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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil
®
Supra 160 mg, film-coated tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160.0 mg fenofibrate.
_For excipients, see 6.1._
3 PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets engraved “160” on one side and “Fournier logo” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as
types III and V dyslipidaemias although only a few patients have been treated during clinical trials) in patients
unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity),
particularly when there is evidence of associated risk factors.
The treatment of secondary hyperlipoproteinaemias is indicated if the hyperlipoproteinaemia persists despite effective
treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus).
Dietary measures initiated before therapy should be continued.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
Adults: The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking
one _Lipantil Micro 200 mg _capsule can be changed to one Lipantil Supra 160 mg tablet without further dose
adjustment.
Elderly patients: The usual adult dose is recommended.
Patients with renal impairment: Dosage reduction is required in patients with renal impairment. The use of dosage
forms containing a lower dose of active ingredient (67 mg micronised fenofibrate capsules or 100 mg standard
fenofibrate capsules) is recommended in these patients.
Children: The use of the 160 mg dosage form is contraindicated in children.
Hepatic diseas
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