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EARCALM SPRAY

Active substance(s): GLACIAL ACETIC ACID

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10 mm
Pharmacode: 10mm high
First Bar/Left hand bar
starts 10mm down.

40 mm
120 mm

10 mm

120 mm

In this leaflet:

1. What EarCalm does
2. Check before you use EarCalm
3. How to use EarCalm
4. Possible side effects
5. How to store EarCalm
6. Further information

• if you have ever had an allergic reaction to
acetic acid or any of the other ingredients
(listed in Section 6)
• if you are under 12 years
• anywhere other than in the ear. Do not
inhale in the mouth or nose or spray near
the eyes.

Take special care with
EarCalm
• If you have a perforated eardrum, or if you
think you may have, consult your doctor
before you use this medicine.
• Stop treatment and call your doctor:
• if you get any pain
• if symptoms worsen or do not improve
within 48 hours
• if hearing is affected.
• Do not use for more than 7 days.

130 mm

Please read right through this leaflet before
you start using this medicine. This medicine
is available without prescription, but you still
need to use EarCalm carefully to get the best
results from it.
• Keep this leaflet you may need to read it
again.
• If you have any further questions, ask your
pharmacist.
• Do not use for more than 7 days.

1. What EarCalm does

Using EarCalm

Do not use EarCalm:

Acetic acid 2%

130 mm

Pharmacode travel direction

30 mm

2. Check before you use
EarCalm

4. Possible side effects

3. How to use EarCalm

Like all medicines, EarCalm can have side
effects, but not everybody gets them:
• sensitivity or allergy. If this happens, stop
using the spray.
• temporary stinging or a burning sensation
for the first few days of treatment

Before using a new bottle of EarCalm

EarCalm is used for the treatment of minor
infections of the outer ear.
The active ingredient is acetic acid, an
antibacterial agent that helps clear such
infections.

• 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.

• Shake well before use
• Press the pump down several times until
you get a fine spray
• Make sure you do not point the nozzle at
yourself or someone else
• The bottle is now ready for use
• Each time the pump is pressed down one
measured dose will be delivered
• If you have not used EarCalm for more
than a week, press the pump a few times
until you get a fine spray again, and then
follow the instructions above.
For external use only.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store 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 25°C.
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
Forest Laboratories UK Limited, Whiddon
Valley, Barnstaple, North Devon, EX32 8NS,
United Kingdom 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 April 2015.
EarCalm is a registered trademark of
Forest Laboratories UK Ltd.

AAAH8818

AAAH8818

Front

Back

colours/plates

Acetic Acid (EarCalm) 2% PIL - UK

1. black

item no: AAAH8818

dimensions: 120 x 130

print proof no: 1

pharmacode:

origination date: 22.04.15

min pt size: 7.5

originated by: S.Anson
approved for print/date

2.
3.
4.
5.
6.

revision date:

Technical Approval

revised by:

date sent: 22.05.15

supplier: Purna Pharma BE

technically app. date: 29.04.15

Non Printing Colours
1. Profile
2.

3.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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