Mucosolvan Tablet 30 mg

Country: Malaysia

Language: English

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

Active ingredient:

Ambroxol Hydrochloride

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

Ambroxol Hydrochloride

Units in package:

50 Tablets; 50 Tablets

Manufactured by:

Delpharm Reims

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MUCOSOLVAN
®
TABLET 30MG
Ambroxol hydrochloride (30mg)
WHAT IS IN THIS LEAFLET
1.
What MUCOSOLVAN TABLET
30MG is used for
2.
How MUCOSOLVAN TABLET
30MG works
3.
Before you use MUCOSOLVAN
tablets 30mg
4.
How
to
use
MUCOSOLVAN
tablets 30mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
MUCOSOLVAN TABLET 30MG
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
MUCOSOLVAN
TABLET
30MG IS USED FOR
MUCOSOLVAN TABLET 30MG is
used to thin the mucus in acute and
chronic
bronchial
and
lung
diseases
where thick and tenacious mucus is a
problem.
HOW
MUCOSOLVAN
TABLET
30MG WORKS
Mucosolvan contains a medicine called
ambroxol
which
helps
to
make
the
mucus thinner, activates the cilia to get
rid
of
mucus
faster,
and
stimulates
release of a fluid (surfactant) to protect
the lungs.
BEFORE YOU USE
MUCOSOLVAN
TABLET 30MG
-
_When you must not use it _
_ _
Do not use Mucosolvan if you are
allergic to ambroxol hydrochloride or
to
any
of
the
other
ingredients
in
Mucosolvan.
If you are not sure if you have these
allergies,
you
should
raise
those
concerns
with
your
doctor
or
pharmacist.
You should not use Mucosolvan after
the EXPIRY DATE on the carton or
container.
Mucosolvan Tablet contains lactose.
If you have rare hereditary galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-galactose
malabsorption, you should not take
this medicine.
In
very
few
cases,
severe
skin
disorders
have
been
reported
after
administration
of
mucolytic
substances
(e.g.
ambroxol
hydrochloride). Therefore if new skin
or
mucosal
lesions
occur,
medical
advice should be sought immediately
and
treatment
with
ambroxol
hydrochloride
discontinued
as
a
precaution.
If
you
have
any
kidney
problems,
check with your doctor before taking
this medicine.
In some rare lung diseases which are
associated
with
excessive
accumulation
of
secretions
(e.g.
primary
ciliary
dyskinesia),
MUCOSOLVAN TABLET 30MG
should only be used under medical
supervision becaus

Summary of Product characteristics

COMPOSITION
1 tablet contains
..........................................................................................................................................30
mg
trans-4-[(2-amino-3,5-dibromo-benzyl)amino] cyclohexanol
hydrochloride( = ambroxol hydrochloride)
Excipients**:
Tablets : lactose monohydrate, maize starch dried, silicia colloidal
anhydrous, magnesium
stearate
DESCRIPTION
Round, white tablets, both faces flat, with bevelled edges; one face
is scored and impressed
with ‘67C’ above and below the score: the other face is blank.
PROPERTIES
Preclinically,
ambroxol
hydrochloride,
the
active
ingredient
of
MUCOSOLVAN,
has
been shown to increase respiratory tract secretion. It enhances
pulmonary surfactant
production and stimulates ciliary activity. These actions result in
improved mucus flow and
transport(mucociliary clearance). Improvement of mucociliary clearance
has been shown
in clinical pharmacologic studies. Enhancement of fluid secretion and
mucociliary clearance
facilitates expectoration and eases cough.
In patients suffering from COPD, long-term treatment (6 months) with
Mucosolvan®
(Mucosolvan® Retard Capsule 75 mg) resulted in a significant
reduction of exacerbations
that became evident after 2 months of treatment. Patients in the
Mucosolvan® treatment
group lost significantly fewer days through illness and had fewer days
when they needed
antibiotic therapy. Treatment with Mucosolvan® Retard also induced a
statistically significant
improvement of symptoms (difficulty of expectoration, cough, dyspnea,
auscultatory signs)
compared with placebo.
A local anaesthetic effect of ambroxol hydrochloride has been observed
in the rabbit eye
model which may be explained by the sodium channel blocking
properties. It was shown
in vitro that ambroxol hydrochloride blocks cloned neuronal sodium
channels; binding was
reversible and concentration-dependent.
Cytokine release from blood but also tissue-bound mononuclear and
polymorphonuclear
cells was found to be significantly reduced by ambroxol hyd