Sitagliptin Teva 100 mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Sitagliptin

Beschikbaar vanaf:

Teva B.V.

ATC-code:

A10BH; A10BH01

INN (Algemene Internationale Benaming):

Sitagliptin

Dosering:

100 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Dipeptidyl peptidase 4 (DPP-4) inhibitors; sitagliptin

Autorisatie-status:

Not marketed

Autorisatie datum:

2016-09-02

Bijsluiter

Sitagliptin, DE/H/4327/001-003, 15.11.22
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
25 MG FILM-COATED TABLETS
50 MG FILM-COATED TABLETS
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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
h

Productkenmerken

Health Products Regulatory Authority
20 March 2023
CRN00D5N8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin Teva 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin malate, equivalent to 100 mg
sitagliptin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Brown to orange, round shaped film-coated tablet. One side is scored
and debossed with “S|100”. The other side is scored.
Dimensions: Diameter approx. 9.7 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_For adult patients with type 2 diabetes mellitus,_ Sitagliptin Teva_
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 adequate glycaemic control.
Health Products Regulatory Authority
20 March 2023
CRN00D5N8
Page 2 of 13

a PPARγ agonist and metformin when use of a PPARγ agonist is
appropriate and when diet and exercise plus dual
therapy with these medicinal products do not provide adequate
glycaemic control.
Sitagliptin Teva is also indicated as add-on t