special attention to symptoms of bone marrow depression such as fever, inflammation of throat or pharynx tonsils as well as haemorrhagic tendency, and consult your doctor, if you experience any of these symptoms.

Your blood count should be checked regularly (initially monthly, after one year every six months) to identify potential injury of the medulla. Your liver enzymes should also be checked regularly.

If you are taking anti-epileptic drugs, your doctor will routinely assess you for depression, anxiety and suicidality. If you are taking anti-epileptic drugs and you feel depressed and anxious, the symptoms of which are feeling low, loss of interest in everyday activities, lack of energy and a general feeling of unease, please consult your doctor.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may be affected by ethosuximide or they may affect how well ethosuximide will work. Tell your doctor or pharmacist if you are taking:

• isoniazid, a medicine used for certain types of infections
• other medicines used for epilepsy, in particular phenytoin, sodium valproate and valproic acid.

If Ethosuximide capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.

Your doctor may need to test the amount of these medicines in your blood to help decide if any of these medicines are affecting your treatment.

Ethosuximide capsules can be taken before or after food and drink.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take Ethosuximide capsules if you are breast-feeding.

Ethosuximide capsules may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery.

• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate

This medicine contains sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

• soya

This medicine also contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free.’

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.

Use in children under 6 years

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 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 a dose take it as soon as you remember, but if it is almost time for your next dose, skip the forgotten dose and continue as usual.

Do not take a double dose to make up for a forgotten dose.

Do not stop taking Ethosuximide Capsules unless your doctor tells you to. If you suddenly stop taking this medicine you may have a seizure. Should you need to stop taking Ethosuximide Capsules, your doctor will decide which method is best for you.

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 medicine, ask your doctor or pharmacist.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is ethosuximide. Each capsule contains 250 mg ethosuximide.
• The other ingredients are macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate (E215), sodium propyl hydroxybenzoate (E217), miglycol 812 (fractionated coconut oil), soya lecithin. (See end of Section 2 for further information on sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin).

Ethosuximide 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.

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