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

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

A10BD08

INN (International Name):

METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 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:

2022-07-20

Patient Information leaflet

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

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin Diagonalis 50 mg/850 mg film-coated tablets
Vildagliptin/Metformin Diagonalis 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin/Metformin Diagonalis
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 Diagonalis
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 Diagonalis
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 Diagonalis
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 Diagonalis 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
diffe