Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vimpat

Treatment initiation pack (in adolescents and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets Vimpat 100 mg film-coated tablets Vimpat 150 mg film-coated tablets Vimpat 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 29

HOS-119488 · Präparat HOS-094947

The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (PGTCS) was consistent with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset seizures. Additional adverse reactions reported in PGTCS patients were myoclonic epilepsy (2.5 % in the lacosamide-group and 0 % in the placebo-group) and ataxia (3.3 % in the lacosamide-group and 0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy were dizziness and suicidal ideation. The discontinuation rate due to adverse reactions was 9.1 % in the lacosamide group and 4.1 % in the placebo group.

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