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EXTEROL 5%W/W EAR DROPS SOLUTION

Active substance(s): CARBAMIDE PEROXIDE

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PA CK A G E LEA F LET
Information for the user

Urea hydrogen peroxide
Please read all of this leaflet carefully before you start using this product.
Keep this leaflet. You may need to read it again. Ask your doctor, nurse or
pharmacist if you need more information or advice. You must contact a doctor
if your symptoms worsen or do not improve within a reasonable period.

1. WHAT EXTEROL IS AND
WHAT IT IS USED FOR
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Exterol ear drops are used to help
remove hardened wax from the ear
canal.
Exterol is suitable for use by
adults, children and the elderly.
The active ingredient is urea
hydrogen peroxide. It works by
breaking down the ear wax into
small pieces.
s Excessive, hardened ear wax
is quite common. It causes
problems when it builds up and
blocks the ear canal. The first
symptom is usually a feeling of
discomfort and fullness in the
ear. This can become painful
and cause dizziness and some
loss of hearing if left untreated.
s Exterol makes removal of ear wax
easier, and in many cases avoids
the need for ear syringing.

2. BEFORE YOU USE EXTEROL
Do not use Exterol:
s if you are allergic (hypersensitive)
to urea hydrogen peroxide or any
of the other ingredients of Exterol
listed in Section 6.
s if you have a history of ear
problems, unless used under the
close supervision of your doctor,
nurse or pharmacist.
s if you are also putting anything else
in the ear (such as other ear drops
or a hearing aid).
s if your ear drum is (or has been)
damaged.
s if you suffer from dizziness.
s if there is anything else wrong with
your ear - such as pain, swelling,
discharge, infection or tinnitus
(ringing sounds in the ear).
s if you have tried to remove the
ear wax using fingernails, cotton
buds or other implements. (This is
because you might have damaged
the delicate inner lining of the ear,
leading to swelling or infection.)

This could make it painful to use the
ear drops.
s if you have had your ear syringed in
the last 2 to 3 days – this could also
make it painful to use the eardrops.
Take special care when using this
product:
s If you are in any doubt whether this
product is suitable for you, talk to
your doctor, nurse or pharmacist
before use.
If Exterol gets into the eyes
s Take care to avoid getting Exterol
into your eyes.
s If this happens, rinse the eye
immediately with water for 10 to 15
minutes, holding the eyelids apart
and avoiding getting the rinse liquid
into the other eye.
s Tell your doctor or pharmacist if
irritation persists.
Taking other medicines and using
hearing aids
s It is important not to use Exterol
at the same time you are putting
anything else in the ear (such as
other ear drops or a hearing aid).
s Exterol is not known to affect, or to
be affected by, any other kinds of
medicines that you may be using.
Pregnancy and breast-feeding
Exterol can be used during pregnancy
and while breast-feeding. The
ingredients have been in widespread
use in this and similar preparations
for many years, without reports of
problems. However, safety trials have
not been conducted.
Driving and using machinery
Using this product is not known to affect
your ability to drive or use machinery.
However, the build up of ear wax can
cause dizziness, and this may be made
worse by using the ear drops (see
Section 4). If you are affected, do not
drive or use machinery.

3. HOW TO USE EXTEROL
Only use Exterol in the ears.
For adults, children and the elderly:
Repeat the following once or twice
daily, normally for 3 to 4 days, until
you notice an improvement in your
hearing and less discomfort:
s Turn the cap anti-clockwise. (This
will break the seal when you use the
drops for the first time).
continued…

SP11/15/1 201339

In this leaflet:
1. What Exterol is and what it is used for
2. Before you use Exterol
3. How to use Exterol
4. Possible side effects
5. How to store Exterol
6. Further information

Remove the cap to reveal the
applicator nozzle.
s Tilt your head and gently squeeze
up to 5 drops into the ear.
s Keep your head tilted for a few
minutes so that the drops stay in
the ear.
s Then wipe away any surplus with
a tissue.
s Repeat in the other ear, if necessary.
s Wash hands after use.
s Do not “plug” the ears with loose
cotton wool.
s Always replace the cap after use
and return the bottle to the carton.
Note that in some cases excessive ear
wax may persist for more than 3 to 4
days, despite softening. If the wax is
very hard, the ear drops alone may not
be able to clear the ear canal. This may
cause some temporary loss of hearing.
In these cases you should consult
your doctor, nurse or pharmacist for
further advice.
If you use more Exterol than you
should
Do not worry if you use too much
Exterol. Simply wipe away any surplus
running from the ear with a tissue.
If you forget to use Exterol
Do not worry if you occasionally forget
to use Exterol. When you remember,
just carry on using this product once or
twice daily as usual.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Exterol can cause
side effects, although not everybody
gets them.
s A temporary mild bubbling
sensation in the ear can occur
(due to the release of oxygen as
the drops break down the ear wax).
s The ear drops can make the
symptoms of excessive ear wax
worse, including some discomfort,
irritation or pain, loss of hearing,
dizziness and tinnitus (ringing sound
in the ear).
s Very rarely, an unpleasant taste has
been reported. Stop using the ear
drops immediately if this happens
and tell your doctor.
Stop using this product and tell your
doctor or pharmacist if:
s symptoms persist or,
s if any of the side effects get serious
or you notice any other side effects
not mentioned in this leaflet.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. You can also
report side effects directly (see details

below). By reporting side effects you
can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

5. HOW TO STORE EXTEROL
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Keep out of the reach and sight
of children.
Do not use after the expiry date
shown on the bottle and the carton.
The expiry date refers to the last
day of that month.
Once opened, do not keep the
bottle for longer than 4 weeks.
Do not store above 25°C.
Always replace the cap tightly
after use.
Store the bottle upright in the outer
carton to avoid spillage.
Medicines should not be disposed
of via wastewater or household
waste. Ask your pharmacist how
to dispose of medicines no longer
required. These measures will help
to protect the environment.

6. FURTHER INFORMATION
ABOUT EXTEROL
What Exterol contains:
The active ingredient is urea hydrogen
peroxide (5% w/w).
The other ingredients are
8-hydroxyquinoline and glycerol.
What Exterol looks like and contents
of the pack
s The bottle contains 8ml of Exterol
ear drops. The plastic bottle is fitted
with a dropper and screwcap.
s The product is a clear, straw
coloured solution.
The Marketing Authorisation holder is
Dermal Laboratories, Hitchin, Herts,
SG4 7QR, UK.
The Manufacturer is Fleet Laboratories
Ltd, 94 Rickmansworth Road, Watford,
Herts, WD18 7JJ, UK.
This Leaflet was last revised in
May 2015.
To listen to or request a copy of this
leaflet in Braille, large print or audio,
please call free of charge: 0800 198
5000 (UK only).
Please be ready to give the following
information: Exterol Ear Drops,
00173/0037.
This is a service provided by the
Royal National Institute of Blind People
(RNIB).

SP11/15/1 201339

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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