Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sitagliptin; Metformin Hydrochloride
KRKA, d.d., Novo mesto
A10BD07
Sitagliptin; Metformin Hydrochloride
50 mg/1000 milligram(s)
Film-coated tablet
metformin and sitagliptin
Marketed
2021-02-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN HYDROCHLORIDE KRKA 50 MG/850 MG FILM-COATED TABLETS SITAGLIPTIN/METFORMIN HYDROCHLORIDE KRKA 50 MG/1000 MG FILM-COATED TABLETS sitagliptin/metformin hydrochloride 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/Metformin hydrochloride Krka is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin hydrochloride Krka 3. How to take Sitagliptin/Metformin hydrochloride Krka 4. Possible side effects 5. How to store Sitagliptin/Metformin hydrochloride Krka 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE KRKA IS AND WHAT IT IS USED FOR Sitagliptin/Metformin hydrochloride Krka contains two different medicines called sitagliptin and metformin. - sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase- 4 inhibitors) - metformin belongs to a class of medicines called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas or glitazones). What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin an Read the complete document
Health Products Regulatory Authority 09 November 2023 CRN00DY9V Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sitagliptin/Metformin hydrochloride Krka 50 mg/1000 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg sitagliptin and 1000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Dark pink, oval, biconvex, film coated tablets marked with C3 on one side of the tablet (dimensions approx.: 21 x 11 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Krka is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride Krka is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride Krka is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. Sitagliptin/Metformin hydrochloride Krka is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of antihyperglycaemic therapy with Sitagliptin/Metformin hydrochloride Krka should be individualised on the basis of the patient's current regimen, effectiven Read the complete document