Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; Empagliflozin
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
METFORMIN HYDROCHLORIDE; Empagliflozin
60tablet Tablets; 10tablet Tablets; 30 tablets Tablets
BOEHRINGER INGELHEIM ELLAS A.E
JARDIANCE DUO ® Film-coated tablets Empagliflozin/Metformin (5mg/500mg, 12.5mg/500mg, 12.5mg/850mg & 12.5mg/1000mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Jardiance Duo is used for 2. How Jardiance Duo works 3. Before you use Jardiance Duo 4. How to use Jardiance Duo 5. While you are using it 6. Side effects 7. Storage and Disposal of Jardiance Duo 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial number 1. WHAT JARDIANCE DUO_ _IS USED FOR Jardiance Duo is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus • when treatment with both empagliflozin and metformin is appropriate • inadequately controlled with metformin or empagliflozin alone • inadequately controlled with empagliflozin or metformin in combination with other glucose- lowering products including insulin • already treated with empagliflozin and metformin co-administered as separate tablets Jardiance Duo is used to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established heart (cardiovascular) disease. What is type 2 diabetes? Type 2 diabetes is a disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs. 2. HOW JARDIANCE DUO WORKS Jardiance Duo is a diabetes medicine that contains two active substances called empagliflozin and metformin. • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2). SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys. Aqra d-dokument sħiħ
1 JARDIANCE DUO ® Abcd 1. NAME OF THE MEDICINAL PRODUCT JARDIANCE DUO 5mg/ 500mg film-coated tablets JARDIANCE DUO 12.5mg/ 500mg film-coated tablets JARDIANCE DUO 12.5mg/ 850mg film-coated tablets JARDIANCE DUO 12.5mg/ 1000mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION JARDIANCE DUO 5mg/ 500mg film-coated tablets Each tablet contains 5 mg empagliflozin and 500 mg metformin hydrochloride. JARDIANCE DUO 12.5mg/ 500mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 500 mg metformin hydrochloride. JARDIANCE DUO 12.5mg/ 850mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. JARDIANCE DUO 12.5mg/ 1000mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1000 mg metformin hydrochloride. 3. PHARMACEUTICAL FORM 5mg/ 500mg Orange yellow, oval, biconvex film-coated tablets, one side debossed with Boehringer Ingelheim company symbol and “S5”, the other side is debossed with “500”. 12.5mg/ 500mg Pale brownish purple, oval, biconvex film-coated tablets, one side debossed with Boehringer Ingelheim company symbol and “S12”, the other side is debossed with “500”. 12.5mg/850mg Pinkish white, oval, biconvex film-coated tablets, one side debossed with Boehringer Ingelheim company symbol and “S12”, the other side is debossed with “850”. 12.5mg/ 1000mg Dark brownish purple, oval, biconvex film-coated tablets, one side debossed with Boehringer Ingelheim company symbol and “S12”, the other side is debossed with “1000”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glycaemic control 2 JARDIANCE DUO is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus: - when treatment with both empagliflozin and metformin is appropriate (see CLINICAL TRIALS and POSOLOGY AND METHOD OF ADMINISTRATION ). - Inadequately controlled with metformin or empagliflozin alone - Inadequately controlled with empagliflozin or metformin in combination with o Aqra d-dokument sħiħ