Vildagliptin/Metformin Galenicum 50 mg/ 850 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):

METFORMIN HYDROCHLORIDE 850 mg VILDAGLIPTIN 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

METFORMIN HYDROCHLORIDE 850 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:

2021-01-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN/METFORMIN GALENICUM 50 MG/850 MG FILM-COATED TABLETS
VILDAGLIPTIN/METFORMIN GALENICUM 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 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 noninsulin- 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 VILDAGLIPTIN/METFORMIN WORKS
Both a

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildaglptin/Metformin Galenicum 50/850mg and 50/1000mg film coated
tablets
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 663 mg of metformin).
Excipient with known effect: Each tablet contains 93.5 mg of lactose
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).
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 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. Table length: 19.4

0.5 mm
The score line is not intended for breaking the tablet.
Vildagliptin/Metformin 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. Table 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 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
_Adults with normal renal function (GFR _
_≥ _
_90 ml/mi