Melkart Duo 50mg/850mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

ATC code:

A10BD08

INN (International Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-01-11

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Melkart Duo50/850mg and 50/1000mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin/Metformin 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).
Each tablet contains 93.5 mg of lactose
Vildagliptin/Metformin 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).
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 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. Table length: 19.4
±
0.5 mm
The score line is not intended for breaking the tablet.
Vildagliptin/Metformin 50 mg/1000 mg film-coated tablets
Dark yellow, oblong oval-shaped film-coated tablets with a scoreline
in both sides, and with “V” on
one side and “B” on the other side. Table 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 is indicated in the treatment of type 2
diabetes mellitus:
- Vildagliptin/Metformin 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 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 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