Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · CoAprovel

CoAprovel 300 mg/12.5 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 60

HOS-089474 · Präparat HOS-083831

Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone Investigations: Not known: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides Cardiac disorders: Not known: cardiac arrhythmias Blood and lymphatic system Not known: aplastic anaemia, bone marrow depression, disorders: neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia Nervous system disorders: Not known: vertigo, paraesthesia, light-headedness, restlessness Eye disorders: Not known: transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma, choroidal effusion Respiratory, thoracic and Very rare: acute respiratory distress syndrome (ARDS) mediastinal disorders: (see section 4.4) Not known: respiratory distress (including pneumonitis and pulmonary oedema) Gastrointestinal disorders: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite Renal and urinary disorders: Not known: interstitial nephritis, renal dysfunction Skin and subcutaneous tissue Not known: anaphylactic reactions, toxic epidermal disorders: necrolysis, necrotizing angiitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria Musculoskeletal and connective Not known: weakness, muscle spasm tissue disorders: Vascular disorders: Not known: postural hypotension General disorders and Not known: fever administration site conditions: Hepatobiliary disorders: Not known: jaundice (intrahepatic cholestatic jaundice) Psychiatric disorders: Not known: depression, sleep disturbances Neoplasms benign, malignant Not known: non-melanoma skin cancer (basal cell and unspecified (incl cysts and carcinoma and squamous cell carcinoma) polyps)

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