Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
Abbott Healthcare Products Ltd
200 Milligram
Capsules Hard
2007-01-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Micro 200mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg fenofibrate. Excipient: Each capsule contains 101 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Orange hard gelatin capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lipantil Micro 200mg 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 1 x 200mg capsule. Lipantil Micro 200mg should always be taken with food, because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued. 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: *Lipantil Micro 67mg should be used in this case . Hepatic disease: Patients with hepatic disease have not been studied. CREATININE CLEARANCE (ML/MIN) DOSAGE* 20 – 60 Two 67mg capsules 10 – 20 One 67mg capsule IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/04/2012_ _CRN 21105 Soma hati kamili