Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
FENOFIBRATE
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
C10AB05
145mg
TABLET, FILM COATED
FENOFIBRATE 145mg
ORAL
Prescription Only
Fournier Laboratories Ireland Limited
ACTIVE
2009-03-18
Base Label Update 009100313 Updated 15-May-2013 1. NAME OF THE MEDICINAL PRODUCT LIPANTHYL® PENTA 145, Film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 145.0mg fenofibrate (nanoparticles). Excipients with known effect: each tablet contains: - 132.00mg of Lactose monohydrate - 145.00mg of Sucrose - 0.50 mg of Soybean lecithin For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Hypercholesterolaemia and hypertriglyceridaemia alone or combined (type IIa, IIb, III, IV 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 factors such as hypertension and smoking. The treatment of secondary hyperlipoproteinaemia is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g.dyslipidaemia in diabetes mellitus). 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. 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 one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200mg capsule or one 160mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment. SPECIAL POPULATIONS Geriatric patients: In elderly patients, without renal impairment, the usual adult dose is recommended. Renal impairment: Dosage reduction is Leggi il documento completo
Updated 23 Feb 2022 (RDCCDS000394/10) 1. NAME OF THE MEDICINAL PRODUCT LIPANTHYL ® PENTA 145, Film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 145.0mg fenofibrate (nanoparticles). Excipients with known effect: each tablet contains: - 132.00mg of Lactose monohydrate - 145.00mg of Sucrose - 0.50 mg of Soybean lecithin For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Hypercholesterolaemia and hypertriglyceridaemia alone or combined (type IIa, IIb, III, IV 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 factors such as hypertension and smoking. The treatment of secondary hyperlipoproteinaemia is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g.dyslipidaemia in diabetes mellitus). Dietary measures initiated before therapy should be continued. LIPANTHYL ® PENTA 145 is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Lipanthyl does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology: Adults: The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200mg capsule or one 160mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment. For hyperlipidaemia indications, 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 me Leggi il documento completo