Xiliarx 50 mg Tablet

Riik: Malaisia

keel: inglise

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

Toimeaine:

VILDAGLIPTIN

Saadav alates:

DKSH MALAYSIA SDN BHD

INN (Rahvusvaheline Nimetus):

VILDAGLIPTIN

Ühikuid pakis:

7 Tablets; 28 Tablets; 56 Tablets

Valmistatud:

NOVARTIS FARMACEUTICA S.A.

Infovoldik

_Consumer Medication Information Leaflet (RiMUP) _
XILIARX
®
VILDAGLIPTIN 50 MG TABLETS
1
WHAT IS IN THIS LEAFLET
1.
WHAT XILIARX IS USED FOR
2.
HOW XILIARX WORKS
3.
BEFORE YOU TAKE XILIARX
4.
HOW TO USE XILIARX
5.
WHILE USING XILIARX
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
XILIARX
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT XILIARX IS USED FOR
Each Xiliarx tablet contains 50 mg
of the active substance
vildagliptin.
Xiliarx 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 XILIARX WORKS
Xiliarx works by making the
pancreas produce more insulin and
less glucagon. Xiliarx helps to
control the blood sugar level.
Your doctor will prescribe Xiliarx
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 Xiliarx.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
BEFORE YOU TAKE XILIARX
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 Xiliarx.
_PREGNANT WOMEN _
Tell your doctor if you are
pregnant, if you think you might
be pregna

Toote omadused

Novartis
Page 2
Malaysia Package Insert
13-Jul-2020
Xiliarx
XILIARX

COMPOSITION AND PHARMACEUTICAL FORM
Vildagliptin:
1-[(3-Hydroxy-adamant-1-ylamino)-acetyl]-pyrrolidine-2(S)-carbonitrile.
One oral tablet of Xiliarx contains 50 mg of vildagliptin.
For a full list of excipients, see section EXCIPIENTS.
Xiliarx 50 mg: white to light yellowish, round flat-faced with
bevelled-edges, unscored tablet.
One side is debossed with "NVR", and the other side with "FB".
INDICATIONS
Xiliarx is indicated in the treatment of type 2 diabetes mellitus:
•
As monotherapy
•
As combination therapy
o
Initial combination with metformin when diabetes is not adequately
controlled by
diet and exercise alone
o
In combination with other medicinal products for the treatment of
diabetes,
including insulin, when these do not provide adequate glycaemic
control (see
section
WARNINGS
AND
PRECAUTIONS,
section
INTERACTIONS
and
section CLINICAL STUDIES for available data on different
combinations).
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 Xiliarx
is 50 mg once or twice daily.
Doses higher than 100 mg are not recommended.
If a dose of Xiliarx is missed, it should be taken as soon as the
patient remembers. A double
dose should not be taken on the same