SW BROMHEXINE TABLET 8MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Bromhexine HCl

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

Bromhexine HCl

Unit dalam pakej:

100 x10 Tablets; 50 Tablets; 1000 Tablets; 10x10 Tablets; 50 x10 Tablets

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

SW BROMHEXINE TABLET
Bromhexine Hydrochloride (8mg)
1
_ Consumer Medication Information Leaflet (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SW Bromhexine Tablet is used for
2. How SW Bromhexine Tablet works
3. Before you use SW Bromhexine Tablet
4. How to SW Bromhexine Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of SW Bromhexine
Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SW BROMHEXINE TABLET IS USED FOR
It is indicated for nasal (inflammation of the
mucous
membrane
in
the
bronchial
tubes)
and
other
respiratory
condition
as
aid
to
support
the
body
clearing
the
muccus
expectoration.
HOW SW BROMHEXINE TABLET WORKS
The
active
ingredient
in
this
medicine
is
bromhexine
hydrochloride.
Bromhexine
hydrochloride is a synthetic derivative of the
herbal active ingredient vasicine. It enhance
mucus transport by reducing viscosity and by
activating
the
ciliated
epithelium
(mucociliary clearance). The ambroxol is a
metabolite of bromhexine, hence it is highly
bound to plasma protein
BEFORE YOU USE SW BROMHEXINE TABLET
_- When you must not use it _
Do
not
take
this
medicine
if
you
are
hypersensitive to bromhexine hydrocholoride
or any of the other ingredients listed at the
end of the leaflet.
_ _
_Pregnancy and breastfeeding _
You should check with your doctor if you are
or think you may be pregnant, planning to
become pregnant or if you are breastfeeding.
It is not recommended for pregnant women
and
nursing
mothers
unless
the
expected
benefit outweighs any potential risks.
_- Before you start to use it _
Tell your doctor before taking this medicine
if you have:

Peptic/Gastirc ulser
_- Taking other medicines _
There are a few medicines which may inter-
act
with
SW
Bromhexine
Tablet.
It
is
important to tell your doctor or pharmacist
about all the medicines that you are taking,
including those obtained without doctor’s
prescription. You should talk to your doctor or
pharmacist if you are taking:-

Erythromycin or Cephalexin antibiotic
HO

Ciri produk

PKG NO
Product Name
Revision Code
Colour
Dimension
_Regulatory Department_
_Artwork_
_ Information_
:
:
:
:
:
SW BROMHEXINE ELIXIR/ TABLET LEAFLET
CL305A-R12
BLACK LETTERING
72MM (W) X 108MM (H)
BROMHEXINE ELIXIR/TABLET
Bromhexine HCl
Preservative: Methyl Paraben
Bromhexine Elixir
4 mg / 5ml
10 mg / 5ml
Bromhexine Tablet
8 mg / Tablet
-
PHARMACOLOGY:
Bromhexine is a synthetic derivative of the herbal active ingredient
vasicine. Preclinically, it has
been shown to increase the proportion of serous bronchial secretion.
Bromhexine enhances
mucous
transport
by
reducing
mucous
viscosity
and
by
activating
the
ciliated
epithelium
(mucociliary clearance). In clinical studies, bromhexine showed a
secretolytic and secretomotor
effect in the bronchial tract area, which facilitates expectoration
and eases cough.
Bromhexine hydrochloride is rapidly absorbed from the
gastro-intestinal tract and about 85 to 90%
of a dose is excreted in the urine mainly as metabolites. Ambroxol is
a metabolite of bromhexine.
Bromhexine is highly bound to plasma proteins.
Administration
of
bromhexine
HCl
by
mouth
to
healthy
subjects
produced
peak
plasma
concentrations after about 1 hour. Only small amounts were excreted
unchanged in the urine with a
half-life of about 6.5 hours.
INDICATIONS:
It is indicated in bronchitis and other respiratory conditions as an
aid to expectoration.
CONTRAINDICATIONS:
It is contraindicated in patients who is hypersensitive to it and
should be given cautiously to
patients with gastric ulceration.
SIDE EFFECTS/ADVERSE REACTIONS:
Gastro-intestinal
side
effects
may
occur
occasionally
and
a
transient
rise
in
serum
amino-transferase values has been reported.
Immune System Disorders
Frequency not known: Anaphylactic reactions including anaphylactic
shock.
Skin and Subcutaneous Skin Disorders
Frequency
not
known:
Severe
skin
reactions
(including
Stevens
Johnson
syndrome,
Toxic
Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute
Generalized Exanthematous
Pustulosis (AGEP).
PRECAUTIONS/WARNINGS:
Bromhexine should