- urea hydrogen peroxide
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
Otex Ear Drops
Information for the user
Otex® 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
2. BEFORE YOU USE OTEX
Do not use Otex:
Take special care when using this product:
If Otex gets into the eyes
Taking other medicines and using hearing aids
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:
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.
Stop using this product and tell your doctor or pharmacist if:
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
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 Marketing Authorisation holder is
The Manufacturer is
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).
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565