Hosolvon Elixir 4 mg5 ml (Sugar Free)

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

Bromhexine HCl

Inapatikana kutoka:

HOVID BERHAD

INN (Jina la Kimataifa):

Bromhexine HCl

Vitengo katika mfuko:

120 ml; 60 ml; 60ml mL; 120ml mL

Viwandani na:

HOVID BERHAD

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Page 1 of 2
HOSOLVON ELIXIR 4 MG/ 5ML (SUGAR FREE)
BROMHEXINE HYDROCHLORIDE 4 MG/ 5 ML
WHAT IS IN THIS LEAFLET?
1.
What Hosolvon is used for
2.
How Hosolvon works
3.
Before you use Hosolvon
4.
How to use Hosolvon
5.
While you are using Hosolvon
6.
Side effects
7.
Storage and Disposal of Hosolvon
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT HOSOLVON IS USED FOR
Secretolytic
therapy
in
acute
and
chronic
bronchopulmonary
diseases
associated
with
abnormal
mucus
secretion and impaired mucus transport.
HOW HOSOLVON WORKS
This
medicine
contains
bromhexine
hydrochloride as the active ingredients.
Bromhexine
acts
as
an
expectorant/
mucolytic
agent.
It
increases
sputum
volume
and
reduces
the
viscosity
of
bronchial
secretions
in
chronic
bronchitis patients. Secondary to this
effect,
bromhexine
also
improves
pulmonary
function
in
bronchitis
patients.
Metabolite
of
bromhexine,
ambroxol
may
also
contribute
to
enhanced
secretion from exocrine glands
BEFORE YOU USE HOSOLVON
_- When you must not use it _
_ _
Do not take this medicine if:
•
you are allergic to bromhexine, or
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin
Do
not
take
this
medicine
after
the
expiry date printed on the pack or if the
packaging is damaged.
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
_ _
Tell your doctor/pharmacist if:
•
you
have
allergies
to
any
other
medicines,
foods,
dyes
or
preservatives
•
you have gastric ulcer
•
you have asthma
•
you have liver problem
•
you have kidney problems
•
you are taking antibiotics
•
you are breastfeeding
•
you
are
pregnant,
think
you
are
pregnant, or plan to get pregnant.
_- Taking o

Tabia za bidhaa

DESCRIPTION
Clear, colourless, aniseed and menthol flavoured liquid.
COMPOSITION
Bromhexine hydrochloride 4 mg / 5 mL.
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 increased 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 (eg,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.
•
METABOLISM
Bromhexine undergoes extensive first-pass metabolism in the
liver: Ambroxol is a metabolite of bromhexine.
•
DISTRIBUTION
It is widely distributed to body tissues.
Bromhexine is highly bound to plasma proteins.
Bromhexine crosses the blood-brain barrier and small amounts
cross the placenta.
•
EXCRETION
Bromhexine is excreted primarily in the urine as metabolites.
Only small amounts appear as unchanged drug.
About 85 to 90% of a dose is excreted in the urine mainly as
metabolites.
Approximately 70% of an oral dose of brom