Vildagliptin/Metformin GAP 50 mg/1000 mg film-coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Disponível em:

GAP S.A 46, Agissilaou Street, 17341 Agios Dimitrios, Athens, Greece

Código ATC:

A10BD08

DCI (Denominação Comum Internacional):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Tipo de prescrição:

POM

Área terapêutica:

DRUGS USED IN DIABETES

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Authorised

Data de autorização:

2022-07-20

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN/METFORMIN GAP 50 MG/850 MG FILM-COATED TABLETS
VILDAGLIPTIN/METFORMIN GAP 50 MG/1000 MG FILM-COATED TABLETS
vildagliptin/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 Vildagliptin/Metformin GAP is and what it is used for
2.
What you need to know before you take Vildagliptin/Metformin GAP
3.
How to take Vildagliptin/Metformin GAP
4.
Possible side effects
5.
How to store Vildagliptin/Metformin GAP
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN/METFORMIN GAP IS AND WHAT IT IS USED FOR
The active substances of Vildagliptin/Metformin GAP, vildagliptin and
metformin, belong to a group
of medicines called “oral antidiabetics”.
Vildagliptin/Metformin GAP is used to treat adult patients with type 2
diabetes. This type of diabetes
is also known as noninsulin- dependent diabetes mellitus.
Vildagliptin/Metformin GAP 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 VILDAGLIPTIN/ME

Características técnicas

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin GAP 50 mg/850 mg film-coated tablets
Vildagliptin/Metformin GAP 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin/Metformin GAP 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 663 mg of metformin).
Excipient with known effect: Each tablet contains 93.5 mg of lactose
Vildagliptin/Metformin GAP 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)
Excipient with known effect: Each tablet contains 110 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet.
Vildagliptin/Metformin GAP 50 mg/850 mg film-coated tablets
Yellow, oblong-oval-shaped film-coated tablets with a scoreline on one
side and “VA” on the other
side. Tablet length: 19.4

0.5 mm
The score line is not intended for breaking the tablet.
Vildagliptin/Metformin GAP 50 mg/1000 mg film-coated tablets
Dark yellow, oblong-oval shaped film-coated tablets with a scoreline
in between “V” and “B” on one
side, and with a scoreline on the other. Tablet length: 21.1

0.5 mm
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin/Metformin GAP is indicated in as an adjunct to diet and
exercise to improve glyceamic
control in
adults with type 2 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 ADMINISTR