Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
VILDAGLIPTIN
Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain
A10BH02
VILDAGLIPTIN 50 mg
TABLET
VILDAGLIPTIN 50 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-07-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VILDAGLIPTIN ADAIR 50 MG TABLETS Vildagliptin 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 Adair is and what it is used for 2. What you need to know before you take Vildagliptin Adair 3. How to take Vildagliptin Adair 4. Possible side effects 5. How to store Vildagliptin Adair 6. Contents of the pack and other information 1. WHAT VILDAGLIPTIN ADAIR IS AND WHAT IT IS USED FOR The active substance of Vildagliptin Adair , vildagliptin, belongs to a group of medicines called “oral antidiabetics”. Vildagliptin is used to reat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe Vildagliptin Adair either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes. 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. Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance with triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances. HOW VILDAGLIPTIN ADAIR WORKS Vildagliptin Adair works by making the pan Citiți documentul complet
1 _1. _ _NAME OF THE MEDICINAL PRODUCT _ Vildagliptin Adair 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin. Excipient with known effect: Each tablet contains 119.59 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white round biconvex tablets of approximately 8.0 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults: As monotherapy • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. As dual oral therapy in combination with • Metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin, • A sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance, • A thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinendione is appropriate. 2 As triple oral therapy in combination with • A sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequately glycaemic control. Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100mg, administered as one dose of 50mg in the morning and one dose of 50mg in the evening. When used in dual combination with a sulphonylurea, the recommended dos Citiți documentul complet