Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METFORMINEHYDROCHLORIDE 850 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 662,7 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk
METFORMINEHYDROCHLORIDE 850 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 662,7 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 90 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 90 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2021-12-21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JANECLUC 50 MG/850 MG FILMOMHULDE TABLETTEN JANECLUC 50 MG/1000 MG FILMOMHULDE TABLETTEN Sitagliptin / 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 JANECLUC is and what it is used for 2. What you need to know before you take JANECLUC 3. How to take JANECLUC 4. Possible side effects 5. How to store JANECLUC 6. Contents of the pack and other information 1. WHAT JANECLUC IS AND WHAT IT IS USED FOR JANECLUC 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 this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart dise Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT JANECLUC 50 mg/850 mg filmomhulde tabletten JANECLUC 50 mg/1000 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The following information applies solely to product JANECLUC 50 mg/850 mg Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. The following information applies solely to product JANECLUC 50 mg/1000 mg Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). The following information applies solely to product JANECLUC 50 mg/850 mg Capsule-shaped, white to off- white film-coated tablets debossed with "S18" and break line on one side and "H" on the other side. The following information applies solely to product JANECLUC 50 mg/1000 mg Capsule-shaped, yellow film-coated tablets debossed with "S19" and break line on one side and "H" 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: JANECLUC 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. JANECLUC 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. JANECLUC is indicated as triple combination therapy with a peroxisome proliferator- activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal Les hele dokumentet