Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; Dapagliflozin Propanediol
ASTRAZENECA SDN. BHD.
METFORMIN HYDROCHLORIDE; Dapagliflozin Propanediol
28tablet Tablets; 7tablet Tablets
AstraZeneca Pharmaceuticals LP
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XIGDUO ® XR TABLET _ _ Dapagliflozin/Metformin Hydrochloride (5/1000 mg, 10/500 mg & 10/1000 mg) 1 WHAT IS IN THIS LEAFLET 1. What XIGDUO XR is used for 2. How XIGDUO XR works 3. Before you use XIGDUO XR 4. How to use XIGDUO XR 5. While you are using it 6. Side effects 7. Storage and disposal of XIGDUO XR 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT XIGDUO XR IS USED FOR XIGDUO XR is a prescription medicine used with diet, exercise and sometimes other medicines such as insulin, a sulfonylurea, or a dipeptidyl peptidase (DPP-4) inhibitor to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus. Dapagliflozin can also reduce hospitalisation for heart failure in patients with type 2 diabetes. TYPE 2 DIABETES MELLITUS Type 2 diabetes mellitus (also called non-insulin-dependent diabetes mellitus, or NIDDM) is the condition of having high levels of blood sugar (hyperglycaemia). This is usually because your body does not make enough insulin and/or the insulin that your body produces does not work as well as it should. Left uncontrolled, the build-up of high levels of sugar in your blood can lead to serious medical problems. The main goal of treating type 2 diabetes is to control your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, which include kidney disease, blindness and amputation. HOW XIGDUO XR WORKS XIGDUO XR contains two active ingredients, dapagliflozin and metformin hydrochloride. Dapagliflozin is a member of a class of medicines you take by mouth called SGLT-2 (Sodium Glucose Cotransporter-2) inhibitors and metformin belongs to a class of medicines called biguanides. Dapagliflozin and metformin work together to lower blood sugar levels in patients with type 2 diabetes mellitus. YOUR DOCTOR MAY HAVE PRESCRIBED THIS MEDICINE FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICIN Aqra d-dokument sħiħ
1 (46) XIGDUO ® XR dapagliflozin propanediol monohydrate/metformin hydrochloride 1 NAME OF THE MEDICINE XIGDUO XR (dapagliflozin propanediol monohydrate/metformin hydrochloride) modified release tablets contain two oral antihyperglycaemic drugs used in the management of type 2 diabetes: dapagliflozin propanediol monohydrate and metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DAPAGLIFLOZIN Dapagliflozin drug substance is a white to off-white powder, is non-hygroscopic, crystalline. Dapagliflozin is non-ionisable; thus, its aqueous solubility and partition coefficient are not affected by changes in pH. Dapagliflozin is a Biopharmaceutical Classification System (BCS) Class III drug. METFORMIN HYDROCHLORIDE Metformin hydrochloride is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. XIGDUO XR XIGDUO XR is available for oral administration as tablets containing the following active ingredients: • XIGDUO XR 10/500: 10 mg dapagliflozin (as dapagliflozin propanediol monohydrate) and 500 mg metformin hydrochloride. • XIGDUO XR 10/1000: 10 mg dapagliflozin (as dapagliflozin propanediol monohydrate) and 1000 mg metformin hydrochloride. • XIGDUO XR 5/1000: 5 mg dapagliflozin (as dapagliflozin propanediol monohydrate) and 1000 mg metformin hydrochloride. Each film-coated tablet of XIGDUO XR contains the following inactive ingredients: carmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, lactose, crospovidone, silicon dioxide, polyvinyl alcohol, macrogol 3350, titanium dioxide, purified talc, iron oxide red CI77491 (XIGDUO XR 10/500 and XIGDUO XR 5/1000 tablets), iron oxide yellow CI77492 (XIGDUO XR 10/1000 tablets). 3 PHARMACEUTICAL FORM • XIGDUO XR 10/500 (dapagliflozin 10 mg /metformin HCl extended release 500 mg) tablets are pink bicon Aqra d-dokument sħiħ