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

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.

•    Otex makes removal of ear wax easier, and in many cases avoids the need for ear syringing.

2.    BEFORE YOU USE OTEX

Do not use Otex:

•    if you are allergic (hypersensitive) to urea hydrogen peroxide or any of the other ingredients of Otex listed in Section 6.

•    if you have a history of ear problems, unless used under the close supervision of your doctor, nurse or pharmacist.

•    if you are also putting anything else in the ear (such as other ear drops or a hearing aid).

•    if your ear drum is (or has been) damaged.

•    if you suffer from dizziness.

•    if there is anything else wrong with your ear - such as pain, swelling, discharge, infection or tinnitus (ringing sounds in the ear).

•    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

•    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 hearing aid).

•    Otex is not known to affect, or to be affected by, any other kinds of medicines that you may be using.

Pregnancy and breast-feeding Otex 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 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, 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 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 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 following information:

Otex Ear Drops, 00173/0151.

This is a service provided by the Royal National Institute of Blind People (RNIB).