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

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Pieejams no:

Auxilto Healthcare s.r.o. Bucharova 2657/12, Stodulky 158 00 Praha 5 , Czech Republic

ATĶ kods:

A10BD08

SNN (starptautisko nepatentēto nosaukumu):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Receptes veids:

POM

Ārstniecības joma:

DRUGS USED IN DIABETES

Produktu pārskats:

Licence number in the source country: NOT APPLICAPABLE

Autorizācija statuss:

Authorised

Autorizācija datums:

2022-07-15

Lietošanas instrukcija

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

Produkta apraksts

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