Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Fenofibrate 160 mg Tablets are indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking one fenofibrate 200mg capsule can be changed to one fenofibrate 160 mg tablet without further dose adjustment.
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 (see 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.
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.
Patients with hepatic disease have not been studied.
Dietary measures initiated before therapy should be continued.
If after several months of fenofibrate administration (e.g. 3 months) serum lipid levels have not been reduced satisfactorily, complementary or different therapeutic measures should be considered.
Tablets should be swallowed whole during a meal.
No case of overdosage has been reported. No specific antidote is known. If an overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.
36 months.
No special precautions for storage.
Blister strips (PVC/PVDC – Aluminium).
Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.
Hospital pack sizes: 280 and 300 tablets.
Not all pack sizes may be marketed.
No special requirements.
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