Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zyprexa

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

HOS-085974 · Präparat HOS-083234

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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