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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

Kern Pharma, S.L. Polígono Industrial Colón II Calle Venus 72 08228, Terrassa, Barcelona , Spain

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:

Authorised

Authorization date:

2021-01-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN/METFORMIN KERN PHARMA 50 MG/850 MG FILM-COATED TABLETS
VILDAGLIPTIN/METFORMIN KERN 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 Kern Pharma is and what it is used for
2.
What you need to know before you take Vildagliptin/Metformin Kern
Pharma
3.
How to take Vildagliptin/Metformin Kern Pharma
4.
Possible side effects
5.
How to store Vildagliptin/Metformin Kern Pharma
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN/METFORMIN KERN PHARMA 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 non-insulin-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 bl

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin/Metformin Kern Pharma 50/850mg and 50/1,000mg 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 Kern Pharma 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. Tablet length: 19.4

0.5 mm
The score line is not intended for breaking the tablet.
Vildagliptin/Metformin Kern Pharma 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. 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 is indicated as an adjunct to diet and exercise
to improve glycaemic 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
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_Adults with normal renal function (GFR _
_≥ _
_90 ml/min) _
The dose of antihype