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ATORVASTATIN 20 MG FILM-COATED TABLETS

Information leaflet

                                                    Irish Medicines Board




                                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 according to baseline LDL-C levels, the goal of therapy, and patient response.




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Date Printed 30/08/2011                               CRN 2099667                                         page number: 1
                                                      Irish Medicines Board




 The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The
 maximum dose is 80 mg once a day.

 Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia

 The majority of patients are controlled with atorvastatin 10 mg once a day. A therapeutic response is evident within 2
 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during
 chronic therapy.

 Heterozygous familial hypercholesterolaemia

 Patients should be started with atorvastatin 10 mg daily. Doses should be individualised and adjusted every 4 weeks to
 40 mg daily. Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may
 be combined with 40 mg atorvastatin once daily.

 Homozygous familial hypercholesterolaemia

 Only limited data are available (see section 5.1).

 The dose of atorvastatin in patients with homozygous familial hypercholesterolaemia is 10 to 80 mg daily (see section
 5.1). Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients
 or if such treatments are unavailable.

 Prevention of cardiovascular disease

 In the primary prevention trials the dose was 10 mg/day. Higher doses may be necessary in order to attain (LDL-)
 cholesterol levels according to current guidelines.

 Renal impairment

 No adjustment of dose is required (see section 4.4).

 Hepatic impairment

 Atorvastatin should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2). Atorvastatin is
 contraindicated in patients with active liver disease (see section 4.3).

 Use in the elderly

 Efficacy and safety in patients older than 70 using recommended doses is similar to those seen in the general
 population.

 Paediatric use

 Hypercholesterolaemia
 Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and
 patients should be re-evaluated on a regular basis to assess progress.

 For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up
 to 20 mg per day. Titration should be conducted according to the individual response and tolerability in paediatric
 patients. Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg,
 is limited.

 There is limited experience in children between 6-10 years of age (see section 5.1). Atorvastatin is not indicated in the
 treatment of patients below the age of 10 years.




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Date Printed 30/08/2011                               CRN 2099667                                         page number: 2
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