Contraindications : התוויות נגד

4.3   Contraindications

•    Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
•    Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures (see section 4.6).
•    Active liver disease or unexplained persistent elevations in serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN) (see section 4.4).
•    In patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
•    In patients with myopathy (see section 4.4).
•    In patients receiving concomitant ciclosporin (see section 4.5).

The 40 mg / 10 mg dose 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 sections 4.4, 4.5 and 5.2)