Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
vildagliptin
Medochemie Ltd
A10BH02
vildagliptin
50 mg
Tablett
vildagliptin 50 mg Aktiv substans; laktos (vattenfri) Hjälpämne
Receptbelagt
Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 112 tabletter; Blister, 180 tabletter; Blister, 336 tabletter
Godkänd
2017-07-20
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DALMEVIN 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 diabetes 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dalmevin is and what it is used for 2. What you need to know before you take Dalmevin 3. How to take Dalmevin 4. Possible side effects 5. How to store Dalmevin 6. Contents of the pack and other information 1. WHAT DALMEVIN IS AND WHAT IT IS USED FOR The active substance of Dalmevin, vildagliptin, belongs to a group of medicines called “oral antidiabetics”. Dalmevin 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 Dalmevin 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 DALMEVIN WORKS Dalmevin works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dalmevin 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin. Excipient with known effect: each tablet contains 48 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to light yellowish, round flat bevel edged uncoated tablet plain on both sides with diameter 8mm. 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 vildagliptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. 2 The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione ha Read the complete document