REXOM BROMHEXINE TABLET 8MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
25-05-2022
Ciri produk Ciri produk (SPC)
25-04-2022

Bahan aktif:

Bromhexine HCl

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Bromhexine HCl

Unit dalam pakej:

10 Tablets; 30 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
REXOM
BROMHEXINE TABLET 8MG
Bromhexine Hydrochloride (8mg)
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
Bromhexine
is
mucolytic
used
in
the
treatment
of
respiratory
disorders
associated
with
productive
cough.
Generally, it is used in the treatment
conditions
of
the
respiratory
tract
associated
with
retention
of
mucoid
secretions such as bronchitis and asthma
as an aid to expectoration.
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 have known
to be hypersensitive to Bromhexine or
other components of the formulation.
_-Before you start to use it _
Should be used with care in people with
gastric ulceration.
_Pregnancy and lactation_
Talk to you doctor before taking this
medicine
if
you
are
pregnant,
might
become pregnant or are breastfeeding.
_ _
_-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.
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:
Adult: 8 to 16mg
Children 6 to 12years: 4mg
_-When to use it _
To be used 3 times daily. Use as directed
by your doctor or pharmacist.
_-How long to use it _
Continue taking REXOM
TM
Bromhexine
as
your
doctor
recommended.
If
symptoms persist, consult your doctor.
_ _
_-If you forget to use it _
Consult your doctor or ph
                                
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Ciri produk

                                REXOM
TM
BROMHEXINE TABLET 8MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each tablet contains:
Bromhexine Hydrochloride BP …............... 8mg
PRODUCT DESCRIPTION
White colour, round with top-score tablet.
PHARMACODYNAMICS
Bromhexine is a mucolytic agent, derived from benzylamine, vasicine
and adhatodic acid, alkaloids obtained from the plant
_Adhatoda vasica_
. It acts by increasing sputum volume and reducing the bronchial
secretions in chronic bronchitis patients. It
has been reported to induce hydrolytic depolymerization of mucoprotein
fibers and to stimulate the activity of ciliated
epithelium. Improvements in pulmonary function among bronchitis
patients in addition to easier expectoration is one of many
significant effect of bromhexine. Most of the dose is excreted in the
urine mainly as metabolite, Ambroxol whilst only a small
amount is excreted in the faeces.
PHARMACOKINETICS
Bromhexine HCl is rapidly absorbed from the gastrointestinal tract;
peak plasma concentrations occur after about 1 hour. It
undergoes extensive first pass metabolism in the liver; its oral
bioavailability is stated to be only 20% and widely distributed to
body tissues. About 85 to 90% of dose is excreted in the urine mainly
as metabolitie, Ambroxol. In addition to that, Bromhexine
is highly bound to plasma proteins with terminal elimination half-life
of 13 to 40 hours. Bromhexine crosses the blood-brain
barrier and small amounts crosses the placenta. INDICATION
Bromhexine is mucolytic used in the treatment of respiratory disorders
associated with productive cough. Generally, it is used in the
treatment conditions of the respiratory tract associated with
retention of mucoid secretions such as bronchitis and asthma as
an aid to expectoration.
RECOMMENDED DOSAGE
Usual adult dose: 8 to 16 mg 3 times daily
Children 6 to 12 years: 4 mg, 3 times daily
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
Hypersensitivity to bromhexine or other components of the formulation.
WARNINGS AND PRECAUTIONS
Should be given cautiously to patients with a h
                                
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