Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Lipidil NT 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 one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200mg capsule or one 160 mg tablet can be changed to one 145 mg fenofibrate 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 (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.
Lipidil NT 145 mg is 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.
Film-coated tablet may be given at any time of the day, with or without food (see section 5.2 Pharmacokinetic properties). Tablets should be swallowed whole with a glass of water.
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 an overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.
3 years.
Store below 30°C.
Thermoformed blister strips (clear PVC/PE/PVDC sealed with aluminium complex).
Packs of 10 or 14 tablets.
Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.
Hospital pack sizes: 280 (10 × 28) and 300 (10 × 30) tablets.
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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