Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Duloxetine Zentiva

Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules · Abschnitt 4.8 · PDF-Seite 11–13

HOS-133028 · Präparat HOS-097350

11 Very common Common Uncommon Rare Very Not known rare Gastrointestinal disorders Nausea Constipation Gastrointestinal Stomatitis Dry mouth Diarrhoea haemorrhage7 Haematochezi Abdominal Gastroenteritis a pain Eructation Breath odour Vomiting Gastritis Microscopic Dyspepsia Dysphagia colitis9 Flatulence Hepato-biliary disorders Hepatitis3 Hepatic Elevated liver failure6 enzymes (ALT, Jaundice6 AST, alkaline phosphatase) Acute liver injury Skin and subcutaneous tissue disorders Sweating Night sweats Stevens- Cutaneo increased Urticaria Johnson us Rash Dermatitis Syndrome6 vasculiti contact Angio- s Cold sweat neurotic Photo- oedema6 sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo- Muscle Trismus skeletal pain tightness Muscle spasm Muscle twitching Renal and urinary disorders Dysuria Urinary Urine odour Pollakiuria retention abnormal Urinary hesitation Nocturia Polyuria Urine flow decreased Reproductive system and breast disorders Erectile Gynaecological Menopausal dysfunction haemorrhage symptoms Ejaculation Menstrual Galactorrhoea disorder disorder Hyperprolactin Ejaculation Sexual aemia delayed dysfunction Postpartum Testicular pain haemorrhage6 General disorders and administration site conditions Falls8 Chest pain7 Fatigue Feeling abnormal Feeling cold 12 Very common Common Uncommon Rare Very Not known rare Thirst Chills Malaise Feeling hot Gait disturbance Investigations Weight Weight Blood decrease increase cholesterol Blood creatine increased phosphokinase increased Blood potassium increased 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation. 2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment. 3 See section 4.4. 4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation. 5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4). 6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo- controlled clinical trials. 7 Not statistically significantly different from placebo. 8 Falls were more common LQWKHHOGHUO\ • 65 years old) 9 Estimated frequency based on all clinical trial data. 10 Estimated frequency based on placebo-controlled clinical trials.

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