Vimetso 50 mg/850 mg film-coated tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Disponible desde:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Código ATC:

A10BD08

Designación común internacional (DCI):

METFORMIN HYDROCHLORIDE 850 mg VILDAGLIPTIN 50 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

METFORMIN HYDROCHLORIDE 850 mg VILDAGLIPTIN 50 mg

tipo de receta:

POM

Área terapéutica:

DRUGS USED IN DIABETES

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Authorised

Fecha de autorización:

2021-07-14

Información para el usuario

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIMETSO 50 MG/850 MG FILM-COATED TABLETS
VIMETSO 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 or pharmacist.
-
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vimetso is and what it is used for
2.
What you need to know before you take Vimetso
3.
How to take Vimetso
4.
Possible side effects
5.
How to store Vimetso
6.
Contents of the pack and other information
1.
WHAT VIMETSO IS AND WHAT IT IS USED FOR
The active substances of Vimetso, vildagliptin and metformin, belong
to a group of
medicines called “oral antidiabetics”.
Vimetso is used to treat adult patients with type 2 diabetes. This
type of diabetes is also
known as noninsulin- dependent diabetes mellitus. Vimetso 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 VIMETSO WORKS
Both active substances, vildagliptin and metformin, help to control
the level of sugar in the
blood. The substance vildagliptin works by making the pancreas produce
more insulin and
less gluca

Ficha técnica

Page
1
of
21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vimetso 50 mg/850 mg film-coated tablets
Vimetso 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vimetso 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg vildagliptin and 850 mg
metformin hydrochloride.
Vimetso 50 mg/1000 mg film-coated tablets
Each film-coated tablet contains 50 mg vildagliptin and 1000 mg
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Vimetso 50 mg/850 mg film-coated tablets
Brownish yellow, oval, biconvex, film-coated tablets with mark V1 on
one side of the tablet.
Tablet dimensions: approximately 20 mm x 11 mm.
Vimetso 50 mg/1000 mg film-coated tablets
Brown-yellow, oval, biconvex, film-coated tablets with mark V2 on one
side of the tablet.
Tablet dimensions: approximately 21 mm x 11 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimetso is indicated as an adjunct to diet and exercise to improve
glycaemic 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).
Page
2
of
21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults with normal renal function (GFR ≥ 90 ml/min) _
The dose of antihyperglycaemic therapy with Vimetso should be
individualised on the basis
of the patient’s current regimen, effectiveness and tolerability
while not exceeding the
maximum recommended daily dose of 100 mg vildagliptin. Vimetso may be
initiated at either
the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one
tablet in the morning
and the