Lipitor™ 20mg chewable tablets.

Each chewable tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).

Excipient(s) with known effect:

Each Lipitor 20 mg chewable tablet contains 2.5 mg aspartame.

For the full list of excipients, see section 6.1.

Chewable tablet

White to off-white, round chewable tablets with pink to purple specks debossed "20" on one side and "LCT" on the other measuring 8.7 mm in diameter.

Hypercholesterolaemia

Lipitor 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 or 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 nonpharmacological measures is inadequate.

Lipitor 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 adult 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.

Posology

The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor.

The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.

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 Lipitor 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 Lipitor 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 hypercholesterolemia 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.

Patients with renal impairment

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

Patients with hepatic impairment

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

Elderly patients

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

Paediatric population

Hypercholesterolaemia

Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-eva luated 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.

Method of administration

Lipitor is for oral administration. Each daily dose of atorvastatin is given all at once. Lipitor chewable tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food.

Lipitor is contraindicated in patients:

− with hypersensitivity to the active substance or to any of the excipients listed in section 6.1

− with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal

− during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)