SOLUWAX EAR DROPS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Docusate sodium

Boleh didapati daripada:

HOE PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

Docusate sodium

Unit dalam pakej:

10ml mL; 100ml mL

Dikeluarkan oleh:

HOE PHARMACEUTICALS SDN. BHD.

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SOLUWAX EAR DROPS
Docusate Sodium (0.5% w/v)
1
WHAT IS IN THIS LEAFLET?
1.
What
SOLUWAX
EAR
DROPS is used for?
2.
How
SOLUWAX
EAR
DROPS works?
3.
Before you use SOLUWAX
EAR DROPS
4.
How
to
use
SOLUWAX
EAR DROPS
5.
While
you
are
using
SOLUWAX EAR DROPS
6.
Side effects
7.
Storage
and
Disposal
of
SOLUWAX EAR DROPS
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
This leaflet answers some common
questions about
_ _
SOLUWAX EAR
DROPS. It does not contain all the
available information. It does not
take the place of talking to your
pharmacist or doctor.
All
medicines
have
risks
and
benefits.
Your
pharmacist
or
doctor
has
weighed
the
risks
of
you
taking
SOLUWAX
EAR
DROPS against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
PHARMACIST OR DOCTOR.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it
again.
WHAT SOLUWAX EAR DROPS
IS USED FOR?
SOLUWAX EAR DROPS is used
to
easily
disperse
and
remove
excessive amounts of hardened ear
wax.
HOW SOLUWAX EAR DROPS
WORKS?
SOLUWAX
EAR
DROPS
contains
the
active
ingredient
Docusate Sodium 0.5% w/v.
Docusate
Sodium
is
an
anionic
surface
acting
agent
and
thus
penetrates into thick wax to soften
and facilitates easy removal of ear
wax.
Ask your pharmacist or doctor if
you have any questions about this
medicine.
BEFORE YOU USE SOLUWAX EAR
DROPS
_ _
_When you must not use it _
Do
not
use
SOLUWAX
EAR
DROPS if:
•
You are allergic (hypersensitive)
to Docusate Sodium or to any of
the other ingredients in this
medicine.
•
Your ear drum has been
perforated or experienced pain.
_Before you start to use it _
Tell your pharmacist or doctor if:
•
If
you
are
allergic
(hypersensitive)
to
Docusate
Sodium or to any of the other
ingredients in this medicine.
•
If
your
ear
drum
has
been
perforated or experienced pain.
Pregnancy and breast feeding:
•
Docusate
Sodium
is
absorbed
from
the
gastro-intestinal
tract
after
oral
administrati

Ciri produk

SOLUWAX EAR DROPS
DOCUSATE SODIUM 0.5% W/V EAR DROPS
Est. 1979
DESCRIPTION : A clear solution with characteristic odour.
PHARMACODYNAMICS : Docusate sodium is an anionic surface acting agent
and thus
penetrates into thick wax to soften and facilitate easy removal of ear
wax.
PHARMACOKINETICS : Docusate sodium is absorbed from the
gastro-intestinal tract after oral
administration and there is significant biliary excretion. It is also
excreted in breast milk.
INDICATION : For softening wax in the ear.
CONTRAINDICATION : Do not use this preparation in patients with known
hypersensitivity to
Docusate sodium. Docusate sodium must not be used if the ear drum has
been perforated.
Discontinue use if any pain is experienced.
SIDE EFFECT/ADVERSE REACTION : Cramping pains have been reported
occasionally and
liquid
preparation
sometimes
causes
nausea.
Docusate
sodium
increases
the
intestinal
absorption of other concomitantly administered drugs.
PRECAUTION/WARNING
:
Do
not
use
this
preparation
if
the
ear
drum
is
perforated.
Discontinue use if irritation of ear develops or persists.
RECOMMENDED DOSAGE : With the head tilted, fill the affected ear with
sufficient SOLUWAX
Ear Drops (approx. 10 drops) for two consecutive nights. Remain in
this position for 4 to 5
minutes. The ear wax should then be easily removed by normal
cleansing. If the ear wax is
unusually hard or if symptoms persist, consult your doctor or
pharmacist.
ROUTE OF ADMINISTRATION : Auricular (otic).
SYMPTOMS AND TREATMENT FOR OVERDOSE : Treatment after accidental
consumption is
purely symptomatic. Pain relieve in cramping pain and antinauseant for
treatment of nausea.
PACKING : Amber glass bottles of 10ml (with dropper) and 100ml.
STORAGE : For external use only. Keep container well closed. Protect
from light.
Store below 30°C. Keep out of reach of children.
Recommended shelf-life : 18 months.
MANUFACTURED BY :
HOE Pharmaceuticals Sdn. Bhd.
Lot 10, Jalan Sultan Mohamed 6, Bandar Sultan Suleiman,
42000 Port Klang, Selangor, MALAYSIA.
Revision date : August 2022