Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
dapagliflozin propanediol monohydrate
AstraZeneca AB
A10BK01
dapagliflozin
Drugs used in diabetes
Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Type 2 diabetes mellitusForxiga 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 exerciseas 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 failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.
Revision: 29
Authorised
2012-11-11
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FORXIGA 5 MG FILM-COATED TABLETS FORXIGA 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 Forxiga is and what it is used for 2. What you need to know before you take Forxiga 3. How to take Forxiga 4. Possible side effects 5. How to store Forxiga 6. Contents of the pack and other information 1. WHAT FORXIGA IS AND WHAT IT IS USED FOR WHAT FORXIGA IS Forxiga 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 FORXIGA IS USED FOR Forxiga 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. - Forxiga 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) when the heart does not pump blood as well as it should. CHRONIC KIDNEY DISEASE - in adults with reduced kidney function. WHAT IS TYPE 2 DIABETES AND HOW DOES FORXIGA HELP? In type 2 diabetes your body does not make enough insulin or is not able to use the insulin i Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Forxiga 5 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. _Excipient with known effect_ Each 5 mg tablet contains 25 mg of lactose. Forxiga 10 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. _Excipient with known effect_ Each 10 mg tablet contains 50 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Forxiga 5 mg film-coated tablets Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. Forxiga 10 mg film-coated tablets Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type 2 diabetes mellitus Forxiga 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 failure Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. 3 Chronic kidney disease Forxiga is indicated in adults for the treatment of chronic kidney disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Type 2 diabetes mellitus_ The recommended dose is 10 mg dapagliflozin once daily. When dapagliflozin is used in combination with Lees het volledige document