Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sitagliptin Hydrochloride; Metformin Hydrochloride
Rowex Ltd
A10BD07
Sitagliptin Hydrochloride; Metformin Hydrochloride
50/1000 milligram(s)
Film-coated tablet
metformin and sitagliptin
Not marketed
2021-03-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWEX 50 MG/850 MG FILM-COATED TABLETS SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWEX 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, pharmacist or 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sitagliptin/Metformin hydrochloride Rowex is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin hydrochloride Rowex 3. How to take Sitagliptin/Metformin hydrochloride Rowex 4. Possible side effects 5. How to store Sitagliptin/Metformin hydrochloride Rowex 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWEX IS AND WHAT IT IS USED FOR Sitagliptin/Metformin hydrochloride Rowex 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 Read the complete document
Health Products Regulatory Authority 05 March 2021 CRN009CX5 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sitagliptin/Metformin hydrochloride Rowex 50/1000 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Light red film-coated tablet of oval, biconvex shape (approximately 10.5x21 mm), debossed with "SM 3" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Rowex 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 Rowex 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 Rowex 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 Rowex 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 anti-hyperglycaemic therapy with Sitagliptin/Metformin hydrochloride Rowex should be individualised on the basis of Read the complete document