Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
sitagliptin, metformin hydrochloride
Merck Sharp & Dohme B.V.
A10BD07
sitagliptin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For patients with type-2 diabetes mellitus:Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Velmetia is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.Velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.
Revision: 37
Authorised
2008-07-16
37 B. PACKAG E LEAFLET 38 PACKAGE LEAF LET: INFORMATION FOR THE PATIENT VELMETIA 50 MG/850 MG FILM- COATED TABLETS VELMETIA 50 MG/1,000 MG FILM-COATED TABLETS sitaglipti n/metformin hydrochloride READ ALL OF THIS LEAFL ET CA REFULLY BEFORE Y OU START TAKING THIS MED ICINE BECAUSE IT CONTAINS IMPORTANT INF ORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you h ave any further questions, ask your doctor , pha rmacist, or nurse. - This medicine has been prescri bed f or you only. Do not pass it on to others . It may harm them, even if their signs of illness are the same a s yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This include s any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Velmetia is a nd what it is used f or 2. What you need to kno w before yo u take Velmetia 3. How to take Velmetia 4. Possible side effects 5. How to store Velmetia 6. Contents of t he pack and othe r information 1. WHAT VELMETIA IS AND WHA T IT IS USED FO R Velmetia contain s two different medi cines called sitagliptin a nd metformi n. • sitagliptin belongs to a class of me dicines called DPP -4 inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belon gs to a class of m edicines called biguanides. They work t ogether to control blood sugar levels i n adult patients with a fo rm of diabetes called ‘ type 2 diabetes mell itus’. This medicine helps to increase the levels of insulin produced after a meal and low ers the amoun t of sugar made by yo ur body. Along with die t and exercise, thi s medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones) . What is type 2 diabetes? Type 2 diab etes is a condit ion in wh ich your body d oes not make enough insulin, and the in sulin that your body produ ces does no t work as well as it should. Your body can also make too much sugar. When this ha ppens , sugar (glucose) bu ilds Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MED ICINAL PRODUCT Velmetia 50 mg/850 mg film- coated tablets Velmetia 50 mg/1,000 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Velmetia 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metf ormin hydrochloride. Velmetia 50 mg/1,000 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metf ormin hydrochloride. For the full li st of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Velmetia 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tablet with “515” debossed on one side. Velmetia 50 mg/1,000 mg film-coated tablets Capsule-shaped, red film- coated tablet with “ 577 ” debossed on one side . 4. CLINIC AL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellit us: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic cont rol in patients inadequately controlled on their maximal tolerated dose of m et formin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e., triple combinatio n t herapy) as an adjunct to diet and exercise in patients inadequately contr ol led on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a peroxisome proliferator - activated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exerc is e in patients inadequately controlled on their maximal tolerated dose of metformin and a PP AR agonist. Velmetia is also indicated as add - on to insulin (i.e., triple combinatio n t herapy) as an adjunct to diet and exercise to improve glycaemic control i n patients when stable dose of insulin and metformin alone do not provide adequate glyca Прочетете целия документ