Patient leaflet - Ethosuximide Noumed 250 mg soft capsules
1. What Ethosuximide capsules are and what they are used for
Ethosuximide capsules contain ethosuximide which belongs to a group of medicines known as anticonvulsant agents. It is used to control epilepsy in children and adults. Epilepsy is a condition where you have repeated seizures (fits). This medicine is used to control brief, sudden loss of consciousness (absence seizures, also called petit mal) and uncontrolled jerking movements (myoclonic seizures).
How ethosuximide works exactly is unclear. It can be combined with other medicines for epilepsy.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Ethosuximide capsules
Do not take Ethosuximide capsules:
If you are allergic to ethosuximide, other succinimides (group of
medicines to which ethosuximide belongs) or any of the other ingredients of this medicine (listed in section 6).
- If the above applies to you, talk to your doctor or pharmacist. Warnings and precautions
Talk to your doctor or pharmacist before taking Ethosuximide capsules, if you:
- have liver or kidney disease
- are pregnant or planning a pregnancy, or if you are breast-feeding
- suffer from a different form of epilepsy. In this case, ethosuximide may trigger generalised seizures (seizures spread throughout the body)
- have bone marrow depression (decreased number of certain cells in the bone marrow) or a low blood platelet count
- are taking isoniazid, a medicine used for certain types of infections
- have a history of psychiatric illness.
Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with ethosuximide treatment. Stop taking Ethosuximide capsules and seek medical attention immediately if you notice any of the symptoms described in section 4.
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 bone marrow (inner part of the bone where blood cells are formed). Your liver enzymes should also be checked regularly.
A small number of people treated with anti- convulsant agents such as ethosuximide have also had thoughts about self-harm or suicide. If you have such thoughts at any time,contact your doctor immediately. If you experience movement disorders (see section 4) do not continue taking Ethosuximide capsules.
Please contact the nearest doctor who, in the event of significant disturbances, can administer diphenhydramine as an antidote if required
Other medicines and Ethosuximide capsules:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines known to affect the way ethosuximide works or known to be affected by ethosuximide:
other medicines for epilepsy (carbamazepine, primidone, lamotrigine,
phenobarbital, phenytoin, valproic acid)
- isoniazid (medicine for tuberculosis). The amount of ethosuximide in the blood may be increased
- sedatives that affect the nervous system.
Ethosuximide capsules with alcohol
If used at the same time, alcohol may have an adverse effect on the nervous system. The use of alcohol is therefore not recommended.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ethosuximide crosses the placenta. It is not clear whether the use of ethosuximide during pregnancy may be harmful. Ethosuximide has been shown to be harmful in animal trials. An increased risk of harm to the foetus has been reported with use of other medicines to treat epileptic seizures, especially when more than one medicine for epileptic seizures is used at the same time. Hence wherever possible, you should use only one medicine for epileptic seizures during pregnancy and only after consultation with your doctor.
Do not suddenly stop taking this medicine. This may lead to breakthrough seizures that could have serious consequences for you and your child. Tell your doctor immediately if you are pregnant, think you may be pregnant or are trying for a baby. The risk of taking ethosuximide must be weighed against the risk of seizures during pregnancy.
Breast-feeding
Ethosuximide passes into breast milk.
Side effects may occur in the infant, such as irritability, poor sucking reflex and drowsiness.
Breast-feeding during treatment with Ethosuximide capsules is therefore not recommended.
Driving and using machines
Ethosuximide can impair a patient’s reactivity and ability to react speedily and may cause side effects such as drowsiness or dizziness.
Therefore, the following should be considered throughout the treatment period and especially during any adjustments of dosage: you may not be able to respond quickly and purposefully to unexpected and sudden events; do not drive cars or other vehicles; do not operate dangerous electric tools or machines and do not work or perform any hazardous tasks without a secure hold.
The decision about whether you can drive and use machines will be taken in each case by your doctor considering your individual response to the medicine. Be advised that alcohol further impairs your driving capability. Ethosuximide soft capsules contains Sorbitol (E 420)
This medicine contains 9 mg of sorbitol per capsule.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
3. How to take Ethosuximide capsules
Always take this medicine exactly as your doctor has told you and always read the label.
Your doctor will decide on the appropriate dose to suit your condition. Check with 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
Unless otherwise prescribed by your doctor, the recommended dose is: Adults, elderly, and children over 6 years:
The usual starting dose is 2 capsules a day.
Your doctor may increase your dose by 250 mg (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.
The risk of side effects which depend on the dose taken can be reduced by taking small initial doses of Ethosuximide capsules and increasing them gradually to optimum amounts (increasing the amounts slowly from day to day) and by taking them during or after meals.
Use in children under 6 years
Children under 6 years and those unable to swallow capsules will be given ethosuximide in liquid form.
LETHSC01/02 Blood tests may be carried out to check the level of ethosuximide in your body.
If you take more Ethosuximide capsules 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.
Do this even if you feel well.
If you forget to take Ethosuximide capsules
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 the forgotten dose.
If you stop taking Ethosuximide capsules
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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.
reddish patches on the trunk, the patches are target-like macules or circular,
often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
widespread rash, high body temperature and enlarged lymph nodes
(drug reaction with eosinophilia and systemic symptoms (DRESS)). 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.
Very common (may affect more than 1 in 10 people):
- hiccups
- nausea, vomiting,
- abdominal pain
Uncommon (may affect up to 1 in 100 people):
- weight loss, disturbance in appetite
- social withdrawal, anxiety, sleep disturbances
- diarrhoea, constipation
- severe headache, ataxia (inability to coordinate muscle movements), lethargy.
Rare (may affect up to 1 in 1000 people):
- nephrotic syndrome (a kidney disorder which causes the leaking of protein into the urine)
- skin rash, erythema nodosum, Stevens-Johnson syndrome
- systemic lupus erythematosus (SLE)
- agranulocytosis (very low levels of a type of white blood cell called granulocytes, which are important for fighting off infection)
- eosinophilia (an excess of eosinophils, a type of white blood cell)
- leukopenia low level of white blood cells
- paranoid or hallucinatory manifestations.
Not known (frequency cannot be estimated from the available data):
- peripheral blood count abnormalities (slight decrease in leukocytes)
aplastic anaemia (when bone marrow stops producing new blood cells
causing tiredness, lower ability to fight infection and uncontrolled
bleeding)
- pancytopenia (low levels of all types of blood cells including platelets)
- neutrophilia (high levels of a type of white blood cell called neutrophils)
- monocytosis (high levels of a type of white blood cell called monocytes)
- states of agitation
- depression
- psychological changes, psychoses
- increased libido
- euphoria
- dyskinesia (difficulty controlling movement)
- photophobia
- dizziness
- drowsiness
- behavioural disorders
- fatigue
- hyperactivity
- myopia (near sightedness or short-sightedness)
- gastrointestinal disorder
- gum hypertrophy (excessive growth of the gums)
- swelling of the tongue
- vaginal bleeding
- irritability
- night terrors
- inability to concentrate
- aggressiveness
- changes in your blood (bruising or bleeding more easily, fever, sore throat, mouth ulcers, fatigue, repeated infections or infections that will not go away). Your doctor may take regular blood samples to test for these effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5. How to store Ethosuximide capsules
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the label/blister. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Ethosuximide capsules contain
The active substance is Ethosuximide.
Each capsule contains 250 mg of ethosuximide.
The other ingredients of capsule shell are gelatin, glycerol and sorbitol liquid partially dehydrated (E 420).
The capsule fill contains macrogol.
What Ethosuximide capsules looks like and contents of the pack
Ethosuximide capsules are oval shape, soft gelatin capsules filled with semi-transparent liquid.
Available in PVC/PE/PVDC/Al blister packs containing 50, 56, 100 and 200 soft capsules.
Not all pack sizes may be marketed.
This leaflet was last revised in December 2025.
Marketing Authorisation Holder and Manufacturer
Noumed Life Sciences Limited
Noumed House, Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, UK
Other sources of information:
To listen to or request a copy of this leaflet in braille, large print or audio please call, 020 33998960 (UK only). Please be ready to give the following information:
Product name:
Ethosuximide Noumed 250 mg soft capsules
Reference number: PL 44041/0179
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