Hypersensitivity to the active substances or to any of the excipients listed in Description.
Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures (see Use in Pregnancy & Lactation).
Active liver disease or unexplained persistent elevations in serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN) (see Precautions).
In patients with severe renal impairment (creatinine clearance <30 mL/min) (see Precautions).
In patients with myopathy (see Precautions).
In patients receiving concomitant ciclosporin (see Interactions).
The Rosuvastatin/Ezetimibe (Zenon) 40 mg/10 mg dose (not available in the Philippines) is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include: Moderate renal impairment (creatinine clearance <60 mL/min).
Hypothyroidism.
Personal or family history of hereditary muscular disorders.
Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate.
Alcohol abuse.
Situations where an increase in plasma levels of rosuvastatin may occur.
Asian patients.
Concomitant use of fibrates.
(See Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions.)
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