Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Olanzapine Teva

Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12

HOS-209086 · Präparat HOS-154237

Metabolism and nutrition disorders Very common: Weight gain13, elevated triglyceride levels14, increased appetite. Common: Elevated cholesterol levels15 Nervous system disorders Very common: Sedation (including: hypersomnia, lethargy, somnolence). Gastrointestinal disorders Common: Dry mouth Hepatobiliary disorders Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). Investigations Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16. 13 Following short term treatment (median duration 22 days), weight gain ≥7% of baseline body weight (kg) was very common (40.6%), ≥15% of baseline body weight was common (7.1%) and ≥25% was common (2.5%). With long-term exposure (at least 24 weeks), 89.4% gained ≥7%, 55.3%gained ≥15% and 29.1% gained ≥25% of their baseline body weight. 14 Observed for fasting normal levels at baseline (<1.016 mmol/l) which increased to high (≥1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l-<1.467 mmol/l) to high (≥1.467 mmol/l). 15 Changes in total fasting cholesterol levels from normal at baseline (<4.39 mmol/l) to high (≥5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (≥4.39-<5.17 mmol/l) to high (≥5.17 mmol/l) were very common. 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.

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