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  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).