Vildagliptine/Metformine hydrochloride Intas 50 mg/1000 mg filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 780 mg/stuk ; VILDAGLIPTINE 50 mg/stuk

INN (International Name):

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 780 mg/stuk ; VILDAGLIPTINE 50 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Administreringsrute:

Oraal gebruik

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTINE/METFORMINE HYDROCHLORIDE INTAS 50 MG/850 MG FILMOMHULDE
TABLETTEN
VILDAGLIPTINE/METFORMINE HYDROCHLORIDE INTAS 50 MG/1000 MG FILMOMHULDE
TABLETTEN
vildagliptine/metformine 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 vildagliptin/metformin is and what it is used for
2.
What you need to know before you take vildagliptin/metformin
3.
How to take vildagliptin/metformin
4.
Possible side effects
5.
How to store vildagliptin/metformin
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN/METFORMIN IS AND WHAT IT IS USED FOR
The active substances of vildagliptin/metformin, vildagliptin and
metformin, belong to a group of
medicines called “oral antidiabetics”.
Vildagliptin/metformin is used to treat adult patients with type 2
diabetes. This type of diabetes is also
known as non- insulin-dependent diabetes mellitus.
Vildagliptin/metformin is used when diabetes cannot be controlled by
diet and exercise alone and/or
with other medicines used to treat diabetes (insulin or
sulphonylureas).
Type 2 diabetes develops if the body does not make enough insulin or
if the insulin that the body
makes does not work as well as it should. It can also develop if the
body produces too much glucagon.
Both insulin and glucagon are made in the pancreas. Insulin helps to
lower the level of sugar in the
blood, especially after meals. Glucagon triggers the liver to make
sugar, causing the blood sugar level
to rise.
HOW VILDAG

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptine/Metformine hydrochloride Intas 50 mg/850 mg filmomhulde
tabletten
Vildagliptine/Metformine hydrochloride Intas 50 mg/1000 mg filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
vildagliptin/metformin 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 660 mg of metformin).
vildagliptin/metformin 50 mg/1000 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of
metformin hydrochloride
(corresponding to 780 mg of metformin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
vildagliptin/metformin 50 mg/850 mg film-coated tablets
Yellow coloured, oval shaped, biconvex, film-coated tablet, debossed
with “GG2 on one side and
plain on the other side. The dimensions of the tablet are
approximately 20,15 x 8,00 mm.
vildagliptin/metformin 50 mg/1000 mg film-coated tablets
Dark yellow coloured, oval shaped, biconvex, film-coated tablet,
debossed with “GG3” on one side
and plain on the other side. The dimensions of the tablet are
approximately 21,11 x 8,38 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
vildagliptin/metformin is indicated as an adjunct to diet and exercise
to improve glycaemic control in
adults with type2 diabetes mellitus::
-
In patients who are inadequately controlled with metformin
hydrochloride alone.
-
In patients who are already being treated with the combination of
vildagliptin and metformin
hydrochloride, as separate tablets.
-
In combination with other medicinal products for the treatment of
diabetes, including insulin,
when these do not provide adequate glycaemic control (see sections
4.4, 4.5 and 5.1 for
available data on different combinations..
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR ≥ 90 ml/min) _
The dose of antihyperglycaemic therapy with vildagliptin/metformin
should be individualised on the