The diet should be continued during treatment with this medicinal product. Response to treatment should be monitored by recording serum lipid levels. If an adequate lipid-lowering response has not been achieved after several months of treatment with fenofibrate (e.g. 3 months), complementary or different therapeutic measures should be considered.
Posology: Adults: Recommended daily dose: 1 film-coated tablet (containing 145 mg fenofibrate) daily.
Patients currently taking fenofibrate 200 mg or 160 mg once daily can be changed to LIPANTHYL PENTA 145 (1 film-coated tablet daily) without further dose adjustment.
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 (eGFR) <60 ml/min/1.73 m2 (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/1.73 m2, is present.
If eGFR is between 30 and 59 ml/min/1.73 m2, the daily dose should not exceed 100 mg fenofibrate (standard) or 67 mg micronised.
If, during follow-up, the eGFR decreases persistently to <30 ml/min/1.73 m2, fenofibrate should be discontinued.
Hepatic impairment: LIPANTHYL PENTA 145 is not recommended for patients with hepatic impairment due to the lack of data.
Children and adolescents: The safety and efficacy of fenofibrate have not been sufficiently established in children and adolescents below the age of 18. No studies are available. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years.
Method of administration: The medicinal product may be given at any time of the day, with or without food (see Pharmacology: Pharmacokinetics under Actions).
The film-coated tablet should be swallowed whole with a glass of water.