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Hypersensitivity to the active substances or to any of the excipients.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and nursing (see Use in Pregnancy & Lactation).
When Ezetimibe/Simvastatin (VYTORIN) is to be administered with fenofibrate, refer to the Package Insert for fenofibrate.
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin nefazodone, and drugs containing cobicistat) (see Myopathy/Rhabdomyolysis under Precautions and Interactions).
Concomitant administration of gemfibrozil, cyclosporine, or danazol (see Myopathy/Rhabdomyolysis under Precautions and Interactions).
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