Fenofibrate

g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

8 DRUG INTERACTIONS ........................................................................................................................................ 12 DOSAGE AND ADMINISTRATION ....................................................................................................................

16 OVERDOSAGE ...................................................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................................

17 STORAGE AND STABILITY ................................................................................................................................ 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................................................

18 PART II: SCIENTIFIC INFORMATION .............................................................................................................. 19 PHARMACEUTICAL INFORMATION ................................................................................................................

1 ). 2 ). 1 ). 1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

2 Severe Hypertriglyceridemia Fenofibrate tablet USP is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. 1 )] .

Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.