מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Dapagliflozin Propanediol
ASTRAZENECA SDN. BHD.
Dapagliflozin Propanediol
28 Tablets; 28 Tablets; 30 Tablets
AstraZeneca Pharmaceuticals LP
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FORXIGA ® FILM-COATED TABLET DAPAGLIFLOZIN (5MG AND 10MG) 1 WHAT IS IN THIS LEAFLET 1. What Forxiga is used for 2. How Forxiga works 3. Before you use Forxiga 4. How to use Forxiga 5. While you are using it 6. Side effects 7. Storage and Disposal of Forxiga 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT FORXIGA IS USED FOR Forxiga is used in adult patients (aged 18 years and older) to treat: • Type 2 diabetes mellitus 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. • Heart failure when the heart does not pump blood as well as it should. • Chronic kidney disease with reduced kidney function. HOW FORXIGA WORKS 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 is 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 it produces properly. This leads to a high level of sugar in your blood, which can lead to serious medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs. Forxiga works by removing excess sugar from your body. It can also help prevent heart disease. _What is heart failure and how does _ _Forxiga help? _ This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as well as it should. This can lead to serious medical problems and need for hospital care. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling. Forxiga helps protect your heart from getting worse and improves your symptoms. It can lower t קרא את המסמך השלם
1 FORXIGA ® 5 MG & 10 MG FILM-COATED TABLETS DAPAGLIFLOZIN 1. NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg or 10 mg of dapagliflozin. _ _ _Excipient with known effect: _ Each tablet contains 25 mg or 50 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 5 mg: Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. 10 mg: 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 aged 18 years and older with type 2 diabetes mellitus as: MONOTHERAPY When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. ADD-ON COMBINATION THERAPY In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). INITIAL COMBINATION 2 Forxiga is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when diet and exercise have failed to provide adequate glycemic control and there are poor prospects for response to metformin monotherapy (for example, high initial HbA 1c levels). To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. For study results with respect to combination of th קרא את המסמך השלם