EARCALM Spray Ref.[6057] Active ingredients: Acetic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom

Contraindications

The product should not be used in patients with a known sensitivity to any of the ingredients.

Not recommended for children under 12 years of age without medical advice.

Special warnings and precautions for use

Do not use for more than 7 days. Avoid spraying near the eyes.

If pain occurs during use, or if symptoms worsen or do not improve within 48 hours, or if your hearing becomes impaired, stop treatment and consult your doctor.

Patients who are known to have a perforated ear drum should only use the product under medical supervision.

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

There are no known restrictions to the use of the product in pregnancy and lactation.

Effects on ability to drive and use machines

Unresolved ear problems could themselves effect driving ability.

Undesirable effects

Some patients may experience a transient stinging or burning sensation after dosing for the first few days of treatment.

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.

Incompatibilities

None known.

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