Страна: Малта
Език: английски
Източник: Malta Medicines Authority
GAP S.A 46, Agissilaou Street, 17341 Agios Dimitrios, Athens, Greece
A10BD08
VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg
FILM-COATED TABLET
VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-07-20
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VILDAGLIPTIN/METFORMIN GAP 50 MG/850 MG FILM-COATED TABLETS VILDAGLIPTIN/METFORMIN GAP 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 Vildagliptin/Metformin GAP is and what it is used for 2. What you need to know before you take Vildagliptin/Metformin GAP 3. How to take Vildagliptin/Metformin GAP 4. Possible side effects 5. How to store Vildagliptin/Metformin GAP 6. Contents of the pack and other information 1. WHAT VILDAGLIPTIN/METFORMIN GAP IS AND WHAT IT IS USED FOR The active substances of Vildagliptin/Metformin GAP, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Vildagliptin/Metformin GAP is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as noninsulin- dependent diabetes mellitus. Vildagliptin/Metformin GAP 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 VILDAGLIPTIN/ME Прочетете целия документ
1 1. NAME OF THE MEDICINAL PRODUCT Vildagliptin/Metformin GAP 50 mg/850 mg film-coated tablets Vildagliptin/Metformin GAP 50 mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vildagliptin/Metformin GAP 50 mg/850 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 663 mg of metformin). Excipient with known effect: Each tablet contains 93.5 mg of lactose Vildagliptin/Metformin GAP 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. Vildagliptin/Metformin GAP 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. Vildagliptin/Metformin GAP 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 Vildagliptin/Metformin GAP is indicated in 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). 2 4.2 POSOLOGY AND METHOD OF ADMINISTR Прочетете целия документ