ETHOSUXIMIDE NOUMED

Posology Adults, elderly, and children over 6 years Start with a small dose – 500 mg daily with increments of 250 mg every five to seven days, depending on the patient’s tolerance until control is achieved with 1000– 1500 mg daily.

Occasionally 2000 mg in divided doses may be necessary. Children between 0-6 years Children aged 0-6 years old and those who are unable to swallow capsules should be given ethosuximide oral liquid. 1. Effective plasma levels of ethosuximide normally lie between 40 and 100 μg/ml.

but the clinical response should be the criteria for the regulation of the dosage. The half- life of ethosuximide in the plasma is more than 24 hours but the daily dose if large is more comfortably divided between morning and evening.

The probability of dose-dependent undesirable effects can be reduced by careful dosing (small initial dose at the start of treatment, gradual increase of dose) and by taking the medicinal product during or after meals. Anti-epileptic therapies are principally long-term therapies.

A specialist (neurologist, neuropaediatrician) should decide about the start, duration, and discontinuation of ethosuximide on an individual basis. In general, reduction of the dose and discontinuation of the medicinal product should not be considered before the patient has been free from fits for 2-3 years.

The medicinal product must be discontinued by reducing the dose gradually over a period of one to two years. Children may be allowed to outgrow the dose per kg body weight instead of adjusting the dose according to their age, however, it must be ensured that the EEC findings do not deteriorate.

Use with caution in hepatic or renal impairment. Monitor liver/renal function and ethosuximide concentrations. Method of administration Ethosuximide Noumed 250 mg soft capsules are for oral use. The soft capsules can be taken during or after meals with some liquid.

The frequency of possible undesirable effects is defined using the following convention: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (> 1/1,000 to < /100) Rare (> 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Undesirable effects in the therapeutic dose range are common and are observed in approximately 1 in 6 patients.

The majority involve nausea, vomiting, singultus and abdominal pain.

Blood and lymphatic system disorders Rare:

Leukocytopenia*, agranulocytosis*, eosinophilia* Not known: Aplastic anaemia*, thrombocytopenia*,pancytopenia*, neutrophilia and monocytosis have been reported Immune system disorders Rare Nephrotic syndrome Metabolism and nutrition disorders Uncommon: weight loss, appetite disturbances Psychiatric disorders Uncommon: Social Withdrawal, anxiety, sleep disturbances Rare: Paranoid/hallucinatory manifestations developing within days or weeks.

Not known Psychological changes (psychoses), states of agitation, depression, increased libido Nervous system disorders Uncommon: Severe headache, ataxia, lethargy Not known: Euphoria, dyskinesia, photophobia, dizziness**, drowsiness, behavioural disorders, fatigue, hyperactivity.

4) **In combined forms of epilepsy and also in combination with other anticonvulsant agents, 20- 30% experienced nausea, vomiting, headache, dizziness. In most cases of leucopenia, the blood picture has returned to normal on reduction of dose or discontinuation.

In some instances, patients who become leucopenic on other anticonvulsant therapy have been satisfactorily treated with ethosuximide alone. Patients should be advised to seek immediate medical attention for full blood count tests if symptoms such as fever, sore throat, mouth ulcers, bruising or bleeding develop.

Ethosuximide when used alone in mixed types of epilepsy may increase the frequency of generalised tonic-clonic (grand mal) seizures in some patients. g. the nephrotic syndrome generally with complete recovery on drug withdrawal, to the detection of antinuclear antibodies without clinical features.

4). As a rule, adverse reactions resolve when the dosage is reduced. Usually, they do not recur upon subsequent dose escalation. In the event of undesirable effects that are reversible and not dose dependent, discontinuation of ethosuximide is indicated.

They may be expected to recur on rechallenge. g. a reduction in academic achievement in children and adolescents. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Suicidal ideation and behaviour Suicidal ideation and behaviour has been reported in patients treated with anti- convulsants in various indications. A meta-analysis of randomised, placebo- controlled studies with anticonvulsants also reveals a slight increase in the risk of suicidal ideation and behaviour.

The mechanism behind this risk is not known, and the available data do not exclude the possibility of an increased risk for ethosuximide. Patients must therefore be closely monitored for signs of suicidal ideation and behaviour, and appropriate treatment should be considered.

Patients (and their carers) must be advised that, if signs of suicidal ideation or behaviour occur, medical advice must be sought. In patients with combined forms of epilepsy, ethosuximide can induce generalised seizures. When switching from existing medication to ethosuximide or when discontinuing ethosuximide, this should be done gradually.

8), ethosuximide must be discontinued and diphenhydramine administered by the intravenous route, if required. Ethosuximide Noumed 250 mg soft capsules should always be withdrawn slowly. Regular monitoring of the blood count is recommended, especially in patients with hepatic or renal dysfunction, as bone marrow depression and thrombocytopenia may occur (including some cases with fatal outcome).

Periodic blood tests should be performed. Severe skin reactions Serious dermatologic reactions, including Stevens-Johnson Syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with ethosuximide treatment.

SJS and DRESS can be fatal. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Ethosuximide should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

8, paranoid/hallucinatory symptoms, anxiety states, agitation), and therefore special caution must be exercised when ethosuximide is used in this group of patients. 8). It is recommended to check the blood count regularly (initially monthly, after one year every six months) to identify potential bone marrow damage.

At a leucocyte count of less than 3500/mm³ or a granulocyte ratio of less than 25%, the dose should be reduced or the therapy discontinued. The liver enzymes should also be checked regularly. Ethosuximide contains sorbitol (E 420). This medicine contains 9 mg of sorbitol per capsule.

Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

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