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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 67mg capsules_, _hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 67mg fenofibrate.
Excipients: Each capsule contains 33.8 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Yellow hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Micro 67mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight
reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL
cholesterol are not adequately controlled.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
Adults: The recommended initial dose is 200mg daily administered as 3 x 67mg capsules.
The dose can be titrated up to 4 capsules if required.
Lipantil Micro 67mg should always be taken with food, because it is less well absorbed from an empty stomach.
Dietary measures instituted before therapy should be continued.
The response to therapy should be monitored by determination of serum lipid values and the dosage may be altered
within the range 2-4 capsules of Lipantil Micro 67mg daily.
Elderly patients: In elderly patients without renal impairment, the normal adult dose is recommended.
Patients with renal impairment: In renal dysfunction, the dosage may need to be reduced depending on the rate of
creatinine clearance, for example:
CREATININE CLEARANCE (ML/MIN)
DOSAGE
20 - 60
Two 67mg capsules
IRISH MEDICINES BOARD
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