REXOM BROMHEXINE ELIXIR 4MG5ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Bromhexine HCl

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Bromhexine HCl

Unit dalam pakej:

60 ml; 60 ml; 90 ml; 90 ml; 100 ml; 100 ml; 120 ml; 120 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
REXOM
TM
BROMHEXINE ELIXIR
Bromhexine Hydrochloride (4mg/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What REXOM
TM
Bromhexine is
used for
2.
How REXOM
TM
Bromhexine works
3.
Before you use REXOM
TM
Bromhexine
4.
How to use REXOM
TM
Bromhexine
5.
While you are using REXOM
TM
Bromhexine
6.
Side effects
7.
Storage and disposal of REXOM
TM
Bromhexine
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REXOM
TM BROMHEXINE IS USED
FOR
It is used to loosen the mucus, making it
easier to cough up the mucus for airway
diseases,
accompanied
by
excessive
mucus and impaired mucus clearance.
HOW REXOM
TM BROMHEXINE WORKS
REXOM
TM
Bromhexine helps to clear
the chest by thinning the mucus in your
air passages.
BEFORE
YOU
USE
REXOM
TM
BROMHEXINE
_-When you must not use it _
It
should not be used if you had known to
be hypersensitive to Bromhexine or other
components of the formulation.
_-Before you start to use it _

There will be an expected increase in
the flow of secretions.

Should be used with care in people with
a history of ulcer in digestive tract and
asthma.
_Pregnancy and lactation_
Talk to you doctor before taking this
medicine
if
you
are
pregnant,
might
become pregnant or are breastfeeding.
Bromhexine should only be used if the
maternal condition justifies the potential
risk to the fetus or baby.
_-Taking other medicines _
Inform your doctor or pharmacist before
taking this medicines, including any that
you get without a prescription from your
pharmacy, supermarket or health food
shop.
Some
medicines
and
REXOM
TM
Bromhexine
may
interfere
with
each
other.
They
may
be
affected
by
REXOM
TM
Bromhexine or may affect
how well it works.

It may increase the concentration of
concurrently used antibiotics.
HOW TO USE REXOM
TM BROMHEXINE
_-How much to use _
Always
use
REXOM
TM
Bromhexine
exactly as your doctor has prescribed.
You should check with your doctor or
pharmacist if in doubt.
The usual dose:
Under 2 years: 1.25 ml
2 to

Ciri produk

REXOM
TM BROMHEXINE ELIXIR 4MG/5ML
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each 5ml contains:
Bromhexine HCl BP ...................................... 4 mg
Preservative:
Sodium Benzoate ........................................ 0.2% w/v
PRODUCT DESCRIPTION
Colourless liquid with strawberry flavour.
PHARMACODYNAMICS
Bromhexine
is an
expectorant/mucolytic agent. Following oral
administration,
Bromhexine
has
increased sputum volume and reduced the viscosity of bronchial
secretions in chronic bronchitis
patients.
PHARMACOKINETICS
Bromhexine HCl is rapidly absorbed from the gastrointestinal tract and
undergoes extensive first-pass
metabolism in the liver. It is widely distributed to body tissues.
About 85 to 90% of a dose is excreted
in
the
urine
mainly
as
metabolites.
Ambroxol
is
a
metabolite
of
bromhexine.
Peak
plasma
concentrations occur after about 1 hour following oral administration.
INDICATIONS
Secretolytic therapy in acute and chronic bronchopulmonary diseases
associated with abnormal
mucus secretion and impaired mucus transport.
RECOMMENDED DOSE
Under 2 years: 1.25 ml, 3 times a day
2 to 6 years: 2.5 ml, 3 times a day
6 to 12 years: 5 ml, 3 times a day
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
Bromhexine Elixir 4mg/5ml should not be used in patients known to be
hypersensitive to Bromhexine
or other components of the formulation.
WARNING AND PRECAUTIONS
Patients being treated with Bromhexine should be notified of an
expected increase in the flow of
secretions. Bromhexine should be used with care in patients with a
history of peptic ulcer disease.
Care is also advisable in asthmatic patients.
Very rare cases of chronically associated severe skin impairments such
as Stevens Johnson Syndrome,
Toxic
Epidermal
Necrolysis
(TEN),
Erythema
Multiforme
(EM)
and
Acute
Generalized
ExanthematousPustulosis (AGEP) have been reported. In most cases,
these could be explained by the
severity of the underlying disease or concomitant administration of
another drug. In the early stages
of such severe skin reactions, initiall