Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Sitagliptin Hydrochloride; Metformin Hydrochloride
Pinewood Laboratories Ltd
A10BD07
Sitagliptin Hydrochloride; Metformin Hydrochloride
Film-coated tablet
metformin and sitagliptin
Marketed
2023-06-23
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN HYDROCHLORIDE PINEWOOD 50 MG/850 MG FILM-COATED TABLETS SITAGLIPTIN/METFORMIN HYDROCHLORIDE PINEWOOD 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 Pinewood is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin Hydrochloride Pinewood 3. How to take Sitagliptin/Metformin Hydrochloride Pinewood 4. Possible side effects 5. How to store Sitagliptin/Metformin Hydrochloride Pinewood 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE PINEWOOD IS AND WHAT IT IS USED FOR Sitagliptin/Metformin Hydrochloride Pinewood 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 Les hele dokumentet
Health Products Regulatory Authority 21 December 2023 CRN00DZGS Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sitagliptin/Metformin Hydrochloride Pinewood 50 mg/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 (tablet). Sitagliptin/Metformin Hydrochloride Pinewood 50 mg/1000 mg film-coated tablets: Oval-shaped, biconvex, film-coated tablets approximately 21.5 mm x 10.0 mm, brown, debossed with "S477" on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin Hydrochloride Pinewood 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 Pinewood 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 Pinewood 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 Pinewood 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 P Les hele dokumentet