Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SITAGLIPTINEHYDROCHLORIDE 1-WATER 113,4 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 100 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
SITAGLIPTINEHYDROCHLORIDE 1-WATER 113,4 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 100 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
Sandoz B.V. Page 1/7 Simlerid 25, 50, 100 mg, filmomhulde tabletten RVG 126947-51-52 20220713 1.3.1.3 Bijsluiter Juli 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIMLERID 25 MG, FILMOMHULDE TABLETTEN SIMLERID 50 MG, FILMOMHULDE TABLETTEN SIMLERID 100 MG, FILMOMHULDE TABLETTEN Sitagliptin 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What {[Nationally completed name]} is and what it is used for 2. What you need to know before you take {[Nationally completed name]} 3. How to take {[Nationally completed name]} 4. Possible side effects 5. How to store {[Nationally completed name]} 6. Contents of the pack and other information 1. WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR {[Nationally completed name]} contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed 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 other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already 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 b Διαβάστε το πλήρες έγγραφο
Sandoz B.V. Page 1/21 Simlerid 25, 50, 100 mg, filmomhulde tabletten RVG 126947-51-52 1311-V5 1.3.1.1 Summary of Product Characteristics April 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Simlerid 25 mg, filmomhulde tabletten Simlerid 50 mg, filmomhulde tabletten Simlerid 100 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION {[NATIONALLY COMPLETED NAME] 25 MG FILM-COATED TABLETS}: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg sitagliptin. {[NATIONALLY COMPLETED NAME] 50 MG FILM-COATED TABLETS}: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg sitagliptin. _ _ {[NATIONALLY COMPLETED NAME] 100 MG FILM-COATED TABLETS}: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. {[NATIONALLY COMPLETED NAME] 25 MG FILM-COATED TABLETS}: Pink, round, biconvex film-coated tablet debossed with “ST 25” on one side; diameter 5.7 – 6.6 mm. {[NATIONALLY COMPLETED NAME] 50 MG FILM-COATED TABLETS}: Light pink, round, biconvex film-coated tablet debossed with “ST 50” on one side; diameter 7.7 – 8.6 mm. {[NATIONALLY COMPLETED NAME] 100 MG FILM-COATED TABLETS}: Light brown, round, biconvex film-coated tablet debossed with “ST 100” on one side; diameter 9.7 – 10.6 mm. 4. CLINICAL PARTICULARS Sandoz B.V. Page 2/21 Simlerid 25, 50, 100 mg, filmomhulde tabletten RVG 126947-51-52 1311-V5 1.3.1.1 Summary of Product Characteristics April 2022 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, {[Nationally completed name]} 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 n Διαβάστε το πλήρες έγγραφο