Downsterolin

Downsterolin 10 mg/20 mg or 10 mg/40 mg Film coated Tablets 2. Qualitative and quantitative composition Each tablet contains 10 mg ezetimibe and 20 or 40 mg of simvastatin. Therapeutic indications Prevention of Cardiovascular Events DOWNSTEROLIN is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not. Hypercholesterolaemia DOWNSTEROLIN is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: • patients not appropriately controlled with a statin alone • patients already treated with a statin and ezetimibe Homozygous Familial Hypercholesterolaemia (HoFH) DOWNSTEROLIN is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. low-density lipoprotein [LDL] apheresis).