Vildaben Plus 50mg/1000mg film-coated tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Tillgänglig från:

Bennett Pharmaceuticals SA 16th km Athinon-Lamias Kifisia 14564,, Greece

ATC-kod:

A10BD08

INN (International namn):

METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

METFORMIN HYDROCHLORIDE 1000 mg VILDAGLIPTIN 50 mg

Receptbelagda typ:

POM

Terapiområde:

DRUGS USED IN DIABETES

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2022-01-12

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDABEN PLUS 50 MG/850 MG FILM-COATED TABLETS
VILDABEN PLUS 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 Vildaben plus is and what it is used for
2.
What you need to know before you take Vildaben plus
3.
How to take Vildaben plus
4.
Possible side effects
5.
How to store Vildaben plus
6.
Contents of the pack and other information
1.
WHAT VILDABEN PLUS IS AND WHAT IT IS USED FOR
The active substances of Vildaben plus, vildagliptin and metformin,
belong to a group of
medicines called “oral antidiabetics”.
Vildaben plus is used to treat adult patients with type 2 diabetes.
This type of diabetes is also
known as non-insulin-dependent diabetes mellitus. Vildaben plus 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 VILDABEN PLUS WORKS
Both active substances, vildagliptin and metformin, help to control
the level of sugar in the blood. The
substance

Produktens egenskaper

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1.
NAME OF THE MEDICINAL PRODUCT
Vildaben plus 50 mg/850 mg and 50 mg/1000 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildaben plus 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).
Excipient with known effect: Each tablet contains 93.5 mg of lactose
Vildaben plus 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.
Vildaben plus 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.
Vildaben plus 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
Vildaben plus 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
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_Adults with normal renal function (GFR ≥ 90 ml/min)_
The dose of antihyperglycaemic t