Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Fenofibrate (nanonized)
EURO ASIA MEDICO PTE. LTD.
C10AB05
TABLET
Fenofibrate (nanonized) 145 mg
ORAL
Prescription Only
Ethypharm (Chateauneuf en Thymerais) (manufacture of tablets)
ACTIVE
2021-04-14
For the use of Registered Medical Practitioner or a Hospital only 1. NAME OF THE MEDICINAL PRODUCT EP-FENO 145 MG TABLET Fenofibrate Tablets 145mg 2. COMPOSITION: Each tablet contains: Fenofibrate (Nanonized)………………………………….145 mg Excipients: Lactose anhydrous, Hypromellose, Sodium Lauryl sulphate, Simethicone emulsion 30%, Croscarmellose sodium, Magnesium stearate. 3. PHARMACEUTICAL FORM Tablet EP-Feno 145 mg Tablet is available as white to off-white biconvex oblong tablet, 15.5 x 8.5 mm, embossed “F” on one side and “145” 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. EP Feno 145 mg Tablet is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. EP Feno 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 200 mg capsule or one 160 mg 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), complemen Přečtěte si celý dokument
For the use of Registered Medical Practitioner or a Hospital only 1. NAME OF THE MEDICINAL PRODUCT EP-FENO 145 MG TABLET Fenofibrate Tablets 145mg 2. COMPOSITION: Each tablet contains: Fenofibrate (Nanonized)………………………………….145 mg Excipients: Lactose anhydrous, Hypromellose, Sodium Lauryl sulphate, Simethicone emulsion 30%, Croscarmellose sodium, Magnesium stearate. 3. PHARMACEUTICAL FORM Tablet EP-Feno 145 mg Tablet is available as white to off-white biconvex oblong tablet, 15.5 x 8.5 mm, embossed “F” on one side and “145” 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. EP Feno 145 mg Tablet is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. EP Feno 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 200 mg capsule or one 160 mg 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), complemen Přečtěte si celý dokument