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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

A10BD08

INN (International Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-12-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN/METFORMIN ADAIR 50 MG/850 MG FILM-COATED TABLETS
VILDAGLIPTIN/METFORMIN ADAIR 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 Adair is and what it is used for
2.
What you need to know before you take Vildagliptin/Metformin Adair
3.
How to take Vildagliptin/Metformin Adair
4.
Possible side effects
5.
How to store Vildagliptin/Metformin Adair
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN/METFORMIN ADAIR IS AND WHAT IT IS USED FOR
The active substances of Vildagliptin/Metformin Adair, vildagliptin
and metformin, belong to a group
of medicines called “oral antidiabetics”.
Vildagliptin/Metformin Adair is used to treat adult patients with type
2 diabetes. This type of diabetes
is also known as noninsulin- dependent diabetes mellitus. It is used
when diabetes cannot be controlled
by diet and exercise alone. It helps to control the level of sugar in
the blood. Your doctor will
prescribe Vildagliptin/Metformin either alone or together with certain
other antidiabetic medicines
which you will already be taking, if these have not proved
sufficiently effective to control diabetes.
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 pan

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin Adair 50 mg/850 mg and 50 mg/1000 mg film
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin/Metformin Adair 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 662.88 mg of metformin).
Excipient with known effect: Each tablet contains 93.5 mg of lactose
Vildagliptin/Metformin Adair 50 mg/1000 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of
metformin hydrochloride
(corresponding to 779.86 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 Adair 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 Adair 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 Adair is indicated 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2
_Adults with nor