Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Sitagliptin; Metformin Hydrochloride
Clonmel Healthcare Ltd
A10BD07
Sitagliptin; Metformin Hydrochloride
50 mg/850 milligram(s)
Film-coated tablet
metformin and sitagliptin
Not marketed
2021-12-17
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN CLONMEL 50 MG/850 MG FILM-COATED TABLETS SITAGLIPTIN/METFORMIN CLONMEL 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 Clonmel is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin Clonmel 3. How to take Sitagliptin/Metformin Clonmel 4. Possible side effects 5. How to store Sitagliptin/Metformin Clonmel 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN CLONMEL IS AND WHAT IT IS USED FOR Sitagliptin/Metformin Clonmel 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, and the insulin that your body produces does not work Lire le document complet
HealthProductsRegulatoryAuthority 15March2024 CRN00F29H Page1of17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sitagliptin/MetforminClonmel50mg/850mgfilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachtabletcontainssitagliptinhydrochloridemonohydrateequivalentto50 mgofsitagliptinand850 mgofmetformin hydrochloride. Excipient(s) with known effect Eachtabletcontains27.6 mgsodiumand13.7 mglactose(asmonohydrate). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. Oval-shaped,biconvex,pinkfilm-coatedtabletofapproximately20.5mmx9.5mmandwith"S476"debossedononeside. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foradultpatientswithtype2diabetesmellitus: Sitagliptin/MetforminClonmelisindicatedasanadjuncttodietandexercisetoimproveglycaemiccontrolinpatients inadequatelycontrolledontheirmaximaltolerateddoseofmetforminaloneorthosealreadybeingtreatedwiththe combinationofsitagliptinandmetformin. Sitagliptin/MetforminClonmelisindicatedincombinationwithasulphonylurea(i.e.,triplecombinationtherapy)asanadjunct todietandexerciseinpatientsinadequatelycontrolledontheirmaximaltolerateddoseofmetforminandasulphonylurea. Sitagliptin/MetforminClonmelisindicatedastriplecombinationtherapywithaperoxisomeproliferator-activatedreceptor gamma(PPARγ)agonist(i.e.,athiazolidinedione)asanadjuncttodietandexerciseinpatientsinadequatelycontrolledontheir maximaltolerateddoseofmetforminandaPPARγagonist. Sitagliptin/MetforminClonmelisalso Lire le document complet