国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
sitagliptin
Merck Sharp & Dohme B.V.
A10BH01
sitagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Revision: 27
Authorised
2010-03-15
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: I NFO RMATION FOR THE PATIENT RISTABEN 25 MG FILM- COATED TABLETS RISTABEN 50 MG FILM-COATED TABLETS RISTABEN 100 MG FILM- COATED TABLETS sitagliptin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORM ATION FOR YOU. - Keep t his leaflet. You may need to read it again. - If you ha ve any furth er questions, ask your doctor, pharmacist , or nurse. - This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects , talk to your doctor, phar macist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS I N THIS LEAFLET 1. What Ristaben is and what it is used for 2. What you need to know b efore you take Ristaben 3. How to take Ristaben 4. Possible side effects 5. How t o store Ristaben 6. Contents of the pack and other information 1. WHAT RISTABEN IS AND WHAT IT IS USED FOR Ristaben contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibi tors (dipept idyl peptidase -4 inhib itors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produc ed after a meal and d ecreases the amount of sugar made by the body. Your doctor has p rescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain oth er medicine s (insu lin, metformin, sulphonylureas, or glitazones) that l ower blood s ugar, which you may al ready be taking for your diabetes together with a food and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition in which your bod y d oes not mak e enoug h insulin, and the insulin that your body produces do es not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ristaben 25 mg film- coated tablets Ristaben 50 mg film- coated tablets Ristaben 100 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ristaben 25 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 2 5 mg sitagliptin. Ristaben 50 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin. Ristaben 100 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet) . Ristaben 25 mg film-coated tablets Round, pink film - coated tablet with “221” on one side. Ritaben 50 mg film- coated tablets Round, light beige film - coated table t with “112” on one side . Ristaben 100 mg film- coated tablets Round, beige f ilm- coated tablet with “277” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients w ith type 2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy : • in patients inadequately controlled by diet and exercise alone and for whom metfo rmin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with : • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal t olerated dose of a sulphonylurea alone do not provide adequate glycaemic co ntrol and when metformin is inappropriate due to contraindications or intolerance. 3 • a peroxisome proliferator - activated receptor gamma (PPAR ) agonist (i.e. a thiazolidinedione) whe n use of a PPAR agonist is appropriate and when diet and exercise plus t he PPAR agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with : • a sulphonylurea and metformin when diet and ex 阅读完整的文件