ROSUVAST 5 MG 14 TAB

* ROSUVAST (Rosuvastatin) 5 mg 14 film-coated Tablets. Lipid Lowering Agent.
* Composition: Each film-coated tablet contains:
  Rosuvastatin Calcium 5.217 mg, equivalent to Rosuvastatin 5 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.