Ezetimibe

1). Hypercholesterolaemia Ezetimibe/Atorvastatin Tablets is indicated as adjunct to diet for treatment of primary (heterozygous and homozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in adult patients who are adequately controlled with atorvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products.

SPC-EZETIMIBE (ezetimibe) is indicated as an adjunct to lifestyle changes, including diet, when the response to diet and other non-pharmacological measures alone has been inadequate. Primary Hypercholesterolemia SPC-EZETIMIBE, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for: • the reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and • to increase high density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.

SPC-EZETIMIBE, administered in combination with fenofibrate, is indicated for: • the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. Homozygous Familial Hypercholesterolemia (HoFH) SPC-EZETIMIBE, administered with a statin, is indicated for: • the reduction of elevated total-C and LDL-C levels in patients with HoFH as an adjunct to treatments such as LDL apheresis or if such treatments are not possible.

1 INDICATIONS AND USAGE Ezetimibe tablets are indicated: • In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

• In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. • In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.

• In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.