Nebenwirkungen · Inovelon
Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-115259 · Präparat HOS-094253
The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide. The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence. The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting. Adverse reactions were usually mild to moderate in severity. The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
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