BILAXTEN 20mg Tablets

Country: Malaysia

Language: English

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

Active ingredient:

Bilastine

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

Bilastine

Units in package:

30tablet Tablets; 20tablet Tablets; 10tablet Tablets; 4tablet Tablets; 40tablet Tablets; 50tablet Tablets

Manufactured by:

A. Menarini Manufacturing Logistics and Services S.r.l.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BILAXTEN® 20MG TABLETS
Bilastine 20mg
Page 1
WHAT IS IN THIS LEAFLET
•
What is BILAXTEN® is used
for
•
How BILAXTEN® works
•
Before you use BILAXTEN®
•
How to take BILAXTEN®
•
While
you
are
using
BILAXTEN®
•
Side effects
•
Storage
and
Disposal
of
BILAXTEN®
•
Product description
•
Manufacturer
and
Product
Registration Holder
•
Date of Revision
WHAT BILAXTEN® IS USED FOR
BILAXTEN®
contains
bilastine
which
is
an
antihistamine.
BILAXTEN® is used to relieve the
symptoms
of
hayfever
(sneezing,
itchy,
runny,
blocked-up
nose
and
red
and watery
eyes) and
other
forms of allergic rhinitis. They may
also
be
used
to
treat
itchy
skin
rashes (hives or urticaria).
HOW BILAXTEN® WORKS
Bilastine
is
a
non-drowsy, long-
acting
antihistamine
that
helps
to
relieve symptoms of allergy such as
sneezing,
tearing
and
itching.
It
blocks
the
effects
of
histamine,
a
chemical substance produced by the
body
in
response
to
foreign
substances which the body is
allergic
to.
BEFORE YOU USE BILAXTEN®
_When you must not take it_
_ _
Do not take it if you are allergic
(hypersensitive) to bilastine or any
of
the
other
ingredients
of
BILAXTEN®
(see
Product
description).
Do not give this medicine to children
under 12 years of age. Ask your
doctor or pharmacist for appropriate
dosages in children under 12 years”.
Other
forms
of
this
medicine
–
bilastine 10 mg orodispersible tablets
or bilastine 2.5 mg/mL oral solution
may be more suitable for children 6
to 11 years of age with a body weight
of at least 20 kg - ask your doctor or
pharmacist.
Do
not
give
Bilastine
to
children
under 6 years of age with a body
weight
below
20
kg
since
no
sufficient data are available.
_BEFORE YOU START TO TAKE IT_
_ _
Inform
your
doctor
if
you
have
moderate or severe renal impairment
and you are taking other medicines
(see “Taking other medicines”).
Driving and using machines
It
has
been
demonstrated
that
bilastine 20 mg does not affect the
driving
performance
in
adults.
However
the
re

Summary of Product characteristics

BILAXTEN® 20 mg tablets
Bilastine
NAME OF THE MEDICINAL PRODUCT
BILAXTEN 20 mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of Bilastine.
PHARMACEUTICAL FORM
Oval biconvex scored white tablets (length 10 mm, width 5 mm) . The score line is only to facilitate breaking for
ease of swallowing and not to divide into equal doses.
CLINICAL PARTICULARS
Therapeutic indications
Symptomatic treatment of allergic rhino -conjunctivitis (seasonal and perennial) and urticaria. BILAXTEN 20mg
Tablet is indicated in adults and adolescents (12 years of age and over).
Posology and method of administration
Posology
Adults and adolescents (12 years of age and over)
20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (SAR and PAR) and
urticaria.
The tablet should be taken one hour before or two hours after intake of food or fruit juice (see interaction with other
medicinal products and other form s of interaction)
Special populations
Older people
No dosage adjustments are required in older patients (see section s Pharmacodynamic and Pharmacokinetic
properties). There is little experience in patients above the age of 65.
Patients with r enal impairment
No dosage adjustment is required in patients with renal impairment. (See section Pharmacokinetic properties).
Patients with h epatic impairment
There is no clinical experience in patients with hepatic impairment. Since bilastine is not meta bolized and renal
clearance is its major elimination route, hepatic impairment is not expected to increase systemic exposure above the
safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment (see section
Pharmacokinet ic properties).
Paediatric population
There is no relevant use of bilastine in children aged 0 to 2 years in the indications allergic rhino -conjunctivitis and
urticaria. The safety and efficacy in children below 12 years have not yet been established.
Duration of treatment:
For allergic rhinitis the treatment should be lim