OTEX EAR DROPS 5%W/W

Active substance: UREA PEROXIDE

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PACKAGE LEAFLET
Information for the user

EAR DROPS

EAR DROPS

urea hydrogen peroxide 5% w/w

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.

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

1. WHAT OTEX IS AND WHAT IT IS
USED FOR
• Otex ear drops are used to help remove
hardened wax from the ear canal.
• Otex 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.









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.

• 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.
• 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:
• If you are in any doubt whether this
product is suitable for you, talk to your
doctor, nurse or pharmacist before use.
If Otex gets into the eyes
• Take care to avoid getting Otex in
your eyes.
• If this happens, rinse the eye immediately
with water for 10 to 15 minutes, holding
the eyelids apart and avoiding getting
the rinse liquid in the other eye.
• Tell your doctor or pharmacist if irritation
persists.

Taking other medicines and using
hearing aids
• Otex makes removal of ear wax easier,
and in many cases avoids the need for • It is important not to use Otex at the same
time you are putting anything else in the
ear syringing.
ear (such as other ear drops or a hearing
aid).
2. BEFORE YOU USE OTEX
• Otex is not known to affect, or to be
Do not use Otex:
affected by, any other kinds of medicines
• if you are allergic (hypersensitive) to urea
that you may be using.
hydrogen peroxide or any of the other
ingredients of Otex listed in Section 6.
Pregnancy and breast-feeding
• if you have a history of ear problems,
Otex can be used during pregnancy and
unless used under the close supervision
while breast-feeding. The ingredients have
of your doctor, nurse or pharmacist.
been in widespread use in this and similar
preparations for many years, without reports
• if you are also putting anything else in
of problems. However, safety trials have not
the ear (such as other ear drops or a
been conducted.
hearing aid).
• if your ear drum is (or has been) damaged. Driving and using machinery
Using this product is not known to affect
• if you suffer from dizziness.
your ability to drive or use machinery.
• if there is anything else wrong with your
However, the build up of ear wax can cause
ear - such as pain, swelling, discharge,
dizziness, and this may be made worse by
infection or tinnitus (ringing sounds in
using the ear drops (see Section 4). If you
the ear).
are affected, do not drive or use machinery.

SD8/07/6

Continued overleaf

3. HOW TO USE OTEX
Only use Otex 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:
• Turn the cap anti-clockwise.
(This will break the seal when you use
the drops for the first time).
• Remove the cap to reveal the
applicator nozzle.
• Tilt your head and gently squeeze
up to 5 drops into the ear.
• Keep your head tilted for a few minutes
so that the drops stay in the ear.
• Then wipe away any surplus with a tissue.
• Repeat in the other ear, if necessary.
• Wash hands after use.
• Do not “plug” the ears with loose
cotton wool.
• 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 Otex than you should
Do not worry if you use too much Otex.
Simply wipe away any surplus running from
the ear with a tissue.
If you forget to use Otex
Do not worry if you occasionally forget to
use Otex. 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, Otex can cause side
effects, although not everybody gets them.
• A temporary mild bubbling sensation
in the ear can occur (due to the release
of oxygen as the drops break down the
ear wax).
• The ear drops can make the symptoms
of excessive ear wax worse, including
some discomfort, irratation or pain, loss
of hearing, dizziness and tinnitus (ringing
sound in the ear).
• 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:
• symptoms persist or,
• if any of the side effects get serious
or you notice any other side effects not
mentioned in this leaflet.

5. HOW TO STORE OTEX
• 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 OTEX
What Otex contains:
The active ingredient is urea
hydrogen peroxide (5% w/w).
The other ingredients are
8-hydroxyquinoline and glycerol.
What Otex looks like and contents
of the pack
• The bottle contains 8ml of Otex ear
drops. The plastic bottle is fitted with
a dropper and screwcap.
• The product is a clear, straw coloured
solution.
The Marketing Authorisation holder is
Diomed Developments Ltd, Hitchin, Herts,
SG4 7QR, UK.
The Manufacturer is DDD Ltd,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This Leaflet was last approved in
September 2007.
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:
Otex Ear Drops, 00173/00151.
This is a service provided by the Royal
National Institute of Blind People (RNIB).

SD8/07/6

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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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