COMPOSITION

Each film-coated tablet contains:

Rosuvastatin Calcium equivalent to 

Rosuvastatin             10 mg

Excipients                     q.  s 

ROUTE OF ADMINISTRATION

Oral 

PRESENTATION

Box with 3 blisters containing 10 tablets each

INDICATIONS

Treatment of Hypercholesterolaemia

Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.

Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.

Prevention of Cardiovascular Events

Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event as an adjunct to correction of other risk factors.

CONTRAINDICATIONS

Lustatin is contraindicated:

In patients with hypersensitivity to rosuvastatin or to any of the excipients.

In patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).

In patients with severe renal impairment (creatinine clearance <30 ml/min).

In patients with myopathy.

In patients receiving concomitant ciclosporin.

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 (see Warnings and Precautions, Drug Interactions)

STORAGE AND HANDLING INSTRUCTION

Store below 30ºC