Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
Abbott Healthcare Products Ltd
FENOFIBRATE
200 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 200mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg fenofibrate. Excipients with known effect: Each capsule contains 101 mg of lactose monohydrate. For the 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 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 one capsule Lipantil Micro 200mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/08/2013_ _CRN 2135975_ _page number: 1_ Special populations Geriatric population: In elderly patients without renal impairment, the usual adult dose is recommended. Renal impairment: Dosage reduction is required in patients with renal impairment (creatine clearance < 60mL/min). Therefore Lipantil Micro 200mg should not be used in patients with renal impairment. Hepatic impairment: Lipantil Micro 200mg is no Pročitajte cijeli dokument