Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sitagliptin Phosphate Monohydrate
NOVUGEN PHARMA SDN. BHD.
Sitagliptin Phosphate Monohydrate
3X10 Tablets; 1X10 Tablets; 6X10 Tablets; 10X10 Tablets; 50X10 Tablets; 100X10 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ SITAVIO FILM COATED TABLETS Sitagliptin 50mg, 100mg 1 WHAT IS IN THIS LEAFLET 1. What Sitavio is used for 2. How Sitavio works 3. Before you use Sitavio 4. How to use Sitavio 5. While you are using Sitavio 6. Side effects 7. Storage and Disposal of Sitavio 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SITAVIO IS USED FOR Sitavio is a tablet that contains 50 or 100 mg of sitagliptin as the active ingredient. • Sitavio helps to improve the levels of insulin after a meal. • Sitavio decreases the amount of sugar made by the body. • Sitavio works when blood sugar is high, especially after a meal. This is when the body needs the greatest amount of help in lowering blood sugar. Sitavio also lowers blood sugar between meals. • Sitavio by itself is unlikely to cause low blood sugar (hypoglycemia) because it does not work when your blood sugar is low. HOW SITAVIO WORKS Sitavio is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin- dependent diabetes mellitus, or NIDDM. BEFORE YOU USE SITAVIO − _When you must not use it _ Do not take Sitavio: • If you have allergic toward any of the component in Sitavio. − _ Before you start to use it _ Tell your doctor or pharmacist if you are allergic to any medicines or if have had: • Type 1 diabetes • diabetic ketoacidosis (increased ketones in the blood or urine) • any kidney problems, or any past or present medical problems • an allergic reaction to Sitavio • gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis. − _Taking other medicines _ Sitavio may be taken with most medicines. Tell your doctor about all the medicines you take. This includes presc Baca dokumen lengkapnya
1. NAME OF THE MEDICINAL PRODUCT Sitavio 50mg Film Coated Tablets Sitavio 100mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SITAVIO 50MG FILM COATED TABLETS: Each tablet contains 64.250mg of Sitagliptin Phosphate Monohydrate equivalent to 50mg Sitagliptin. SITAVIO 100MG FILM COATED TABLETS: Each tablet contains 128.500mg of Sitagliptin Phosphate Monohydrate equivalent to 100mg Sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablets. SITAVIO 50MG FILM COATED TABLETS: Beige, round shaped film coated tablet debossed with ‘C 33’ on one side of the tablet and plain on the other side SITAVIO 100MG FILM COATED TABLETS: Beige, round shaped film coated tablet debossed with ‘C 32’ on one side of the tablet and plain on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MONOTHERAPY Sitavio is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. COMBINATION WITH METFORMIN Sitavio is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control. Initial combination therapy or maintenance of combination therapy may not be appropriate for all patients. These management options are left to the discretion of the health care provider. COMBINATION WITH A SULPHONYLUREA Sitavio is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulphonylureas when treatment with maximal tolerated dose of sulphonylurea alone, with diet and exercise, does not provide adequate glycemic control and when metformin is inappropriate due to contraindications or intolerance. COMBINATION WITH METFORMIN AND A SULPHONYLUREA Sitavio is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin and a sulphonylurea when dual therapy with these t Baca dokumen lengkapnya