Kraj: Malta
Język: angielski
Źródło: Medicines Authority
Pharmacare Srl Via Marghera, 29 20149, Milan, Italy
A10BH02
VILDAGLIPTIN 50 mg
TABLET
VILDAGLIPTIN 50 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-30
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER VILDAGLIPTIN PHARMACARE 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 Pharmacare is and what it is used for 2. What you need to know before you take Vildagliptin Pharmacare 3. How to take Vildagliptin Pharmacare 4. Possible side effects 5. How to store Vildagliptin Pharmacare 6. Contents of the pack and other information 1. WHAT VILDAGLIPTIN PHARMACARE IS AND WHAT IT IS USED FOR The active substance of Vildagliptin Pharmacare, 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 Pharmacare 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 PHARMACA Przeczytaj cały dokument
Page 1 of 17 1. NAME OF THE MEDICINAL PRODUCT Vildagliptin Pharmacare 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 as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: • as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance • 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_ 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 dose of vildagliptin is 50mg once daily administered in the morning. In this patient population, vildagliptin 100mg daily was no more effective than vildagliptin 50mg once daily. When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. 2 Doses higher than 100 mg are not recommended. If a dose of Vildagliptin Pharmacare is missed, it should be taken as soon as the patient remember. A double dose should not be taken on the same day. The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. Przeczytaj cały dokument