Nebenwirkungen · Lyrica
Lyrica 20 mg/mL oral solution · Abschnitt 4.8 · PDF-Seite 28
HOS-112933 · Präparat HOS-093785
Paediatric population The pregabalin safety profile observed in five paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; pharmacokinetic and tolerability study, n=65; and two 1 year open label follow on safety studies, n=54 and n=431) was similar to that observed in the adult studies of patients with epilepsy. The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis. The most common adverse events observed in the 14-day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2).
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Version 2026-10-13T14:23:00Z · SHA-256 b911bddbab432f8a0fcedb9c67537bff55e0bf53d314c31c88869bca834605af · Passage 876155387d5e2faf94b7cbcd44dd476044d1cffff4ed8ec43a6d47e99c63203f · Zeichen 7907–8818 im Abschnitt