AUDAX Ear drops, solution Ref.[49774] Active ingredients: Choline salicylate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

4.1. Therapeutic indications

For relief of pain in otitis externa and media, furuncles and other local inflammation, softening of earwax and aid to earwax removal.

4.2. Posology and method of administration

Topical into ear.

Place the head on one side with the affected ear uppermost. Completely fill the external auditory canal with drops. The ear should be plugged with cotton wool soaked with the eardrops or a wick may be inserted if preferred. Audax Ear Drops should be instilled every 3 to 4 hours until permanent relief of symptoms is obtained.

4.9. Overdose

Each bottle of Audax Ear Drops contains 1.6g of choline salicylate equivalent to 1.2g of aspirin. Accidental or deliberate ingestion of the contents of a bottle of Audax Ear Drops is therefore only of concern in small infants.

In such cases, signs of intoxification may include dizziness, tinnitus, sweating, vomiting, confusion and hyperventilation. Gross overdosage may lead to central nervous system depression.

Management should include, as appropriate, induced vomiting, correction of fluid and electrolyte balance and measurement of plasma salicylate levels. At concentrations in excess of 300 mg/litre measures such as forced alkaline diuresis and haemodialysis to enhance clearance may be appropriate.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Amber glass bottle (Ph.Eur.Type III), with a polypropylene pipette, containing 8 ml or 10 ml of product.

6.6. Special precautions for disposal and other handling

No special requirements.

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