Sitagliptin Pinewood 100 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Sitagliptin Hydrochloride

Tillgänglig från:

Pinewood Laboratories Ltd

ATC-kod:

A10BH01

INN (International namn):

Sitagliptin Hydrochloride

Läkemedelsform:

Film-coated tablet

Terapiområde:

sitagliptin

Bemyndigande status:

Marketed

Tillstånd datum:

2022-04-08

Bipacksedel

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

Produktens egenskaper

HealthProductsRegulatoryAuthority
08April2022
CRN009TNF
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SitagliptinPinewood100mgfillm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontainssitagliptinhydrochloridemonohydrate,equivalentto100
mgsitagliptin.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet(tablet).
SitagliptinPinewood100
mgfilm-coatedtablets:Round-shaped,biconvex,film-coatedtabletsapproximately9.8
mmdiameter,
beige,debossedwith"L"ononesideandplainontheother.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foradultpatientswithtype2diabetesmellitus,SitagliptinPinewood100
mg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therap