Vildagliptin/Metformin Genericon Pharma 50 mg/1000 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Genericon Pharma Gesellschaft m.b.H Hafnerstrasse 211, 8054 Graz, Austria

ATC code:

A10BD08

INN (International Name):

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VILDAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2022-06-17

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin Genericon Pharma 50 mg/850 mg film-coated
tablets
Vildagliptin/Metformin Genericon Pharma 50 mg/1000 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin/Metformin Genericon Pharma 50 mg/850 mg film-coated
tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 663 mg of metformin).
Exipient with known effect: Each tablet contains 93.5 mg of lactose
Vildagliptin/Metformin Genericon Pharma 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)
Exipient 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 Genericon Pharma 50 mg/850 mg film-coated
tablets
Yellow, oval-shaped film-coated tablets with a scoreline on one side
and “VA” on the other side.
Tablet length: 19.4

0.5 mm
The score line is not intended for breaking the tablet.
Vildagliptin/Metformin Genericon Pharma 50 mg/1000 mg film-coated
tablets
Dark yellow, oval shaped film-coated tablets with a scoreline in both
sides, and with “V” on one side
and “B” on the other side. Tablet 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 Genericon Pharma 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 dat