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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Actavis 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: 10 mg of atorvastatin as atorvastatin magnesium trihydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex film-coated tablets marked with “10” on one side and “A” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Actavis is used as a supplement to a change in diet for reduction of elevated total cholesterol,
LDL-cholesterol, apolipoprotein B, or triglycerides in patients with primary hypercholesterolaemia including
heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia (such as Frederickson's types IIa
and IIb), when satisfactory results have not been obtained by a special diet or measures other than medical treatment.
Atorvastatin Actavis is also indicated to reduce total-cholesterol and LDL-cholesterol in patients with homozygous
familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such
treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section
5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin Actavis and should
continue on this diet during treatment with Atorvastatin Actavis. Doses should be determined individually according to
the baseline LDL-cholesterol value, treatment objective and patient response.
The usu
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