Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Dapagliflozin
KRKA, d.d., Novo mesto
A10BK01
Dapagliflozin
Film-coated tablet
Dapagliflozin
Not marketed
2023-12-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAPAGLIFLOZIN KRKA 5 MG FILM-COATED TABLETS DAPAGLIFLOZIN KRKA 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 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 Dapagliflozin Krka is and what it is used for 2. What you need to know before you take Dapagliflozin Krka 3. How to take Dapagliflozin Krka 4. Possible side effects 5. How to store Dapagliflozin Krka 6. Contents of the pack and other information 1. WHAT DAPAGLIFLOZIN KRKA IS AND WHAT IT IS USED FOR WHAT DAPAGLIFLOZIN KRKA IS Dapagliflozin Krka 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 KRKA IS USED FOR Dapagliflozin Krka 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 Krka 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 DAPAGLIFLOZIN Prečítajte si celý dokument
Health Products Regulatory Authority 01 December 2023 CRN00CW3K Page 1 of 31 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dapagliflozin Krka 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg dapagliflozin (from dapagliflozin propanediol monohydrate form). Excipient with known effect: Each film-coated tablet contains 48.7 mg lactose. _ _ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Light brownish yellow, round, biconvex, film-coated tablets, marked with "5" on one side. Tablet dimension: diameter approx. 7 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type 2 diabetes mellitus Dapagliflozin Krka 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 Dapagliflozin Krka is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Dapagliflozin Krka 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 insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8). _Heart failure_ Health Products Regulatory Authority 01 December 2023 CRN00CW3K Page 2 of 31 The recommended dose is 10 mg dapagliflozin once daily. _Chronic kidney disease_ The recommended dos Prečítajte si celý dokument