MUCOSOLVAN LIQUID 30 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AMBROXOL HCl

Available from:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

ATC code:

R05CB06

Dosage:

30mg/5ml

Pharmaceutical form:

ELIXIR

Composition:

AMBROXOL HCl 30mg/5ml

Administration route:

ORAL

Prescription type:

General Sale List

Manufactured by:

Delpharm Reims

Authorization status:

ACTIVE

Authorization date:

1989-06-30

Patient Information leaflet

CCDS V1
201912
Mucosolvan

30mg/5ml Liquid
ambroxol hydrochloride
(a)
What Mucosolvan Liquid
30mg/5ml contains
The active substance is:
ambroxol hydrochloride
5ml of solution contains 30
mg ambroxol
hydrochloride.
The other ingredients are:
Benzoic acid,
hydroxyethylcellulose,
sucralose, strawberry cream
flavour and vanilla flavour
(including propylene
glycol), purified water.
(b) What Mucosolvan Liquid
30mg/5ml is and what it is
used for
Mucosolvan is used in
conditions where there are a
lot of thick secretions or
mucus in your air passages.
Mucosolvan contains
ambroxol hydrochloride,
which helps to clear the
chest by thinning the mucus
in your air passage.
(c)
What you need to know
before you take
Mucosolvan Liquid
30mg/5ml
Do not take Mucosolvan
Liquid 30mg/5ml:

if you are allergic to the
active substance,
ambroxol hydrochloride,
or any of the other
ingredients of this
medicine (listed in
section a).
Warnings and
precautions
Talk to your doctor or
pharmacist before taking
this medicine.
There have been reports of
severe skin reactions
associated with the
administration of ambroxol
hydrochloride. If you
develop a skin rash
(including lesions of the
mucous membranes such as
mouth, throat, nose, eyes,
genitals), stop using
Mucosolvan Liquid
30mg/5ml and contact your
doctor immediately.
Patients with impaired
kidney or liver function
If you have impaired
kidney function or severe
liver disease, you must not
take Mucosolvan Liquid
30mg/5ml except on
medical advice. With
ambroxol, as with any
medicine which is broken
down in the liver and then
eliminated via the kidneys,
accumulation of the
breakdown products
(metabolites) of ambroxol
which are formed in the
liver can be expected to
occur in patients with
severely impaired kidney
function.
In some rare bronchial
diseases which are
associated with excessive
accumulation of secretions
(such as primary ciliary
dyskinesia), Mucosolvan
Liquid 30mg/5ml should
only be used under medical
supervision because of the
risk that secretions may
accumulate.
Children
Mucosol

Summary of Product characteristics

MUCOSOLVAN

COMPOSITION
5 ml liquid contains
30 mg
trans-4-[(2-amino-3,5-dibromo-benzyl)amino] cyclohexanol
hydrochloride( = ambroxol hydorchloride)
Excipients**.
Liquid 30 mg: hydroxyethylcellulose, benzoic acid, sucralose,
strawberry cream aroma, vanilla flavour, water purified
DESCRIPTION
Clear to almost clear and colourless to almost colourless slightly
viscous liquid.
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.
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.
Following the administration of ambroxol antibiotic concentrations
(amoxicilline, cefuroxime, erythromycin) in bronchopulmonary
secretions and in the sputum are increased.
PHARMACOKINETICS
Absorption:
Absorption of all immediate release oral forms of ambroxol
hydrochloride is rapid and complete, with dose linearity in the
therapeutic
range. Maximum plasma levels are reached within 1 to 2.5 hours
following oral administration of the immediate –release
formulation and after a median of 6.5 hours of the slow release
formulation. The absolute bioavailablility after a 30 mg tablet was
found to be 79%. The slow release capsule showed a relative
availability of 95% (dose-normalized) in comparison to a daily