Vildagliptin/Metformin HCl Merck 50mg/1000mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Tilgængelig fra:

Merck Healthcare KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany

ATC-kode:

A10BD08

INN (International Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Recept type:

POM

Terapeutisk område:

DRUGS USED IN DIABETES

Autorisation status:

Withdrawn

Autorisation dato:

2018-02-16

Indlægsseddel

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN/METFORMIN HCL MERCK 50 MG/850 MG FILM-COATED TABLETS
VILDAGLIPTIN/METFORMIN HCL MERCK 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 Merck is and what it is used for
2.
What you need to know before you take Vildagliptin/Metformin HCl Merck
3.
How to take Vildagliptin/Metformin HCl Merck
4.
Possible side effects
5.
How to store Vildagliptin/Metformin HCl Merck
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN/METFORMIN HCL MERCK IS AND WHAT IT IS USED FOR
The active substances of Vildagliptin/Metformin HCl Merck,
vildagliptin and metformin, belong to a
group of medicines called “oral antidiabetics”.
Vildagliptin/Metformin HCl Merck 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 MERCK WORKS
Both active substances, vildagliptin and metformin, help to control
the level of sugar in the b

Produktets egenskaber

Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin HCl Merck 50 mg/850 mg film-coated tablets
Vildagliptin/Metformin HCl Merck 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 Merck is indicated in the treatment of type
2 diabetes mellitus:
-
Vildagliptin/Metformin HCl Merck 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 Merck 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 Merck 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.
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
Merck
should
be
individualised on the basis o