País: Unión Europea
Idioma: inglés
Fuente: 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) Leer el documento completo
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 Leer el documento completo