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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 20 mg Film
-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
_Excipients_
Each 20 mg film
-coated tablet contains 121.68 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film
-coated tablet
White to off
-white, capsule-shaped, film-coated tablet, debossed with "93" on one side and "7311" on the other side
of the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolaemia_
Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL
-cholesterol
(LDL-C), apolipoprotein B and triglycerides in adults, adolescents and children aged 10 years and older with primary
hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed)
hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other
non
-pharmacological measures is inadequate.
Atorvastatin is also indicated to reduce total
-C and LDL-C in adults 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
Posology
The patient should be placed on a standard cholesterol
-lowering diet before receiving atorvastatin and should continue
on this diet during treatment with atorvastatin.
The dose should be individualised accor
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