Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
sitagliptin
Merck Sharp & Dohme B.V.
A10BH01
sitagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: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 when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination witha sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.
Revision: 28
Authorised
2008-01-10
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORM ATION FOR THE PATIENT TESAVEL 25 MG FILM- COATED TABLETS TESAVEL 50 MG FILM-COATED TABLETS TESAVEL 100 MG FILM-COATED TABLETS sitagliptin READ ALL OF THIS LEAFLET CAREFULLY B EFORE YOU START TA KING 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 doct or, pharmacist, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, e ven if their s igns of illness are the same as yours. - If you get any side effects , tal k to your doc tor, pharma cist, or nurse. This incl udes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tesavel is an d what it is used for 2. What you need to know b efore you take Tesavel 3. How to take Tesavel 4. Possible side effects 5. How to store Tesavel 6. Contents of the pack and other information 1. WHAT TESAVEL IS AND WHAT IT IS USED FOR Tesavel contains the active substance sitagliptin which is a member of a class of med i cines called DPP-4 in hibitors (dip eptidyl peptidase- 4 inhibitors) that lowers bl ood sugar level s in adult patients with type 2 diabetes mellitus . This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body. Y our doctor ha s prescribed this medicine to help lower your blood sugar, wh ich is too high because of your type 2 diabetes. This medicine can be used alone or i n combinati on with certain other medicines (insulin, metformin, sulphonylur e as, or glitazones) th at lower bloo d suga r, which you may already be taking for y our diabetes to gether with a fo od and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition i n which your body does not make enough insulin, and the insulin that your body produce s does not wo rk as well as it should. Your body c an also ma ke too much sug ar. When this ha ppens, sugar (glucose Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tesavel 25 mg film- coated tablet s Tesavel 50 mg film- coated tablet s Tesavel 100 mg film- coated tablet s 2. QUALITATIV E AND QUANTITATIVE COMPOSIT ION Tesavel 25 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin. Tesavel 50 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin . Tesavel 100 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin . For the full list of excipients, s ee section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Tesavel 25 mg film-coated tablets Rou nd, pink film - coated tablet with “221” on one side. Tesavel 50 mg film- coated tablets Round, light beige film - coated table t with “112” on one side . Tesavel 100 mg film- coated tablets Round, beige f ilm- coated tablet wi th “277” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: • in patients inadequately controlled by diet and exercise alone and for whom metformin is inapp ropriate due to contraindications or intolerance. as dual oral t herapy in combination with : • metformin when diet and exercise plus metformin alone d o not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal tolerated do se of a sulphonylurea alone do not provide adequate glycaemic co nt rol and when metformin is inappropriate due to contraindications or intolerance. 3 • a peroxisome proliferator - activated receptor gamma ( PPAR ) agonist (i.e. a thiazolidine dione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control. as triple oral thera py in combination with : • a sulphonylurea and metformin when diet and ex Lestu allt skjalið