Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
Abbott Healthcare Products Ltd
FENOFIBRATE
215 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Supra 215 mg, film-coated tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 215.0 mg fenofibrate. Excipients with known effect: each tablet contains: - 134.4 mg of lactose monohydrate - 2.28 mg of Sunset yellow lake (E110) - 5.31 mg of Allura red AC lake (E129) - 0.6 mg of Soybean lecithin For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Orange-red, oblong, film-coated tablet engraved “215” on one side and “Fournier logo” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lipantil Supra 215mg 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. 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 initial dose is 160 mg daily administered as one Lipantil Supra 160 mg tablet. The dose can be titrated up to 215 mg daily administered as one Lipantil Supra 215 mg tablet. Patients currently taking one Lipantil Micro 267mg capsule can be changed to one Lipantil Supra 215 mg tablet without further dose adjustment. Special populations Geriatric population: In elderly patients, without renal impairment, the usual adult dose is recommended Renal impairment: IRISH MEDICINES BOARD __________________________________________________________________________________ Read the complete document