EXTEROL Ear drops, solution Ref.[49929] Active ingredients: Urea

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR

4.3. Contraindications

Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is 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 Exterol 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 Exterol 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

Exterol 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

None known.

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.

6.2. Incompatibilities

None known.

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