Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Sitagliptin Hydrochloride
Pinewood Laboratories Ltd
A10BH01
Sitagliptin Hydrochloride
Film-coated tablet
sitagliptin
Marketed
2022-04-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN PINEWOOD 25 MG FILM-COATED TABLETS SITAGLIPTIN PINEWOOD 50 MG FILM-COATED TABLETS SITAGLIPTIN PINEWOOD 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, 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 Pinewood is and what it is used for 2. What you need to know before you take Sitagliptin Pinewood 3. How to take Sitagliptin Pinewood 4. Possible side effects 5. How to store Sitagliptin Pinewood 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN PINEWOOD IS AND WHAT IT IS USED FOR Sitagliptin Pinewood 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 Przeczytaj cały dokument
HealthProductsRegulatoryAuthority 08April2022 CRN009TNF Page1of14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SitagliptinPinewood50mgfilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachtabletcontainssitagliptinhydrochloridemonohydrate,equivalentto50 mgofsitagliptin. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet(tablet). SitagliptinPinewood50 mgfilm-coatedtablets:Round-shaped,biconvex,film-coatedtabletsapproximately8 mmdiameter, orange,debossedwith"C"ononesideandplainontheother. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foradultpatientswithtype2diabetesmellitus,SitagliptinPinewood50 mgisindicatedtoimproveglycaemiccontrol:as monotherapy inpatientsinadequatelycontrolledbydietandexercisealoneandforwhommetforminisinappropriatedueto contraindicationsorintolerance. asdualoraltherapyincombinationwith metforminwhendietandexerciseplusmetforminalonedonotprovideadequateglycaemiccontrol. asulphonylureawhendietandexerciseplusmaximaltolerateddoseofasulphonylureaalonedonotprovide adequateglycaemiccontrolandwhenmetforminisinappropriateduetocontraindicationsorintolerance. aperoxisomeproliferator-activatedreceptorgamma(PPARγ)agonist(i.e.athiazolidinedione)whenuseofa PPARγagonistisappropriateandwhendietandexerciseplusthePPARγagonistalonedonotprovideadequate glycaemiccontrol. astripleoraltherapyincombinationwith asulphonylureaandmetforminwhendietandexerciseplusdualther Przeczytaj cały dokument