Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, United Kingdom
Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
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.
The recommended dose is 200 mg daily administered as one capsule of Fenofibrate 200 mg. The dose can be titrated up to 267 mg daily administered as one capsule of Fenofibrate 267 mg or 4 capsules of Fenofibrate 67 mg, if required. This maximum dose is not recommended in addition to a statin.
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.
Fenofibrate 200 mg Capsules are not recommended for use in patients with hepatic impairment due to the lack of data.
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.
Capsules should be swallowed whole during a meal.
Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported.
No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.
2 years.
Store in the original package. Do not store above 25°C.
Blister strip of clear transparent PVC film coated with PVdC on the inner side with a backing of aluminium foil.
Pack size of 10, 14, 20, 28, 30, 56, 60 or 90 capsules. Not all pack sizes may be marketed.
No special requirements.
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