Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sitagliptin
KRKA, d.d., Novo mesto
A10BH01
Sitagliptin
100 milligram(s)
Film-coated tablet
sitagliptin
Marketed
2020-02-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN KRKA 25 MG FILM-COATED TABLETS SITAGLIPTIN KRKA 50 MG FILM-COATED TABLETS SITAGLIPTIN KRKA 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 Sitagliptin Krka is and what it is used for 2. What you need to know before you take Sitagliptin Krka 3. How to take Sitagliptin Krka 4. Possible side effects 5. How to store Sitagliptin Krka 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN KRKA IS AND WHAT IT IS USED FOR Sitagliptin Krka 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 increase the levels of insulin produced 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. 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) b Read the complete document
Health Products Regulatory Authority 08 November 2022 CRN00D697 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sitagliptin Krka 100mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg sitagliptin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets) Brown orange, round, biconvex, film coated tablets with score line on one side of the tablet. Tablet is engraved with mark K on one side of the score line and with mark 100 on the other side of the score line (diameter approx. 11 mm, thickness 3.3 – 4.5 mm). The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, Sitagliptin Krka 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. a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Krka is also indicated as add-o Read the complete document