Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
Abbott Healthcare Products Ltd
FENOFIBRATE
67 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
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 with known effect: Each capsule contains 33.8 mg of lactose monohydrate. For the 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 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. Posology: Adults The recommended dose is 200mg daily administered as three capsules Lipantil Micro 67mg capsules. The dose can be titrated up to 267mg daily administered as 4 capsules Lipantil Micro 67mg if required. Special populations Geriatric population: In elderly patients without renal impairment the usual adult dose is recommended. Renal impairment: IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/08/2013_ _CRN 2135975_ _page number: 1_ Dosage reduction is required in patients with renal impairment (creatine clearance <60mL/min): In patients wi Read the complete document