Država: Malta
Jezik: engleski
Izvor: Medicines Authority
VILDAGLIPTIN, METFORMIN HYDROCHLORIDE
Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain
A10BD08
VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg
FILM-COATED TABLET
VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-01-11
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VILDAGLIPTIN/METFORMIN GALENICUM 50 MG/850 MG FILM-COATED TABLETS VILDAGLIPTIN/METFORMIN GALENICUM 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 is and what it is used for 2. What you need to know before you take Vildagliptin/Metformin 3. How to take Vildagliptin/Metformin 4. Possible side effects 5. How to store Vildagliptin/Metformin 6. Contents of the pack and other information 1. WHAT VILDAGLIPTIN/METFORMIN IS AND WHAT IT IS USED FOR The active substances of Vildagliptin/Metformin, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Vildagliptin/Metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as noninsulin- dependent diabetes mellitus. Vildagliptin/Metformin 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/METFORMIN WORKS Both a Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Vildaglptin/Metformin Galenicum 50/850mg and 50/1000mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vildagliptin/Metformin 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 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 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. Table length: 19.4 0.5 mm The score line is not intended for breaking the tablet. Vildagliptin/Metformin 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. Table 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 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 _Adults with normal renal function (GFR _ _≥ _ _90 ml/mi Pročitajte cijeli dokument