Vildagliptin/Metformin Rafarm 50mg/850mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

Rafarm S.A. 12, Korinthou Str., 15451 Neo Psihiko, Athens, Greece

ATC code:

A10BD08

INN (International Name):

METFORMIN HYDROCHLORIDE 850 mg VILDAGLIPTIN 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin Rafarm50/850mg 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 663mg of metformin).
Excipient with known effect: 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).
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 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
between ‘V’ and ‘B’ on one
side and with a scoreline on the other. 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 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR _
_≥ _
_90 ml/min) _