Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Lipantil Micro 67mg 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 200mg daily administered as three capsules of Lipantil Micro 67mg.
The dose can be titrated up to 267mg daily administered as 4 capsules of Lipantil Micro 67mg, 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 (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.
Lipantil Micro 67mg is not recommended for use in patients with hepatic impairment due to the lack of data.
In children, the recommended dose is one capsule (67mg) micronised fenofibrate/day/20kg body weight (see section 4.4).
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.
3 years.
Store in the original package. Do not store above 30°C.
Pack of 28, 56, 84, 90 capsules in blisters (PVC/Aluminium).
* Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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