Name of the medicinal product: ATOR-CHOL

Content: Each tablet contains 20 mg or 40 mg atorvastatin

Pharmaceutical form: Film coated Tablet

Pharmacotherapeutic group: Lipid modifying agents

Packaging description: Paper box which contains 30 tablets in blisters ALU/ALU along with prescribed information leaflet.

ATOR-CHOL belongs to a group of medicines known as statins. Statins lower blood lipids such as cholesterol and triglycerides.
ATOR-CHOL is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in patients 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.
Atorvastatin is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Atorvastatin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients - 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

The patient should be placed on a standard cholesterol-lowering diet before receiving ATOR-CHOL and should continue on this diet during treatment with ATOR-CHOL.The usual starting dose is 10 mg once a day. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. 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
The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily . 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.
Paediatric population
Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia. For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day. The dose may be increased to 80 mg daily, according to the response and tolerability.
Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
Renal impairment
No adjustment of dose is required