国家: 马耳他
语言: 英文
来源: Medicines Authority
VILDAGLIPTIN, METFORMIN HYDROCHLORIDE
Bennett Pharmaceuticals SA 16th km Athinon-Lamias Kifisia 14564,, Greece
A10BD08
METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 mg
FILM-COATED TABLET
METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-01-12
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER VILDABEN PLUS 50 MG/850 MG FILM-COATED TABLETS VILDABEN PLUS 50 MG/1000 MG FILM-COATED TABLETS vildagliptin/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 Vildaben plus is and what it is used for 2. What you need to know before you take Vildaben plus 3. How to take Vildaben plus 4. Possible side effects 5. How to store Vildaben plus 6. Contents of the pack and other information 1. WHAT VILDABEN PLUS IS AND WHAT IT IS USED FOR The active substances of Vildaben plus, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Vildaben plus is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. Vildaben plus is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas). Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. HOW VILDABEN PLUS WORKS Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. The substance 阅读完整的文件
Page 1 of 17 1. NAME OF THE MEDICINAL PRODUCT Vildaben plus 50 mg/850 mg and 50 mg/1000 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vildaben plus 50 mg/850 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). Excipient with known effect: Each tablet contains 93.5 mg of lactose Vildaben plus 50 mg/1000 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). Excipient with known effect: Each tablet contains 110 mg of lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Vildaben plus 50 mg/850 mg film-coated tablets Yellow, oblong oval-shaped film-coated tablets with a scoreline on one side and “VA” on the other side. Tablet length: 19.4 ± 0.5 mm The score line is not intended for breaking the tablet. Vildaben plus 50 mg/1000 mg film-coated tablets Dark yellow, oblong oval-shaped film-coated tablets with a scoreline in between ‘V’ and ‘B’ on one side and with a scoreline on the other. . Tablet length: 21.1 ± 0.5 mm The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vildaben plus is indicated as an adjunct to diet and exercise to improve glyceamic control in adults with type 2 diabetes mellitus: - in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Page 2 of 17 _Adults with normal renal function (GFR ≥ 90 ml/min)_ The dose of antihyperglycaemic t 阅读完整的文件