Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Acetic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
EarCalm Before using a new bottle of EarCalm
• • • 130 mm
Acetic acid 2%
• • • •
Shake well before use Place the nozzle tip gently into your ear Press the pump once to deliver the measured dose Spray one measured dose into each affected ear at least three times a day (morning, evening and after swimming, showering or bathing), or as directed by your doctor/pharmacist Leave at least 2 to 3 hours between doses Continue treatment until two days after symptoms have disappeared, but no longer than 7 days If you forget to use EarCalm do not worry. Use it as soon as you remember then go on as before The nozzle tip must be in place when you use the spray. You can remove it for cleaning but always click it back into place afterwards After use, wipe the nozzle tip with a tissue to remove any ear wax residue.
Like all medicines, EarCalm can have side effects, but not everybody gets them:
xxxxxx LCxxx FRONT / RECTO
BACK / VERSO
EarCalm Keep out of the reach and sight of children. Do not use this medicine after the 'EXP' date shown on the pack. Do not store above 25oC. Keep container upright in the outer carton. Use within one month of first use.
6. Further information Active ingredient 2% w/w Acetic Acid (glacial). Other ingredients Macrogol stearyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water. EarCalm is supplied in packs containing 5ml as an aqueous suspension. The spray is non-pressurised and does not contain CFCs. The marketing authorisation holder is Dexcel®-Pharma Ltd., 2nd Floor, Bourn, 1 Manor House Drive, Coventry, CV1 2FX, UK and all enquiries should be sent to this address. The manufacturer is Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in November 2025. EarCalm is a Trade Mark of Dexcel®-Pharma Ltd.
EarCalm Spray comes as spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in EarCalm Spray is acetic acid.
This leaflet reproduces the patient information leaflet approved for EarCalm Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.
Route of administration: Topical. For external aural use to the external auditory canal only.
Adults, children, aged 12 years and above, and the elderly.
For treatment of superficial infections of the outer ear: one metered dose (60 milligrams) to be administered directly into each affected ear at least three times daily (morning, evening and after swimming, showering or bathing). Maximum dosage frequency one spray every 2 - 3 hours.
Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.
Before using the product for the first time, prime the pump by depressing actuator 6 - 10 times until a fine spray is obtained. Use within 1 month of first actuation. If more than one week has elapsed since the last use, dispose of the contents of the pump chamber by 1 or 2 depressions of the actuator.
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.
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.
None known
There are no known restrictions to the use of the product in pregnancy and lactation
Unresolved ear problems could themselves effect driving ability
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.
Overdosage by this route is extremely unlikely.
If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.
Ask anything about EarCalm Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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