Vildagliptin Accord 50 mg Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

VILDAGLIPTIN

थमां उपलब्ध:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ए.टी.सी कोड:

A10BH02

INN (इंटरनेशनल नाम):

VILDAGLIPTIN 50 mg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

VILDAGLIPTIN 50 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

DRUGS USED IN DIABETES

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2020-05-14

सूचना पत्रक

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
VILDAGLIPTIN ACCORD 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vildagliptin Accord is and what it is used for
2.
What you need to know before you take Vildagliptin Accord
3.
How to take Vildagliptin Accord
4.
Possible side effects
5.
How to store Vildagliptin Accord
6.
Contents of the pack and other information
1.
WHAT VILDAGLIPTIN ACCORD IS AND WHAT IT IS USED FOR
The active substance of Vildagliptin Accord, vildagliptin, belongs to
a group of medicines called “oral
antidiabetics”.
Vildagliptin Accord, is used to treat 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 Accord, 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 which triggers the production of sugar by the
liver, causing the blood sugar
level to rise. The pancreas makes both of these substances.
HOW VILDAGLIPTIN ACCORD WORKS
Vildagliptin Ac

उत्पाद विशेषताएं

Page
1
of
16
1.
NAME OF THE MEDICINAL PRODUCT
Vildagliptin Accord 50 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient(s) with known effect
Each tablet contains 45 mg lactose (anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round (8 mm diameter), flat, beveled edge uncoated
tablets debossed with “GF1” on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vildagliptin Accord 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
thiazolidinedione is appropriate.
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 adequate 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
a
sulphonylurea,
or
in
combination
with
insulin
(with
or
without
Page
2
of
16
metformin), the recommended daily dose of vildagliptin is 100 mg,
administered as one dose of 50 mg in the
morning and one dos