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It is contraindicated in the following conditions: Patients with a known hypersensitivity to any component of this product.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Patients with myopathy.
Patients receiving concomitant cyclosporine.
Patients with severe renal impairment (creatinine clearance <30 ml/min).
During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
The 40 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 may occur; Asian patients; Concomitant use of fibrates.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
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