Compositon/Ingredients: Fenofibrate

• Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
• Mixed hyperlipidaemia when a statin is contraindicated or not tolerated or in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

• Known hypersensitivity to any of the ingredients.
• Severe renal dysfunction.
• Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
• Known gallbladder disease.

• Adults, geriatric populations: 1 tablet/day.
• Renal impairment: Dosage reduction is required.
• Severe chronic kidney disease, hepatic impairment, children < 18 years: Fenofibrate is not recommended for use.

• In patients taking anticoagulants, the dose of anticoagulant should be reduced by about one third when treatment with fenofibrate is started. Check the prothrombin level more frequently and adapt the dosage of oral anticoagulant during treatment by fenofibrate and 8 days after its interruption.
• Hypothyroidism may be a factor predisposing to the muscle syndrome.
• Measurement of transaminases every 3 months, during the first 12 months of treatment, temporary interruption of treatment in case of an increase in SGPT (ALT) to > 100 IU.
• Biliary complications are more prone to occur in patients with biliary cirrhosis or gallstones.
• Fenofibrate therapy should be discontinued if serum CPK concentrations become markedly elevated or if myositis/myopathy is suspected or diagnosed.
• Stevens-Johnson syndrome and toxic epidermal necrolysis, pancreatitis.
• Pregnancy and lactation.
• Patients should be aware of how they react to drug before driving or operating machinery.

Store at temperature below 30°C, protect from light.