PACKAGE LEAFLET

Information for the user

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 • if you have tried to remove the ear wax
2. Before you use Otex using fingernails, cotton buds or other
3. How to use Otex implements. (This is because you might
have damaged the delicate inner lining
4. Possible side effects of the ear, leading to swelling or
5. How to store Otex infection.) This could make it painful
6. Further information to use the ear drops.
• if you have had your ear syringed in the
1. WHAT OTEX IS AND WHAT IT IS last 2 to 3 days – this could also make
USED FOR it painful to use the eardrops.
• Otex ear drops are used to help remove Take special care when using this product:
hardened wax from the ear canal. • If you are in any doubt whether this
• Otex is suitable for use by adults, product is suitable for you, talk to your
children and the elderly. doctor, nurse or pharmacist before use.

• The active ingredient is urea hydrogen If Otex gets into the eyes
peroxide. It works by breaking down the • Take care to avoid getting Otex in
ear wax into small pieces. your eyes.
• Excessive, hardened ear wax is quite • If this happens, rinse the eye immediately
common. It causes problems when with water for 10 to 15 minutes, holding
it builds up and blocks the ear canal. the eyelids apart and avoiding getting
The first symptom is usually a feeling the rinse liquid in the other eye.
of discomfort and fullness in the ear. • Tell your doctor or pharmacist if irritation
This can become painful and cause persists.
dizziness and some loss of hearing if
left untreated. 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
ear syringing. same time you are putting anything else
in the ear (such as other ear drops or a
2. BEFORE YOU USE OTEX hearing aid).
Do not use Otex: • Otex is not known to affect, or to be
• if you are allergic (hypersensitive) to urea affected by, any other kinds of medicines
hydrogen peroxide or any of the other that you may be using.
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
• if you are also putting anything else in preparations for many years, without reports
the ear (such as other ear drops or a of problems. However, safety trials have not
hearing aid). been conducted.

• if your ear drum is (or has been) damaged. Driving and using machinery
• if you suffer from dizziness. Using this product is not known to affect
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
SD36/21/1 202369

the ear). Section 4). If you are affected, do not

drive or use machinery.

Continued overleaf
3. HOW TO USE OTEX Reporting of side effects. If you get any
Only use Otex in the ears. side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side
For adults, children and the elderly: effects not listed in this leaflet.
Repeat the following once or twice daily, You can also report side effects directly
normally for 3 to 4 days, until you notice via the Yellow Card Scheme at:
an improvement in your hearing and less www.mhra.gov.uk/yellowcard or search
discomfort: for MHRA Yellow Card in the Google Play
• Turn the cap anti-clockwise. or Apple App Store. By reporting side effects
(This will break the seal when you use you can help provide more information on the
the drops for the first time.) safety of this medicine.
• Remove the cap to reveal the 5. HOW TO STORE OTEX
applicator nozzle.
• Keep out of the sight and reach of children.
• Tilt your head and gently squeeze
up to 5 drops into the ear. • Do not use after the expiry date shown
on the bottle and the carton. The expiry
• Keep your head tilted for a few minutes date refers to the last day of that month.
so that the drops stay in the ear.
• Once opened, do not keep the bottle for
• Then wipe away any surplus with a tissue. longer than 4 weeks.
• Repeat in the other ear, if necessary. • Store below 25°C.
• Wash hands after use. • Store in a cool place and keep out
• Do not “plug” the ears with loose of sunlight.
cotton wool. • Always replace the cap tightly after use.
• Always replace the cap after use and • Store the bottle upright in the outer
return the bottle to the carton. carton to avoid spillage.
• Medicines should not be disposed of via
Note that in some cases excessive ear wastewater or household waste. Ask your
wax may persist for more than 3 to 4 days, pharmacist how to dispose of medicines
despite softening. If the wax is very hard, no longer required. These measures will
the ear drops alone may not be able to help to protect the environment.
clear the ear canal. This may cause some
temporary loss of hearing. In these cases 6. FURTHER INFORMATION
you should consult your doctor, nurse or ABOUT OTEX
pharmacist for further advice. What Otex contains:
If you use more Otex than you should The active ingredient is urea
Do not worry if you use too much Otex. hydrogen peroxide (5% w/w).
Simply wipe away any surplus running The other ingredients are
from the ear with a tissue. 8-hydroxyquinoline and glycerol.
If you forget to use Otex What Otex looks like and contents
of the pack
Do not worry if you occasionally forget to use
Otex. When you remember, just carry on using • The bottle contains 8ml of Otex ear
this product once or twice daily as usual. drops. The plastic bottle is fitted with
a dropper and screwcap.
If you have any further questions on the use
of this product, ask your doctor or pharmacist. • The product is a clear, straw coloured
solution.
4. POSSIBLE SIDE EFFECTS The Marketing Authorisation holder is
Like all medicines, Otex can cause side Diomed Developments Ltd, Hitchin, Herts,
effects, although not everybody gets them. SG4 7QR, UK.
• A temporary mild bubbling sensation in the The Manufacturer is Aeropak, Viking Road,
ear can occur (due to the release of oxygen Great Yarmouth, Norfolk, NR31 0NU, UK.
as the drops break down the ear wax). This leaflet was last revised in
• The ear drops can make the symptoms September 2021.
of excessive ear wax worse, including
To listen to or request a copy of this leaflet
some discomfort, irritation or pain,
in Braille, large print or audio, please call
loss of hearing, dizziness and tinnitus
free of charge: 0800 198 5000 (UK only).
(ringing sound in the ear).
Please be ready to give the following
• Very rarely, an unpleasant taste has
information: Otex Ear Drops, 00173/0151.
been reported. Stop using the ear drops
immediately if this happens and tell This is a service provided by the Royal
your doctor. National Institute of Blind People (RNIB).
Stop using this product and tell your doctor
or pharmacist if:
SD36/21/1 202369

• symptoms persist or,

• if any of the side effects get serious
or you notice any other side effects not
mentioned in this leaflet.