Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
dapagliflozin
Viatris Limited
A10BK01
dapagliflozin
Drugs used in diabetes
Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Type 2 diabetes mellitusDapagliflozin Viatris 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 type 2 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 failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
Authorised
2023-03-24
55 B. PACKAGE LEAFLET 56 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAPAGLIFLOZIN VIATRIS 5 MG FILM-COATED TABLETS DAPAGLIFLOZIN VIATRIS 10 MG FILM-COATED TABLETS Dapagliflozin 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dapagliflozin Viatris is and what it is used for 2. What you need to know before you take Dapagliflozin Viatris 3. How to take Dapagliflozin Viatris 4. Possible side effects 5. How to store Dapagliflozin Viatris 6. Contents of the pack and other information 1. WHAT DAPAGLIFLOZIN VIATRIS IS AND WHAT IT IS USED FOR WHAT DAPAGLIFLOZIN VIATRIS IS Dapagliflozin Viatris contains the active substance dapagliflozin. It belongs to a group of medicines called ‘sodium glucose co-transporter-2 (SGLT2) inhibitors’. They work by blocking the SGLT2 protein in your kidney. By blocking this protein, blood sugar (glucose), salt (sodium) and water are removed from your body via the urine. WHAT DAPAGLIFLOZIN VIATRIS IS USED FOR Dapagliflozin Viatris is used to treat: • TYPE 2 DIABETES - in adults and children aged 10 years and older. - if your type 2 diabetes cannot be controlled with diet and exercise. - Dapagliflozin Viatris can be used on its own or together with other medicines to treat diabetes. - It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse. • HEART FAILURE - in adults (aged 18 years and older) with symptoms due to a weak pump function of the heart. • CHRONIC KIDNEY DISEASE - in adults with reduce Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dapagliflozin Viatris 5 mg film-coated tablets Dapagliflozin Viatris 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dapagliflozin Viatris 5 mg film-coated tablets Each film-coated tablet contains 5 mg of dapagliflozin. _ _ _Excipient with known effect _ Each 5 mg tablet contains 24 mg of lactose. Dapagliflozin Viatris 10 mg film-coated tablets Each film-coated tablet contains 10 mg of dapagliflozin. _ _ _Excipient with known effect _ Each 10 mg tablet contains 48 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Dapagliflozin Viatris 5 mg film-coated tablet Yellow coloured, round shaped, biconvex film-coated tablet with diameter of approximetely 7.2 mm. Debossed with ‘5’ on one side and plain on the other side. Dapagliflozin Viatris 10 mg film-coated tablet Yellow coloured, diamond shaped, biconvex with dimensions of approximately 11 x 8 mm. Debossed with ‘10’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type 2 diabetes mellitus Dapagliflozin Viatris 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 type 2 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. 3 Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Type 2 diabetes mellitus _ The reco Przeczytaj cały dokument