Sitagliptin/Metformin Clonmel 50 mg/1000 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Sitagliptin; Metformin Hydrochloride

Fáanlegur frá:

Clonmel Healthcare Ltd

ATC númer:

A10BD07

INN (Alþjóðlegt nafn):

Sitagliptin; Metformin Hydrochloride

Skammtar:

50 mg/1000 milligram(s)

Lyfjaform:

Film-coated tablet

Lækningarsvæði:

metformin and sitagliptin

Leyfisstaða:

Not marketed

Leyfisdagur:

2021-12-17

Upplýsingar fylgiseðill

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

Vara einkenni

HealthProductsRegulatoryAuthority
15March2024
CRN00F29H
Page1of17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin/MetforminClonmel50mg/1000mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontainssitagliptinhydrochloridemonohydrateequivalentto50
mgofsitagliptinand1,000 mgofmetformin
hydrochloride.
Excipient(s) with known effect
Eachtabletcontains32.5 mgsodium.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet.
Oval-shaped,biconvex,brownfilm-coatedtabletofapproximately21.5mmx10mmandwith"S477"debossedononeside.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foradultpatientswithtype2diabetesmellitus:
Sitagliptin/MetforminClonmel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Clonmel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Clonmel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Clonmelisalsoindicatedasadd-ontoinsulin