Summary of Product Characteristics Updated 22-Feb-2021 | Diomed Developments Limited
Urea hydrogen peroxide 5.0% w/w
For excipients, see 6.1.
Clear, straw coloured viscous ear drops.
As an aid in the removal of hardened ear wax.
For adults, children and the elderly:
Instill up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus.
Repeat once or twice daily for at least 3 to 4 days, or as required.
Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is, or has been, any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus).
Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful. For similar reasons, it is inadvisable to use Otex within 2 to 3 days of syringing.
Do not use where there is a history of ear problems, unless under close medical supervision.
Do not use if sensitive to any of the ingredients.
Keep Otex away from the eyes.
For external use only.
Replace cap after use, and return bottle to carton.
Otex should not be used at the same time as anything else in the ear.
No known side effects.
Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear. Stop usage if irritation or pain occurs.
Instillation of ear drops can aggravate the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus. Very rarely, unpleasant taste has been reported. If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No adverse effects.
After insertion of the drops into the ear, the urea hydrogen peroxide complex liberates oxygen which acts to break up the hardened wax. The hydrogen peroxide component is also a cerumenolytic. Its action as an antiseptic, especially in sites with relative anaerobiosis, is well known. The glycerol and urea assist in softening the wax, so that it may more easily be removed from the ear, either with or without syringing. The urea also acts as a mild keratolytic, helping to reduce the keratin-load in the debris. With less debris, the other components are able to reach the skin under the debris and exert their action.
Otex is intended only for the treatment of impacted wax in the external auditory canal. The ingredients of the formulation are therefore readily available for intimate contact with the affected area, as the drops are instilled into the ear and retained therein for several minutes by tilting the head.
No special information.
24 months. Discard 4 weeks after first opening.
Store upright in a cool place and keep out of sunlight.
Store below 25°C.
Replace cap after use.
a) 12 ml amber glass bottle incorporating a specially designed polythene pipette applicator enclosed in a polypropylene screw cap.
b) 15 ml low density polyethylene bottle with low density polyethylene nozzle applicator and tamper-evident screw cap.*
c) 5 ml low density polyethylene bottle with low density polyethylene nozzle applicator and tamper-evident screw cap.*
* Plus intervening bottle capacities within the range 5 ml to 15 ml, all of exactly the same material.
Supplied as original packs (OP).
Diomed Developments Limited
T/A Dermal Laboratories
Hertfordshire SG4 7QR
29 October 1992/Unlimited validity (granted 22/07/2010 for 24/06/2007 renewal date)
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565