Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Dapagliflozin
CAMBER LABORATORIES SDN. BHD.
Dapagliflozin
2 x 14 Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DAPAZOX (DAPAGLIFLOZIN FILM COATED TABLETS) Dapagliflozin (5mg and 10mg) 1 WHAT IS IN THIS LEAFLET 1. What DAPAZOX _ _ is used for 2. How DAPAZOX _ _ works _3._ _ _ Before you use DAPAZOX _ _ 4. How to use DAPAZOX _ _ 5. While you are using it 6. Side effects 7. Storage and Disposal of DAPAZOX _ _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DAPAZOX_ _IS USED FOR DAPAZOX is used in used in adult patients (aged 18 years and older) to treat: • Type 2 diabetes if your type 2 diabetes cannot be controlled with diet and exercise. DAPAZOX can be used on its own or together with other medicines to treat diabetes. • Heart failure in patients with symptoms due to a weak pump function of the heart. • Chronic kidney disease in patients with reduced kidney function. HOW DAPAZOX_ _WORKS DAPAZOX 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 DAPAZOX _ _help? _ In type 2 diabetes your body does not make enough insulin or is not able to use the insulin it makes properly. This leads to a high level of sugar in your blood. This can lead to serious problems like heart or kidney disease, blindness, and poor circulation in your arms and legs. DAPAZOX works by removing excess sugar from your body. It can also help prevent heart disease. _What _ _is _ _heart _ _failure _ _and _ _how _ _does _ _DAPAZOX help? _ This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. This can lead to serious medical problems and need for hospital care. The most common symptoms of heart failure are feeling breathless, feeling tired or very tired all the time, and ankle swelling. DAPAZOX h Կարդացեք ամբողջական փաստաթուղթը
DAPAZOX 10 (DAPAGLIFLOZIN FILM COATED TABLETS 10MG) DAPAZOX 5 (DAPAGLIFLOZIN FILM COATED TABLETS 5MG) Font size: 7 ACTIVE INGREDIENT DAPAZOX 10 Each film-coated tablet contains 10mg of Dapagliflozin. DAPAZOX 5 Each film-coated tablet contains 5mg of Dapagliflozin. DOSAGE FORM Film-coated tablets PRODUCT DESCRIPTION DAPAZOX 10 Pink, round, biconvex, film-coated tablets debossed with “D33” on one side and “H” on the other side. DAPAZOX 5 Pink, round, biconvex, film-coated tablets debossed with "D32" on one side and "H" on the other side. PHARMACODYNAMICS PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK01. MECHANISM OF ACTION Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2. Inhibition of SGLT2 by dapagliflozin reduces reabsorption of glucose from the glomerular filtrate in the proximal renal tubule with a concomitant reduction in sodium reabsorption leading to urinary excretion of glucose and osmotic diuresis. Dapagliflozin therefore increases the delivery of sodium to the distal tubule which is believed to increase tubuloglomerular feedback and reduce intraglomerular pressure. This combined with osmotic diuresis leads to a reduction in volume overload, reduced blood pressure, and lower preload and afterload, which may have beneficial effects on cardiac remodelling. Other effects include an increase in haematocrit and reduction in body weight. The cardiac benefits of dapagliflozin are not solely dependent on the blood glucose-lowering effect and not limited to patients with diabetes as demonstrated in the DAPA-HF study. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. This glucose excretion (glucuretic effect) is observed after the first dose, is continuous over the 24-hour dosing interval and is sustained for the duration of treatment. The amount of glucose removed b Կարդացեք ամբողջական փաստաթուղթը