Summary of Product Characteristics (SmPC) - Otex ear drops 5%w/w
1 NAME OF THE MEDICINAL PRODUCT
Otex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea Hydrogen Peroxide 5.0 % w/w
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Ear drops
Clear, straw coloured viscous ear drops
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an aid in the removal of hardened ear wax
4.2 Posology and method of administration
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.
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
Keep Otex away from the eyes
For external use only
Replace cap after use, and return bottle to carton
4.5 Interaction with other medicinal products and other forms of interaction
Otex should not be used at the same time as anything else in the ear.
4.6 Pregnancy and lactation
No known side effects
4.7 Effects on ability to drive and use machines
Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear. Stop usage if irritation or pain occurs.
4.8 Undesirable 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.
4.9 Overdose
No adverse effects
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
No special information
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
8-Hydroxyquinoline
Glycerol
6.2 Incompatibilities
None known
6.3 Shelf life
18 months. Discard 4 weeks after first opening.
6.4 Special precautions for storage
Store upright in a cool place and keep out of sunlight. Store below 25°C.
Replace cap after use.
6.5 Nature and contents of container
- a) 12 ml amber glass bottle incorporating a specially designed polythene pipette applicator enclosed in a polypropylene screw cap
- b) 5 ml low density polyethylene bottle with low density polyethylene nozzle applicator and tamper-evident polypropylene screw cap*
- c) 15 ml low density polyethylene bottle with low density polyethylene nozzle applicator and tamper-evident polypropylene screw cap*
*plus intervening bottle capacities within the range 5 ml to 15 ml, all of exactly the same material.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin, Hertfordshire
SG4 7QR, England
8 MARKETING AUTHORISATION NUMBER
PL 00173/0151
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/10/1992 / 14/04/2003
10 DATE OF REVISION OF THE TEXT
21/06/2024