MUCOSOLVAN LIQUID 30MG5ML

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:

100 ml

Manufactured by:

Delpharm Reims

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
_ _
MUCOSOLVAN
®
LIQUID 30MG/5ML
Ambroxol hydrochloride (30mg/5ml)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What MUCOSOLVAN LIQUID
30MG/5ML is used for
2.
How MUCOSOLVAN LIQUID
30MG/5ML works
3.
Before you use MUCOSOLVAN
LIQUID 30MG/5ML
4.
How to use MUCOSOLVAN
LIQUID 30MG/5ML
5.
While you are using
MUCOSOLVAN LIQUID
30MG/5ML
6.
Side effects
7.
Storage and Disposal of
MUCOSOLVAN
LIQUID
30MG/5ML
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MUCOSOLVAN LIQUID
30MG/5ML IS USED FOR
MUCOSOLVAN LIQUID 30MG/5ML
is used to thin the mucus in acute and
chronic bronchial and lung diseases
where thick and tenacious mucus is a
problem.
HOW MUCOSOLVAN LIQUID
30MG/5ML 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.
MUCOSOLVAN LIQUID 30MG/5ML
works in two ways, firstly by relieving
irritation in the throat (the milk and
honey effect) and secondly by thinning
sticky, tenacious mucus in the bronchial
passages.
BEFORE YOU USE MUCOSOLVAN
LIQUID 30MG/5ML
-
_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.
Mucosolvan Liquid contains sorbitol.
If you have rare hereditary fructose
intolerance, 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 or liver
problems, check with your doctor
before taking this medicine.
•
PREGNANCY
The use of Mucosolvan in the first
trimester is not r

Summary of Product characteristics

COMPOSITION
5 ml of the solution contains
30 mg ambroxol hydrochloride
Excipients with known effect:
This medicine contains 2.5 mg
benzoic acid and 28.75 mg
propylene glycol (ingredient of
the flavours) in 5 ml of solution.
List of excipients
Benzoic acid, hydroxyethylcellulose,
sucralose, flavouring agents
(containing propylene glycol),
purified water.
DESCRIPTION
Oral solution
Colourless liquid with a fruity odour.
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 hydrochloride in vitro.
In clinical studies in patients with
sore throat, pharyngeal pain and
redness was significantly reduced.
Following