Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EMPAGLIFLOZINE 25 mg/stuk
EMPAGLIFLOZINE 25 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Glusod 10 mg filmomhulde tabletten Glusod 25 mg filmomhulde tabletten empagliflozin 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 Glusod is and what it is used for 2. What you need to know before you take Glusod 3. How to take Glusod 4. Possible side effects 5. How to store Glusod 6. Contents of the pack and other information 1. WHAT GLUSOD IS AND WHAT IT IS USED FOR WHAT GLUSOD IS Glusod contains the active substance empagliflozin. Glusod is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. WHAT GLUSOD IS USED FOR TYPE 2 DIABETES MELLITUS • Empagliflozin is used to treat type 2 diabetes in adults and children aged 10 years and older that cannot be controlled by diet and exercise alone. • Empagliflozin can be used without other medicines in patients who cannot take metformin (another diabetes medicine). • Empagliflozin can also be used with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin. Empagliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Thereby empagliflozin lowers the amount of sugar in your blood. This medicine can also help prevent heart disease in patients with type 2 diabetes mellitus. It is important that you continue with your diet and exercise plan as told by your doctor or pharmacist. HEART FAILURE • Empagliflozin is used to treat Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glusod 10 mg filmomhulde tabletten Glusod 25 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GLUSOD 10 mg film-coated tablets Each tablet contains 10 mg empagliflozin. Excipient with known effect: lactose monohydrate. Each tablet contains 59.00 mg lactose monohydrate. GLUSOD 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin. Excipient with known effect: lactose monohydrate. Each tablet contains 147.50 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). GLUSOD 10 mg film-coated tablets Yellow, round, convex, film-coated tablets with dimeter of 6 mm debossed “E” on one side and plain on the other side. GLUSOD 25 mg film-coated tablets Yellow, oval, convex, film-coated tablets with diameter of 11,5 mm x 6,2 mm, debossed “MC” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type 2 diabetes mellitus GLUSOD is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure GLUSOD is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease GLUSOD is indicated in adults for the treatment of chronic kidney disease. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Type 2 diabetes mellitus _ The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes. In patients tolerating empagliflozin 10 mg once d Lees het volledige document