Simlerid 25 mg, filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv ingrediens:

SITAGLIPTINEHYDROCHLORIDE 1-WATER 28,3 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 25 mg/stuk

Tilgjengelig fra:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (International Name):

SITAGLIPTINEHYDROCHLORIDE 1-WATER 28,3 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 25 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Administreringsrute:

Oraal gebruik

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

Sandoz B.V.
Page 1/7
Simlerid 25, 50, 100 mg, filmomhulde tabletten
RVG 126947-51-52
20220713
1.3.1.3 Bijsluiter
Juli 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMLERID 25 MG, FILMOMHULDE TABLETTEN
SIMLERID 50 MG, FILMOMHULDE TABLETTEN
SIMLERID 100 MG, FILMOMHULDE TABLETTEN
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 {[Nationally completed name]} is and what it is used for
2.
What you need to know before you take {[Nationally completed name]}
3.
How to take {[Nationally completed name]}
4.
Possible side effects
5.
How to store {[Nationally completed name]}
6.
Contents of the pack and other information
1.
WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} 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 b

Preparatomtale

Sandoz B.V.
Page 1/21
Simlerid 25, 50, 100 mg, filmomhulde tabletten
RVG 126947-51-52
1311-V5
1.3.1.1 Summary of Product Characteristics
April 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Simlerid 25 mg, filmomhulde tabletten
Simlerid 50 mg, filmomhulde tabletten
Simlerid 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[NATIONALLY COMPLETED NAME] 25 MG FILM-COATED TABLETS}:
Each
film-coated
tablet
contains
sitagliptin
hydrochloride
monohydrate
equivalent
to
25
mg
sitagliptin.
{[NATIONALLY COMPLETED NAME] 50 MG FILM-COATED TABLETS}:
Each
film-coated
tablet
contains
sitagliptin
hydrochloride
monohydrate
equivalent
to
50
mg
sitagliptin.
_ _
{[NATIONALLY COMPLETED NAME] 100 MG FILM-COATED TABLETS}:
Each
film-coated
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.
{[NATIONALLY COMPLETED NAME] 25 MG FILM-COATED TABLETS}:
Pink, round, biconvex film-coated tablet debossed with “ST 25” on
one side; diameter 5.7 – 6.6 mm.
{[NATIONALLY COMPLETED NAME] 50 MG FILM-COATED TABLETS}:
Light pink, round, biconvex film-coated tablet debossed with “ST
50” on one side; diameter 7.7 – 8.6
mm.
{[NATIONALLY COMPLETED NAME] 100 MG FILM-COATED TABLETS}:
Light brown, round, biconvex film-coated tablet debossed with “ST
100” on one side; diameter 9.7 –
10.6 mm.
4.
CLINICAL PARTICULARS
Sandoz B.V.
Page 2/21
Simlerid 25, 50, 100 mg, filmomhulde tabletten
RVG 126947-51-52
1311-V5
1.3.1.1 Summary of Product Characteristics
April 2022
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, {[Nationally
completed name]} 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 n