WAXSOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOCUSATE SODIUM

Available from:

Meda Health Sales Ireland Limited

ATC code:

A06AA02

INN (International Name):

DOCUSATE SODIUM

Dosage:

0.5 %w/v

Pharmaceutical form:

Ear Drops Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

docusate sodium

Authorization status:

Marketed

Authorization date:

2011-05-03

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR
THE USER
0.5% W/V
EAR DROPS
SOLUTION
Docusate Sodium
READ ALL OF THIS LEAFLET CARE-
FULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFOR
-
MATION FOR YOU.
•
Keep this leaflet. You may
need to read it again.
•
If you have any further ques
-
tions, ask your doctor or
pharmacist.
•
This medicine has been pre
-
scribed for you. Do not pass
it on to others. It may harm
them, even if their signs of
illness are the same as yours.
•
If you get any side effects,
talk to your doctor or phar
-
macist.
This
includes
any
possible
side
effects
not
listed in this leaflet.
IN THIS LEAFLET:
1.
What WAXSOL is and what
it is used for
2.
What you need to know
before you use Waxsol
3.
How to use WAXSOL
4.
Possible side effects
5.
How to store WAXSOL
6.
Contents of the pack and
other information
1. WHAT WAXSOL IS
AND WHAT IT IS USED
FOR
WAXSOL
is
used
to
help
remove ear wax in adults, the
elderly and children. The drops
help to clear your ear canal if it
is blocked with wax by soften
-
ing it and breaking it up.
2. WHAT YOU NEED TO
KNOW BEFORE YOU
USE WAXSOL
DO NOT USE WAXSOL:
•
If you are allergic (hypersen
-
sitive) to docusate sodium or
any of the other ingredients
of WAXSOL.
•
if
you
have
a
perforated
(burst) ear drum
•
if your ear is sore inside
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma
-
cist before using WAXSOL.
•
If pain or inflammation is ex
-
perienced treatment should
be discontinued
•
As WAXSOL contains par
-
ahydroxybenzoates, allergic
reactions (possibly delayed)
may be experienced.
OTHER MEDICINES AND
WAXSOL
Please tell your doctor or phar
-
macist if you are taking or have
recently taken any other medi
-
cines, including medicines ob-
tained without a prescription.
PREGNANCY AND BREAST-FEED-
ING
Ask your doctor or pharmacist
for advice before taking this
medicine
•
WAXSOL can be used if you
are pregnant or thinking of
becoming pregnant
•
Waxsol can be used if you
are breastfeeding
DRIVING AND USING MACHINES
WAXSOL should not a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
WAXSOL 0.5% w/v Ear Drops Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
WAXSOL Ear Drops contain the following active ingredient:
Docusate Sodium 0.5% w/v.
Excipients: Contains parahydroxybenzoates max 0.6% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, solution (Ear Drops)
A clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
WAXSOL Ear Drops are indicated as an aid in the removal of ear wax.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dose and dosage schedules:
_ADULTS (INCLUDING THE ELDERLY):_ The application of ear drops
sufficient to fill the affected ear on not more than two
consecutive nights, prior to attending syringing if this is necessary.
If the problem persists patients should consult their
doctor.
_CHILDREN:_ (6 – 12 years): As for adult dose.
4.3 CONTRAINDICATIONS
Perforation of the ear drum or inflammation of the ear.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If
pain
or
inflammation
is
experienced,
treatment
should
be
discontinued.
As
WAXSOL
contains
parahydroxybenzoates, allergic reactions (possibly delayed) may be
experienced.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
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4.6 FERTILITY, P