Vildagliptin/Metformin HCl AET Tablet, film coated 50mg/850mg

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

VILDAGLIPTIN; METFORMIN HYDROCHLORIDE

Saatavilla:

ALFRED E. TIEFEMBACHER (GmbH &Co. KG)

ATC-koodi:

A10BD08

INN (Kansainvälinen yleisnimi):

VILDAGLIPTIN; METFORMIN HYDROCHLORIDE

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

VILDAGLIPTIN 50 mg; METFORMIN HYDROCHLORIDE 850 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

DRUGS USED IN DIABETES

Valtuutuksen tilan:

Authorised

Pakkausseloste

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

Valmisteyhteenveto

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin HCl AET 50 mg/850 mg film-coated tablets
Vildagliptin/Metformin HCl AET 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
50
mg
of
vildagliptin
and
850
mg
of
metformin
hydrochloride (corresponding to 660 mg of metformin).
Each
film-coated
tablet
contains
50
mg
of
vildagliptin
and
1000
mg
of
metformin
hydrochloride (corresponding to 780 mg of metformin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, ovaloid film coated tablet with bevelled edge, plain surface
on both sides with
dimensions of approximately 20.7 X 8.8 mm.
Dark yellow, ovaloid film coated tablets with bevelled edge, plain
surface on both sides with
dimensions of approximately 21.3 X 10.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin/Metformin HCl AET is indicated in the treatment of type 2
diabetes mellitus:
-
Vildagliptin/Metformin HCl AET is indicated in the treatment of adult
patients who
are unable to achieve sufficient glycaemic control at their maximally
tolerated dose of
oral metformin alone or who are already treated with the combination
of vildagliptin
and metformin as separate tablets.
-
Vildagliptin/Metformin HCl AET is indicated in combination with a
sulphonylurea
(i.e. triple combination therapy) as an
adjunct to diet and exercise in adult patients
inadequately controlled with metformin and a sulphonylurea.
-
Vildagliptin/Metformin
HCl
AET
is
indicated
in
triple
combination therapy with
insulin as an adjunct to diet and exercise to improve glycaemic
control in adult patients
when insulin at a stable dose and metformin alone do not provide
adequate glycaemic
control.
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 Vildagliptin/Metformin HCl
AET should be
individualised on the basis o