País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
Repaglinide
NOVEM PHARMA PRIVATE LIMITED
A10BX02
TABLET
Repaglinide 0.50 mg
ORAL
Prescription Only
Pharmathen S.A.
ACTIVE
2021-11-12
1.4.3 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Repaglinide MEVON 0.5 mg tablets Repaglinide MEVON 1 mg tablets Repaglinide MEVON 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Repaglinide MEVON 0.5 mg tablets: Each tablet contains 0.5 mg of repaglinide. Repaglinide MEVON 1.0 mg tablets: Each tablet contains 1.0 mg of repaglinide. Repaglinide MEVON 2.0 mg tablets: Each tablet contains 2.0 mg of repaglinide. For the full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet Repaglinide MEVON 0.5 mg tablets are white, round and biconvex. Repaglinide MEVON 1 mg tablets are yellow, round and biconvex. Repaglinide MEVON 2 mg tablets are pink, round and biconvex. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels are also of value in monitoring the patient’s response to therapy. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure). Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic pati Llegiu el document complet