Sitagliptin Rowa 50 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Sitagliptin

Disponible desde:

Rowa Pharmaceuticals Limited

Código ATC:

A10BH01

Designación común internacional (DCI):

Sitagliptin

Dosis:

50 milligram(s)

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

sitagliptin

Estado de Autorización:

Marketed

Fecha de autorización:

2021-10-08

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN ROWA 25 MG FILM-COATED TABLETS
SITAGLIPTIN ROWA 50 MG FILM-COATED TABLETS
SITAGLIPTIN ROWA 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 Rowa
is and what it is used for
2.
What you need to know before you take Sitagliptin Rowa
3.
How to take Sitagliptin Rowa
4.
Possible side effects
5.
How to store Sitagliptin Rowa
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN ROWA IS AND WHAT IT IS USED FOR
Sitagliptin Rowa
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
also make too much sugar.
When this

Ficha técnica

HealthProductsRegulatoryAuthority
11October2022
CRN00D4ZD
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SitagliptinRowa50mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontainssitagliptinhydrochloridemonohydrateequivalentto50mgsitagliptin.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet(tablet).
Round-shaped,biconvex,film-coatedtabletsapproximately8mmdiameter,orange,debossedwith"C"ononesideandplain
ontheother.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foradultpatientswithtype2diabetesmellitus,SitagliptinRowaisindicatedtoimproveglycaemiccontrol:asmonotherapy

inpatientsinadequatelycontrolledbydietandexercisealoneandforwhommetforminisinappropriatedueto
contraindicationsorintolerance.
asdualoraltherapyincombinationwith

metforminwhendietandexerciseplusmetforminalonedonotprovideadequateglycaemiccontrol.

asulphonylureawhendietandexerciseplusmaximaltolerateddoseofasulphonylureaalonedonotprovide
adequateglycaemiccontrolandwhenmetforminisinappropriateduetocontraindicationsorintolerance.

aperoxisomeproliferator-activatedreceptorgamma(PPARγ)agonist(i.e.athiazolidinedione)whenuseofa
PPARγagonistisappropriateandwhendietandexerciseplusthePPARγagonistalonedonotprovideadequate
glycaemiccontrol.
astripleoraltherapyincombinationwith

asulphonylureaandmetforminwhendietandexerciseplusdualtherapywiththesemedicinalproductsdonot
provide�