Sitagliptine/Metformine hydrochloride Genericon 50 mg/850 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE

INN (Algemene Internationale Benaming):

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; SITAGLIPTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2023-02-07

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
SITAGLIPTINE/METFORMINE HYDROCHLORIDE GENERICON 50 MG/850 MG
FILMOMHULDE TABLETTEN
SITAGLIPTINE/METFORMINE HYDROCHLORIDE GENERICON 50 MG/1000 MG
FILMOMHULDE TABLETTEN
sitagliptine/metformin hydrochloride
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 two different medicines called sitagliptin and metformin.
•
sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl
peptidase-4 inhibitors)
•
metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients
with a form of diabetes called
‘type 2 diabetes mellitus’. This medicine helps to increase the
levels of insulin produced after a meal
and lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood
sugar. This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas, or glitazones).
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 t

Productkenmerken

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Sitagliptine/Metformine hydrochloride Genericon 50 mg/850 mg
filmomhulde tabletten
Sitagliptine/Metformine hydrochloride Genericon 50 mg/1000 mg
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 50 mg/850 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 850
mg of metformin hydrochloride.
[Product name] 50 mg/1 000 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and
1 000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
[Product name] 50 mg/850 mg film-coated tablets
Pink, capsule-shaped, biconvex, film-coated tablet of approximately
20.2mm in length, 9.9mm in width
and 7.0mm in thickness, with "585" engraved on one side and break line
on the other side.
[Product name] 50 mg/1 000 mg film-coated tablets
Red, capsule-shaped, biconvex, film-coated tablet of approximately
21.4mm in length, 10.4mm in width
and 7.1mm in thickness, with "5100" engraved on one side and break
line on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
[Product name] is indicated as an adjunct to diet and exercise to
improve glycaemic control in patients
inadequately controlled on their maximal tolerated dose of metformin
alone or those already being
treated with the combination of sitagliptin and metformin.
[Product name] is indicated in combination with a sulphonylurea (i.e.,
triple combination therapy) as
an adjunct to diet and exercise in patients inadequately controlled on
their maximal tolerated dose of
metformin and a sulphonylurea.
[Product name] is indicated as triple combination therapy with a
peroxisome proliferator-activated
receptor gamma (P