BISCOMIN TABLETS 8MG

Country: Malaysia

Language: English

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

Active ingredient:

Bromhexine HCl

Available from:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Bromhexine HCl

Units in package:

1000 Tablets

Manufactured by:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
BISCOMIN TABLETS 8MG
Bromhexine HCl 8mg
WHAT IS IN THIS LEAFLET
1.
What Biscomin Tablets 8mg is
used for
2.
How
Biscomin
Tablets
8mg
works
3.
Before you use Biscomin Tablets
8mg
4.
How
to
use
Biscomin
Tablets
8mg
5.
While
you
are
using
Biscomin
Tablets 8mg
6.
Side effects
7.
Storage
and
Disposal
of
Biscomin Tablets 8mg
8.
Product description
9.
Manufacturer
and
Product
Registration holder
10.
Date of Revision
WHAT BISCOMIN TABLETS 8MG IS USED
FOR
Bromhexine
HCl
is
the
active
ingredient of Biscomin Tablets 8mg.
It is a mucolytic agent and is indicated
in
the
treatment
of
respiratory
disorders
associated
with
viscid
or
excessive mucus.
HOW BISCOMIN TABLETS 8MG WORKS
Bromhexine
alters
the
structure
of
mucus to decrease its viscocity and
therefore
facilitate
its
removal
by
ciliary action or expectoration.
BEFORE
YOU
USE
BISCOMIN
TABLETS
8MG
_- When you must not use it _

If
you
have
known
hypersensitivity to Bromhexine
or any of its ingredients
_ _
_- Before you start to use it _
You must tell your doctor if:

You
have
allergies
to
any
medicine which you have taken
previously to treat your current
condition.
_- Taking other medicines _
Always
inform
your
doctor
and
pharmacist if you are taking any other
medicines,
including
herbal
tonics,
supplements and medicines that you
buy without prescription.
HOW TO USE BISCOMIN TABLETS 8MG
Always take this medicine exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
_ _
_- How much to use _
ADULTS:
8-16mg
(1-2
tablets)
three
times a day
CHILDREN 6-12 YEARS OLD: 4mg (half
tablet) three times a day
_ _
_- When to use it _
Use
as
directed
by
your
doctor
or
pharmacist.
_ _
_- How long to use it _
Continue
taking
Biscomin
Tablets
8mg
for
as
long
as
your
doctor
recommends._ _
_ _
_- If you forget to use it _

If you forget a dose, take it as soon
as you remember it.

However, if it is nearly time for the
next dose, skip the missed dose.

Do not take a double dose

Summary of Product characteristics

7029-05
BISCOMIN TABLETS 8MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Each tablet contains:
Bromhexine Hydrochloride
…………………………………………………8mg
PRODUCT DESCRIPTION:
An orange, scored, flat of diameter 7mm round tablet with ‘MPI’
logo.
PHARMACODYNAMICS
:
Bromhexine is an expectorant/mucolytic agent. The drug is a
benzylamine derivative (2-amino-3,5-dibromo-N-cyclohexyl N-
methylbenzylamine hydrochloride) and also a derivative of vasicine and
adhatodic acid, alkaloids obtained from the plant
Adhatoda vasica.
Following oral administration, bromhexine has increase sputum volume
and reduced the viscosity of bronchial secretions in
chronic bronchitis patients. The drug has been reported to induce
hydrolytic depolymerization of mucoprotein fibers and stimulate
activity of the ciliated epithelium. An increase in lysosomal activity
facilitated by bromhexine has been postulated. Improvements
in pulmonary function in bronchitis patients appear secondary to
easier expectoration.
An effect
of
bromhexine on increasing sputum concentrations of
various antibiotics (e.g., oxytetracycline, erythromycin,
ampicillin, amoxicillin) has also been reported. However, some of
these effects (exocrine stimulation, increased sputum
concentrations) have not been confirmed in some studies.
It has been suggested that a metabolite of bromhexine, ambroxol, may
contribute to enhanced secretion from exocrine glands
during bromhexine administration.
PHARMACOKINETICS:
ABSORPTION
Oral, well absorbed. Rapidly absorbed from the gastrointestinal tract.
Peak plasma concentrations occur after about 1 hour
following oral administration.
DISTRIBUTION
It is widely distributed to body tissues. Bromhexine is highly bound
to plasma proteins. Bromhexine crosses blood-brain barrier
and small amounts cross the placenta.
METABOLISM
Bromhexine undergoes extensive first-pass metabolism in the liver.
Ambroxol is a metabolite of bromhexine.
EXCRETION
Bromhexine is excreted primarily in the urine as metabolites. Only
small amounts appe