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Fenofibrate/Simvastatin (Cholib) 145 mg/20 mg and Fenofibrate/Simvastatin (Cholib) 145 mg/40 mg: Hypersensitivity to the active substances, peanut, soya (see Precautions).
Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
Active liver disease or unexplained persistent elevations of serum transaminases.
Known gallbladder disease.
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
Moderate to severe renal insufficiency (estimated glomerular filtration rate <60 mL/min/1.73 m2).
Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome P450 (CYP) 3A4 inhibitors (see Interactions).
Concomitant administration of glecaprevir/pibrentasvir (see Interactions).
Pediatric population (age below 18 years).
Pregnancy and breast-feeding (see Use in Pregnancy & Lactation).
Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see Precautions).
Fenofibrate/Simvastatin (Cholib) 145 mg/40 mg only: Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see Interactions).
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