Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
vildagliptin
Novartis Europharm Limited
A10BH02
vildagliptin
Dipeptidyl peptidase 4 (DPP-4) inhibitors, Drugs used in diabetes
Diabetes Mellitus, Type 2
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).
Revision: 24
Authorised
2008-11-19
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER JALRA 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 Jalra is and what it is used for 2. What you need to know before you take Jalra 3. How to take Jalra 4. Possible side effects 5. How to store Jalra 6. Contents of the pack and other information 1. WHAT JALRA IS AND WHAT IT IS USED FOR The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”. Jalra is used to treat 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 Jalra 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 which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances. HOW JALRA WORKS Jalra works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been sh Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jalra 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin. Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet. One side is debossed with “NVR”, and the other side with “FB”. 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 a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening. When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily. When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. Doses higher than 100 mg are not recommended. If a dose of Jalra is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. 3 The safety and efficacy of vildagliptin as tripl Pročitajte cijeli dokument