Mucosolvan 24 Hours Capsule 75mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ambroxol hydrochloride

Available from:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

ATC code:

R05CB06

Dosage:

75mg

Pharmaceutical form:

CAPSULE, DELAYED RELEASE

Composition:

ambroxol hydrochloride 75mg

Administration route:

ORAL

Prescription type:

General Sale List

Manufactured by:

Sanofi Winthrop Industrie

Authorization status:

ACTIVE

Authorization date:

2007-11-15

Patient Information leaflet

ambroxol hydrochloride
75mg Prolonged-release hard capsule
PATIENT INFORMATION LEAFLET
(A) WHAT
MUCOSOLVAN ONCE-
DAILY PROLONGED-RELEASE
CAPSULES CONTAIN
The active substance is:
Ambroxol hydrochloride.
One prolonged-release hard
capsule contains 75 mg
ambroxol hydrochloride.
The other excipients are:
Capsule content:
Crospovidone
Carnauba wax
Stearyl alcohol
Magnesium stearate
Capsule shell:
Gelatin
Water, purified
Titanium dioxide E 171
Red iron oxide E172
Yellow iron oxide E 172
Printing ink:
Shellac
Isopropyl alcohol
n-Butyl alcohol
Propylene glycol
Titanium dioxide
(B) WHAT MUCOSOLVAN
ONCE-DAILY PROLONGED-
RELEASE CAPSULES ARE AND
WHAT THEY ARE USED FOR
Mucosolvan is used in
conditions where there are
a lot of thick secretion 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 ONCE-
DAILY PROLONGED-RELEASE
CAPSULES
MUCOSOLVAN ONCE-DAILY
PROLONGED-RELEASE CAPSULES
SHOULD NOT BE TAKEN:
•
If you are hypersensitive
(allergic) to the active
substance ambroxol
hydrochloride or to 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 mucosal
lesions in the mouth, throat,
nose, eyes and genital region),
stop taking MUCOSOLVAN
once-daily prolonged-release
capsules and seek medical
advice immediately.
_Patients with impaired kidney _
_or liver function _
If you suffer from impaired
kidney function or a severe
liver disease, MUCOSOLVAN
once-daily prolonged-release
capsules should only be used
on medical advice. As with
any medicine that is
metabolised by the liver and
then excreted via the kidneys,
an accumulation of the
metabolic products
(metabolites) of ambroxol
produced in the liver can be
expected in patients with
sev

Summary of Product characteristics

SG/MUC24/0321/ CCDS0110-06
Mucosolvan

24 Hours
ambroxol hydrochloride 75mg
sustained release capsule
PATIENT INFORMATION LEAFLET
(A)
ACTIVE INGREDIENTS
Each Mucosolvan 24 Hours
contains ambroxol hydrochloride
75mg.
(B)
INACTIVE INGREDIENTS
Mucosolvan 24 Hours also
contains crospovidone collidon
CL, carnauba wax, stearyl alcohol,
magnesium stearate.
(C)
WHAT MUCOSOLVAN IS USED FOR
Mucosolvan is used in conditions
where there are a lot of thick
secretion or mucus in your air
passages.
Mucosolvan contains ambroxol
hydrochloride, which helps to
clear the chest by thinning the
mucus in your air passage.
(D)
TAKING MUCOSOLVAN
The recommended dose for adults
is 1 capsule once daily.
The capsules should not be
opened or chewed, but swallowed
whole with ample liquid.
Mucosolvan can be taken with or
without food.
The use of Mucosolvan without
medical supervision is not
intended in patients who suffer
from such condition chronically.
Medical advice should be sought
if the symptoms last longer than
14 days and/or if the symptoms
increase in spite of treatment with
Mucosolvan.
(E)
WARNINGS

WHEN YOU MUST NOT TAKE
MUCOSOLVAN
Do not use Mucosolvan if you are
allergic to ambroxol 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.
In very few cases, severe skin
disorders such as Stevens-
Johnson's syndrome and toxic
epidermal necrolysis (TEN) have
been reported after administration
of expectorants (e.g. ambroxol
hydrochloride), which in most
cases could be explained by the
patient’s underlying disease
and/or the concomitant
medication. In addition during the
early phase of a Steven-Johnson
Syndrome or TEN a patient may
first experience non-specific
influenza-like prodromes (e.g.
fever, aching body, rhinitis, cough
and sore throat). Mislead by these
non-specific influenza-like
prodromes it is possible that a
symptomatic treatment is