Sitagliptin/Metformin hydrochloride Rowa 50 mg/850 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sitagliptin Hydrochloride Monohydrate; Metformin Hydrochloride

Available from:

Rowa Pharmaceuticals Limited

ATC code:

A10BD07

INN (International Name):

Sitagliptin Hydrochloride Monohydrate; Metformin Hydrochloride

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

metformin and sitagliptin

Authorization status:

Marketed

Authorization date:

2022-04-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWA 50 MG/850 MG FILM-COATED
TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWA 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 Rowa is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Rowa
3.
How to take Sitagliptin/Metformin hydrochloride Rowa
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Rowa
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE ROWA IS AND WHAT IT IS USED
FOR
Sitagliptin/Metformin
hydrochloride
Rowa
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

Summary of Product characteristics

HealthProductsRegulatoryAuthority
17January2024
CRN00DZ5F
Page1of17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin/MetforminhydrochlorideRowa50mg/850mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontainssitagliptinhydrochlorideequivalentto50mgsitagliptinand850mgmetforminhydrochloride.
Excipient(s) with known
effect:Eachfilm-coatedtabletcontains13.02mgoflactose.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet(tablet).
Oval-shaped,biconvex,film-coatedtabletsapproximately20.5mmx9.5mm,pink,debossedwith"S476"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 Rowa 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Rowa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Rowa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tole