Sitagliptine +pharma 25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE

INN (Algemene Internationale Benaming):

SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-19

Bijsluiter

1
Version 1.3
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTINE +PHARMA 25 MG, FILMOMHULDE TABLETTEN
SITAGLIPTINE +PHARMA 50 MG, FILMOMHULDE TABLETTEN
SITAGLIPTINE +PHARMA 100 MG, FILMOMHULDE TABLETTEN
sitagliptine
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product 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 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 sug

Productkenmerken

1
Version 1.4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptine +pharma 25 mg, filmomhulde tabletten
Sitagliptine +pharma 50 mg, filmomhulde tabletten
Sitagliptine +pharma 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 25 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 25 mg sitagliptin.
[Product name] 50 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 50 mg sitagliptin.
[Product name] 100 mg film-coated tablets
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).
[Product name] 25 mg film-coated tablets
Round, pink film-coated tablet with engraved “25” on one side with
dimensions 6.2 ± 0.2mm
[Product name] 50 mg film-coated tablets
Round, light beige, film-coated tablet with engraved “50” on one
side with dimensions 8.0 ± 0.2mm
[Product name] 100 mg film-coated tablets
Round, beige, film-coated tablet with engraved “100” on one side
with dimensions 9.9 ± 0.2 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, [Product 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 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 (PPAR
γ
) agonist (i.e. a thiazolidinedione) when
use of a PPAR
γ
agonist is appropriate and when diet an