Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
sitagliptinfosfatmonohydrat
Medochemie Ltd
A10BH01
sitagliptin phosphate monohydrate
50 mg
Filmdragerad tablett
sitagliptinfosfatmonohydrat 64,25 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 98 tabletter
Godkänd
2017-08-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JIMANDIN 25 MG FILM-COATED TABLETS JIMANDIN 50 MG FILM-COATED TABLETS JIMANDIN 100 MG FILM-COATED TABLETS Sitagliptin 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 or pharmacist. - 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 Jimandin is and what it is used for 2. What you need to know before you take Jimandin 3. How to take Jimandin 4. Possible side effects 5. How to store Jimandin 6. Contents of the pack and other information 1. WHAT JIMANDIN IS AND WHAT IT IS USED FOR Jimandin contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan. 2 WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart di Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Jimandin 25 mg film-coated tablets Jimandin 50 mg film-coated tablets Jimandin 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Jimandin 25 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25mg sitagliptin. Each Jimandin 50 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin. Each Jimandin 100 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25 mg/tablet: Yellow round, biconvex film coated tablets, with diameter approximately 6mm 50 mg/tablet: Pale red round, biconvex film coated tablets, with diameter approximately 8mm 100 mg/tablet: Light brown, round, biconvex film coated tablets with diameter approximately 10.3mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, Jimandin 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 peroxisome proliferator-activated receptor gamma (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 with • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Läs hela dokumentet