Rovastin-BP

Rosuvastatinum

Rovastin-BP 10 mg film-coated tablets: Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: lactose monohydrate 90.00 mg.

Rovastin-BP 20 mg film-coated tablets: Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: lactose monohydrate 180.00 mg.

Indication: Treatment of hypercholesterolaemia: Adults, adolescents and children aged 6 years and older with primary hypercholesterolaemia (type IIa, including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb), as an adjunct to diet when the response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Adults, adolescents and children aged 6 years and older with homozygous familial hypercholesterolaemia, as an adjunct to diet and other lipid-lowering treatments (e.g. LDL apheresis) or where such treatments are not appropriate. Prevention of cardiovascular events: prevention of major cardiovascular events in patients at high risk of a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.

Rovastin-BP is contraindicated: − in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − in patients with active liver disease, including unexplained persistent elevations of plasma transaminases and any elevation of plasma transaminases exceeding 3 times the upper limit of normal (ULN) − in patients with severe renal impairment (creatinine clearance