VILDACORD (Vildagliptin Tablets 50 mg)

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

VILDAGLIPTIN

Tilgængelig fra:

ACCORD HEALTHCARE SDN.BHD.

INN (International Name):

VILDAGLIPTIN

Enheder i pakken:

56 Tablets

Fremstillet af:

INTAS PHARMACEUTICALS LIMITED

Indlægsseddel

VILDACORD
Vildagliptin (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Vildacord is used for
2.
How Vildacord works
3.
Before you use Vildacord
4.
How to use Vildacord
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Vildacord
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT VILDACORD IS USED FOR
Each Vildacord tablet contains 50 mg of
the active substance vildagliptin.
Vildacord
is a
medicine used
to
treat
patients
with
type
2
diabetes
whose
condition cannot be controlled by diet
and exercise alone. It helps to control the
level
of
sugar
in
the
blood.
Such
medicines
are
known
as
oral
antidiabetics.
Type 2
diabetes
develops
if
the body
does not produce enough insulin or if the
insulin that your 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 that helps to lower
the
level
of
sugar
in
your
blood,
especially
after
meals.
Glucagon
is
a
substance that triggers the production of
sugar
by
the
liver,
causing
the
blood
sugar level to rise. The pancreas makes
both of these substances.
HOW VILDACORD WORKS
Vildacord works by making the pancreas
produce more insulin and less glucagon.
Vildacord
helps
to
control
the
blood
sugar level.
Your
doctor
will
prescribe
Vildacord
either alone or in combination with other
antidiabetics
depending
on
your
condition.
It
is
important
that
you
continue
to
follow
the
diet
and/or
exercise
recommended to you while you are on
treatment with Vildacord.
Ask
your
doctor
if
you
have
any
questions about why this medicine has
been prescribed for you.
BEFORE YOU USE VILDACORD_ _
Follow all instructions given to you by
your doctor or pharmacist carefully, even
if
they
differ
from
the
information
contained in this leaflet.
-
_When you must not use it_
-
If you are allergic (hypersensitive)
to vildagliptin or any of the other
ingredients of Vildacord.
_PREGNANT WOMEN _
Tell your doctor if you are p

Produktets egenskaber

PACKAGE INSERT
VILDACORD (VILDAGLIPTIN TABLETS 50 MG)
COMPOSITION AND PHARMACEUTICAL FORM
Each uncoated tablets contains Vildagliptin 50 mg
For a full list of excipients, see section EXCIPIENTS.
VILDACORD: White to off-white, round, flat, beveled edge uncoated
tablets, debossed with
“GF1” and plain on other side.
INDICATIONS
Vildacord is indicated in the treatment of type 2 diabetes mellitus:
_As monotherapy _
_As combination therapy, _
•
Initial combination with metformin when diabetes is not adequately
controlled by diet and
exercise alone.
•
In combination with other medicinal products for the treatment of
diabetes, including
insulin, when these do not provide adequate glycaemic control.
DOSAGE AND ADMINISTRATION
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 metformin), the recommended daily dose of
vildagliptin is 100 mg,
administered as one dose of 50 mg in the morning and one dose of 50 mg
in the evening.
When used in dual combination with a sulphonylurea, the recommended
dose of vildagliptin is
50 mg once daily administered in the morning. In this patient
population, vildagliptin 100 mg daily
was no more effective than vildagliptin 50 mg once daily.
When used in combination with a sulphonylurea, a lower dose of the
sulphonylurea may be
considered to reduce the risk of hypoglycaemia.
When used as initial combination therapy with metformin, the
recommended dose of Vildagliptin
is 50 mg once or twice daily.
Doses higher than 100 mg are not recommended.
If a dose of Vildacord is missed, it should be taken as soon as the
patient remembers. A double
dose should not be taken on the same day.
The safety and efficacy of vildagliptin as triple oral therapy in
combination with metformin and a
thiazolidinedione have not been established.
Vildacord can be administered with or without a meal.
PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment is required in pa