TRIFILIP
- Packing3 blister packs of 10 capsules
- Shelf life36 months
- CompositionFenofibrate (micronised) 67 mg
- Posology and pharmaceutical formHard capsule
Summary of product characteristic
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Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended initial dose is 200 mg fenofibrate daily, divided into multiple doses and taken with food, as absorption is reduced when the stomach is empty. Any dietary measures used prior to treatment should be continued.
Treatment response should be monitored by assessing serum lipid levels, and the dose may be adjusted within the range of 2 to 4 fenofibrate 67 mg tablets daily (equivalent to 1 to 2 fenofibrate 134 mg tablets daily).
Paediatric population
the recommended dose is micronised fenofibrate 67 mg/day/20kg body weight.
Elderly patients (≥ 65 years old)
No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m2.
Renal impairment
Fenofibrate should not be used if severe renal impairment, defined as eGFR < 30 mL/min per 1.73 m2, is present. If eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily. If, during follow-up, the eGFR decreases persistently to < 30 mL/min per 1.73 m2, fenofibrate should be discontinued.
Hepatic impairment
Fenofibrate is not recommended for use in patients with hepatic impairment due to the lack of data.
Method of administration
For oral use, capsules should be swallowed whole during a meal.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Fenofibrate is contraindicated in patients with severe liver or renal impairment, known gallbladder disease, biliary cirrhosis, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
- Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
- Use during pregnancy and breastfeeding.
- Severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m2).
This information is for reference only. Please read the leaflet inside
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