ETHOSUXIMIDE TILLOMED

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 to 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 mcg per 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 Tillomed 250 mg soft capsules is for oral use. The capsules can be taken during or after meals with some liquid.

4). 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 < 1/100) Rare (> 1/10,000 to < 1/1000) Very rare (<1/10,000) Not known (frequency cannot be estimated from the available data).

System organ class Very common Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Peripheral blood count abnormalities (slight decrease in leukocytes). Aplastic anaemia, agranulocytosis, pancytopenia, neutrophilia, Monocytosis, eosinophilia and leukopenia have been reported, thrombocytopenia Immune system disorders Nephrotic syndrome Psychiatric disorders Psychological changes (psychoses), states of agitation, depression, paranoid psychoses, sleep disturbances, increased libido Nervous system disorders Apathy, euphoria, ataxia, dyskinesia, photophobia, headache*, dizziness*, drowsiness, anorexia, behavioural disorders, fatigue, hyperactivity Eye disorders Myopia Gastrointestin al disorders Nausea, vomiting*, diarrhoea, abdominal pain, gum hypertrophy, swelling of the tongue Skin and subcutaneous tissue disorders Skin rash, erythema nodosum, Stevens-Johnson syndrome Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskelet al and connective tissue disorders Systemic lupus erythematosus (SLE) Reproductive system and breast disorders Vaginal bleeding General disorders and administration site conditions Weight loss, hiccoughs, irritability, night terrors, inability to concentrate, aggressiveness *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.

Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported to occur in patients treated with anticonvulsants in various indications. A meta-analysis of randomized, placebo- controlled studies with anticonvulsants also reveals a slight increase in the risk of suicidal ideation and suicidal behaviour.

The mechanism behind this risk is not known and the available data do not exclude the possibility of an increased risk for ethosuximide. Patient 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 may be administered, if required. Ethosuximide Tillomed 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.

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