Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
FENOFIBRATE
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
C10AB05
160 mg
TABLET, FILM COATED
FENOFIBRATE 160 mg
ORAL
Prescription Only
Astrea Fontaine
ACTIVE
2001-08-07
Base Label Update 009100313 Updated 15-May-2013 1. NAME OF THE MEDICINAL PRODUCT LIPANTHYL® SUPRA 160 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 160.0mg fenofibrate. Excipients with known effect: each tablet contains: - 138.4mg of Lactose monohydrate - 0.56mg of Soybean lecithin 3. PHARMACEUTICAL FORM Film-coated tablet.White, oblong, film-coated tablets engraved “160” on one side and “Fournier logo” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as types III and V dyslipidaemias) in patients unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity), particularly when there is evidence of associated risk such as hypertension and smoking. The treatment of secondary hyperlipoproteinaemias is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus). Appropriate dietary measures initiated before therapy should be continued. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-Cholesterol, triglycerides), 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 of LIPANTHYL® SUPRA 160 mg tablets is one tablet taken once daily. Patients currently taking one 160mg tablet can be changed to one 145mg fenofibrate tablet without further dose adjustment. SPECIAL POPULATIONS Geriatric population: In elderly patients, without renal impairment,the usual adult dose is recommended in elderly patients. Renal impairment: Dosage reduction is requ Olvassa el a teljes dokumentumot
Updated: 23 Feb 2022 (RDCCDS000394/10) LIPANTHYL SUPRA 160 Film-coated tablets Fenofibrate 1. NAME OF THE MEDICINAL PRODUCT LIPANTHYL SUPRA 160 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 160.0mg fenofibrate. Excipients with known effect: each tablet contains: - 138.4mg of Lactose monohydrate - 0.56mg of Soybean lecithin 3. PHARMACEUTICAL FORM Film-coated tablet. White, oblong, film-coated tablets engraved “160” on one side and “Fournier logo” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as types III and V dyslipidaemias) in patients unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity), particularly when there is evidence of associated risk such as hypertension and smoking. The treatment of secondary hyperlipoproteinaemias is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus). Appropriate dietary measures initiated before therapy should be continued. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-Cholesterol, triglycerides), 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 of LIPANTHYL SUPRA 160 mg tablets is one tablet taken once daily. Patients currently taking one 160mg tablet can be changed to one 145mg fenofibrate tablet without further dose adjustment. SPECIAL POPULATIONS Geriatric population: In elderly patients, without renal impairment, the usual adult dose is recommended in elderly patients. Renal impairment: Dosage reduction is required in patients with renal impairment. In moderate chronic kidney disease (creatinine clearance 30 to 59 mL/min), Olvassa el a teljes dokumentumot