Vildagliptin Adair 50 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VILDAGLIPTIN

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

A10BH02

INN (International Name):

VILDAGLIPTIN 50 mg

Pharmaceutical form:

TABLET

Composition:

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:

2021-07-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VILDAGLIPTIN ADAIR 50 MG TABLETS
Vildagliptin
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 Adair is and what it is used for
2.
What you need to know before you take Vildagliptin Adair
3.
How to take Vildagliptin Adair
4.
Possible side effects
5.
How to store Vildagliptin Adair
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN ADAIR IS AND WHAT IT IS USED FOR
The active substance of Vildagliptin Adair , vildagliptin, belongs to
a group of medicines called “oral
antidiabetics”.
Vildagliptin is used to reat adult patients with type 2 diabetes. It
is used when diabetes cannot be
controlled by diet and exercise alone. It helps to control the level
of sugar in the blood. Your doctor
will prescribe Vildagliptin Adair either alone or together with
certain other antidiabetic medicines
which you will already be taking, if these have not proved
sufficiently effective to control diabetes.
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.
Insulin is a substance which helps to lower the level of sugar in the
blood, especially after meals.
Glucagon is a substance with triggers the production of sugar by the
liver, causing the blood sugar
level to rise. The pancreas makes both of these substances.
HOW VILDAGLIPTIN ADAIR WORKS
Vildagliptin Adair works by making the pan

Summary of Product characteristics

1
_1. _
_NAME OF THE MEDICINAL PRODUCT _
Vildagliptin Adair 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect:
Each tablet contains 119.59 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white round biconvex tablets of approximately 8.0 mm
diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus
in adults:
As monotherapy
•
in patients inadequately controlled by diet and exercise alone and for
whom metformin
is inappropriate due to contraindications or intolerance.
As dual oral therapy in combination with
•
Metformin, in patients with insufficient glycaemic control despite
maximal tolerated
dose of monotherapy with metformin,
•
A sulphonylurea, in patients with insufficient glycaemic control
despite maximal
tolerated dose of a sulphonylurea and for whom metformin is
inappropriate due to
contraindications or intolerance,
•
A thiazolidinedione, in patients with insufficient glycaemic control
and for whom the
use of a thiazolidinendione is appropriate.
2
As triple oral therapy in combination with
•
A sulphonylurea and metformin when diet and exercise plus dual therapy
with these
medicinal products do not provide adequately glycaemic control.
Vildagliptin is also indicated for use in combination with insulin
(with or without metformin)
when diet and exercise plus a stable dose of insulin do not provide
adequate glycaemic
control.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
When used as monotherapy, in combination with metformin, in
combination with
thiazolidinedione, in combination with metformin and sulphonylurea, or
in combination with
insulin (with or without metformin), the recommended daily dose of
vildagliptin is 100mg,
administered as one dose of 50mg in the morning and one dose of 50mg
in the evening.
When used in dual combination with a sulphonylurea, the recommended
dos