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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inegy 10 mg / 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White to off-white capsule-shaped tablets with code "313" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HYPERCHOLESTEROLAEMIA_
INEGY 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
INEGY contains ezetimibe and simvastatin. Simvastatin (20-40 mg) has been shown to reduce the frequency of
cardiovascular events (see section 5.1). A beneficial effect of INEGY or ezetimibe on cardiovascular morbidity and
mortality has not yet been demonstrated.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_
INEGY 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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_HYPERCHOLESTEROLAEMIA_
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with
INEGY.
Route of administration is oral. The dosage range of INEGY is 10/10 mg/day through 10/80 mg/day in the evening. All
dosages may not be available in all member states. The typical dose is 10/20 mg/day or 10/40 mg/day given as a single
dose in the evening. The 10/80-mg dose is only recommended in patients with se
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