Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE
METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2023-02-07
1 BIJSLUITER: INFORMATIE VOOR DE PATIËNT SITAGLIPTINE/METFORMINE HYDROCHLORIDE GENERICON 50 MG/850 MG FILMOMHULDE TABLETTEN SITAGLIPTINE/METFORMINE HYDROCHLORIDE GENERICON 50 MG/1000 MG FILMOMHULDE TABLETTEN sitagliptine/metformin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains two different medicines called sitagliptin and metformin. • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belongs to a class of medicines called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, this 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 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When t Olvassa el a teljes dokumentumot
1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Sitagliptine/Metformine hydrochloride Genericon 50 mg/850 mg filmomhulde tabletten Sitagliptine/Metformine hydrochloride Genericon 50 mg/1000 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. [Product name] 50 mg/1 000 mg film-coated tablets Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1 000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). [Product name] 50 mg/850 mg film-coated tablets Pink, capsule-shaped, biconvex, film-coated tablet of approximately 20.2mm in length, 9.9mm in width and 7.0mm in thickness, with "585" engraved on one side and break line on the other side. [Product name] 50 mg/1 000 mg film-coated tablets Red, capsule-shaped, biconvex, film-coated tablet of approximately 21.4mm in length, 10.4mm in width and 7.1mm in thickness, with "5100" engraved on one side and break line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: [Product name] 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. [Product name] 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. [Product name] is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (P Olvassa el a teljes dokumentumot