Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Cholib

Cholib 145 mg/40 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 34–35

HOS-127073 · Präparat HOS-096355

34 System Organ Class Adverse reactions Adverse reactions Frequenc (fenofibrate) (simvastatin) y Vascular disorders Thromboembolism uncommo (pulmonary embolism, n deep vein thrombosis)* Respiratory, thoracic and Interstitial lung disease not mediastinal disorders known Gastrointestinal Gastrointestinal signs and common disorders symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence) Pancreatitis* uncommo n Constipation, dyspepsia rare Hepatobiliary disorders Transaminases increased common Cholelithiasis uncommo n Complications of not cholelithiasis (e.g. known cholecystitis, cholangitis, biliary colic etc) Gamma-glutamyltransferas rare e increase Hepatitis/jaundice very rare Hepatic failure Skin and subcutaneous Severe cutaneous reactions not tissue disorders (e.g erythema multiforme, known Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.) Cutaneous hypersensitivity uncommo (e.g. Rash, pruritus, n urticaria) Alopecia rare Photosensitivity reactions rare Hypersensitivity syndrome rare *** Lichenoid drug eruptions very rare Musculoskeletal, Muscle disorders (e.g. uncommo connective tissue myalgia, myositis, n disorders muscular spasms and weakness) Rhabdomyolysis with or rare without renal failure (see section 4.4), Myopathy** rare Immune-mediated necrotizing myopathy (see section 4.4) Tendinopathy unkown

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