Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered.
Posology: Adults: The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200 mg capsule or one 160 mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment.
Special population: 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 (see Patients with renal impairment as follows).
Patients with 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: EP-Feno 145 mg is not recommended for use in patients with hepatic impairment due to the lack of data.
Paediatric population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore the use of fenofibrate is not recommended in paediatric subjects under 18 years.
Method of administration: Tablet may be given at any time of the day, with or without food (see Pharmacology: Pharmacokinetics under Actions). Tablets should be swallowed whole with a glass of water.