* ROSUVAST (Rosuvastatin) 10 mg 14 film-coated Tablets. Lipid Lowering Agent.* Composition: Each film-coated tablet contains: Rosuvastatin Calcium 10.434 mg, equivalent to Rosuvastatin 10 mg.* Indications: – Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia), or mixed dyslipidaemia (type IIb), as adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. – Homozygous familial hypercholesterolemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL aphaeresis) or if such treatments are not appropriate.* Dosage & Administration: – The patient should be placed on a standard cholesterol-lowering diet before receiving Rosuvast and should continue on this diet treatment during treatment. The dose should be individualized according to the goal of therapy and patient response. – The recommended starting dose is 5 mg or 10 mg once daily. – If necessary the dose may be increased, at intervals of at least 4 weeks to 20 mg once daily, increased to 40 mg daily only in severe hypercholesterolemia with high cardiovascular risk and under specialist supervision; ELDERLY initially 5 mg once daily. – Dosage in hepatic impairment: No dosage adjustment in patients with mild to moderate hepatic impairment. Rosuvast is not recommended in patients with severe liver dysfunction. – Dosage in renal impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. The use of Rosuvast in patients with severe renal impairment is contraindicated. – Co-administration with other medicines: The 40 mg dose is contraindicated with concomitant use of a fibrate. Rosuvast is neither an inhibitor non an inducer of cytochrome P450 isoenzymes.* Contraindications: – Hypersensitivity to the active substances or to any of the excipients. – Active liver disease or unexplained persistent elevations of serum transaminases. – Severe renal impairment. – Pregnancy and lactation.* Store in a dry place, at a temperature not exceeding 30 degrees C.* Produced by: Chemipharm Pharmaceutical Industries S.A.E. – Egypt.