Bilaxten 2.5 mgml Oral Solution

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Bilastine

Disponível em:

A. MENARINI SINGAPORE PTE. LTD.

DCI (Denominação Comum Internacional):

Bilastine

Unidades em pacote:

120 ml

Fabricado por:

BERLIN-CHEMIE AG

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
BILAXTEN
_®_
2.5 MG/ML ORAL SOLUTION
Bilastine
1
WHAT IS IN THIS LEAFLET
1.
What Bilaxten used for
2.
How Bilaxten works
3.
Before you use Bilaxten
4.
How to use Bilaxten
5.
While you are using Bilaxten
6.
Side effects
7.
Storage
and
Disposal
of
Bilaxten
8.
Product Description
9.
Manufacturer
and
Product
Registration holder
10.
Date of revision
WHAT BILAXTEN IS USED FOR
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. It may also be used
to treat itchy skin rashes (hives or
urticaria).
HOW BILAXTEN WORKS
Bilaxten contains the active substance
bilastine which is an antihistamine.
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 use it _
If your child is allergic to bilastine or
any of the other ingredients of this
medicine.
_- Before you start to use it _
Do not give this medicine to children
under 6
years of age
with a body
weight
below
20
kg
since
no
sufficient data are available.
Talk
to
your
doctor
or
pharmacist
before using Bilaxten if your child
has
moderate
or
severe
renal
or
hepatic impairment or if your child is
taking other medicines.
_- Taking other medicines _
Tell your doctor or pharmacist if your
child is taking, has recently taken or
might
take
any
other
medicines,
including medicines obtained without
a
prescription.
Some
medicines
should
not
be
taken
together
and
others
may
need
their
doses
to
be
altered when taken together.
Always
inform
your
doctor
or
pharmacist if your child is using or
receiving
any
of
the
following
medicines in addition to Bilaxten.
•
Ketoconazole
(an
antifungal
medicine)
•
Erythromycin (an antibiotic)
•
Diltiazem (to treat angina)
•
Cyclosp

Características técnicas

PACKAGE INSERT
BILAXTEN
2.5 MG/ML ORAL SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Bilaxten 2.5 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 2.5 mg of bilastine.
Excipients
with
known
effect:
methyl
parahydroxybenzoate
(E218)
(1.0
mg/ml),
propyl
parahydroxybenzoate (E216) (0.2 mg/ml)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution.
Clear, colourless, slightly viscous aqueous solution of pH 3.0-4.0,
without precipitate
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and
perennial) and urticaria.
Bilaxten 2.5 mg/ml Oral Solution is indicated in children aged 6 to 11
years with a body weight of
at least 20 kg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
Children 6 to 11 years of age with a body weight of at least 20 kg
10 mg bilastine (4 ml of oral solution) once daily for the relief of
symptoms of allergic rhino-
conjunctivitis (seasonal allergic rhinitis and perennial allergic
rhinitis) and urticaria.
The oral solution should be taken one hour before or two hours after
intake of food or fruit juice
(see section 4.5).
Children under 6 years of age and under 20 kg
Currently available data are described in section 4.4, 4.8, 5.1 and
5.2 but no recommendation on a
posology can be made. Therefore bilastine should not be used in this
age group.
_Adults: _
In adults and adolescents (over 12 years of age) the administration of
bilastine 20 mg tablets is
appropriate.
Duration of treatment:
For allergic rhino-conjunctivitis the treatment should be limited to
the period of exposure to
allergens. For seasonal allergic rhinitis treatment could be
discontinued after the symptoms have
resolved and reinitiated upon their reappearance. In perennial
allergic rhinitis continued treatment
may be proposed to the patients during the allergen exposure periods.
For urticaria the duration of
treatment depends on the type, duration and course of the com