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 8–10

HOS-209076 · Präparat HOS-154237

8  levels2,3 diabetes Elevated glucose occasionally levels4 associated with Elevated ketoacidosis or triglyceride coma, including levels2,5 some fatal cases Glucosuria (see section 4.4)11 Increased appetite Nervous system disorders Somnolence Dizziness Seizures where in Neuroleptic Akathisia6 most cases a malignant Parkinsonism6 history of seizures syndrome (see Dyskinesia6 or risk factors for section 4.4)12 seizures were Discontinuation reported11 symptoms7,12 Dystonia (including oculogyration)11 Tardive dyskinesia11 Amnesia9 Dysarthria Stuttering11 Restless legs syndrome11 Cardiac disorders Bradycardia Ventricular QTc prolongation tachycardia/fibrill (see section 4.4) ation, sudden death (see section 4.4)11 Vascular disorders Orthostatic Thromboembolis hypotension10 m (including pulmonary embolism and deep vein thrombosis) (see section 4.4) Respiratory, thoracic and mediastinal disorders Epistaxis9 Gastrointestinal disorders Mild, transient Abdominal Pancreatitis11 anticholinergic distension9 effects including Salivary constipation and hypersecretion11 dry mouth Hepatobiliary disorders Transient, Hepatitis asymptomatic (including elevations of hepatocellular, hepatic cholestatic or aminotransferases mixed liver (ALT, AST), injury)11 especially in early treatment (see section 4.4) 9 Skin and subcutaneous tissue disorders Rash Photosensitivity Drug Reaction reaction with Eosinophilia Alopecia and Systemic Symptoms (DRESS) Musculoskeletal and connective tissue disorders Arthralgia9 Rhabdomyolysis11 Renal and urinary disorders Urinary incontinence Urinary retention Urinary hesitation11 Pregnancy, puerperium and perinatal conditions Drug withdrawal syndrome neonatal (see section 4.6) Reproductive system and breast disorders Erectile Amenorrhea Priapism12 dysfunction in Breast males enlargement Decreased libido Galactorrhea in in males and females females Gynaecomastia/br east enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10 Investigations Elevated plasma Increased alkaline Increased total prolactin levels8 phosphatase10 bilirubin High creatine phosphokinase11 High Gamma Glutamyltransfera se10 High uric acid10 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Following short term treatment (median duration 47 days), weight gain ≥7% of baseline body weight was very common (22.2%), ≥15% was common (4.2%) and ≥25% was uncommon (0.8%). Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4%, 31.7% and 12.3% respectively). 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 3 Observed for fasting normal levels at baseline (<5.17 mmol/l) which increased to high (≥6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline (≥5.17-<6.2 mmol/l) to high (≥6.2 mmol/l) were very common.

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