البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
empagliflozin, metformin
Boehringer Ingelheim
A10BD20
empagliflozin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Synjardy is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients inadequately controlled on their maximally tolerated dose of metformin alone;in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
Revision: 26
Authorised
2015-05-27
66 B. PACKAGE LEAFLET 67 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYNJARDY 5 MG/850 MG FILM-COATED TABLETS SYNJARDY 5 MG/1,000 MG FILM-COATED TABLETS SYNJARDY 12.5 MG/850 MG FILM-COATED TABLETS SYNJARDY 12.5 MG/1,000 MG FILM-COATED TABLETS empagliflozin/metformin hydrochloride 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Synjardy is and what it is used for 2. What you need to know before you take Synjardy 3. How to take Synjardy 4. Possible side effects 5. How to store Synjardy 6. Contents of the pack and other information 1. WHAT SYNJARDY IS AND WHAT IT IS USED FOR WHAT SYNJARDY IS Synjardy contains two active substances empagliflozin and metformin. Each belongs to a group of medicines called “oral anti-diabetics”. These are medicines taken by mouth to treat type 2 diabetes. 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. HOW SYNJARDY WORKS Empagliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Metformin اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride. Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride. Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Synjardy 5 mg/850 mg film-coated tablets Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). Synjardy 5 mg/1,000 mg film-coated tablets Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). Synjardy 12.5 mg/850 mg film-coated tablets Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). Synjardy 12.5 mg/1,000 mg film-coated tablets Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise: i اقرأ الوثيقة كاملة