OTEX EAR DROPS 5%W/W
Active substance(s): UREA PEROXIDE
Information for the user
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:
What Otex is and what it is used for
Before you use Otex
How to use Otex
Possible side effects
How to store Otex
1. WHAT OTEX IS AND WHAT IT IS
• 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
• 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
• 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
• 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
ear - such as pain, swelling, discharge,
cause dizziness, and this may be made
infection or tinnitus (ringing sounds in
worse by using the ear drops (see
Section 4). If you are affected, do not
drive or use machinery.
Taking other medicines and using
• 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 (such as other ear drops or a
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
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
• 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
• 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
• 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
If you have any further questions on
the use of this product, ask your doctor
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
• 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).
• 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.
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 via the
Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can
help provide more information on the safety
of this medicine.
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
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
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 revised in April 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
Otex Ear Drops, 00173/0151.
This is a service provided by the Royal
National Institute of Blind People (RNIB).
3. HOW TO USE OTEX
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.