Rosuvastatin Tablets are contraindicated: Patients with hypersensitivity to the active substance or any of the excipients listed in Description; Patients with active liver disease including unexplained, persistent elevation of serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN); Patients with severe renal impairment; Patients with myopathy; Patients receiving concomitant ciclosporin; During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measure.
The 40 mg dose is contraindicated in patients with pre-deposing factors for myopathy/rhabdomyolysis. Such factors include: Moderate renal impairment; 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 when an increase in plasma levels may occur; Asian patients; Concomitant use of fibrates; The concomitant use with protease inhibitors is not recommended.