Skip to Content



View full screen / Print PDF » Download PDF ⇩
Previously ®
By austino at
Otomize Ear Spray
Assessed against
(dexamethasone, neomycin sulphate, glacial acetic acid)
UK PIL dated June
Please read right through this leaflet before you start
using this medicine. This medicine is available on
prescription only.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or

other thanto
in the ear. Do not inhale in the
mouth or
or the
spray near the eyes.
if you have
a perforated ear
drum or have a grommet
fitted in the affected ear.
in children under 2 years of age.
Take special care with Otomize
Excessive use (high doses or prolonged use) of this
product on open wounds or damaged skin may cause
deafness. This is particularly important to consider when
used on children.
Do not swallow any of the spray. If swallowed
(especially by a child) contact your doctor or casualty
department immediately.

The name of your medicine is Otomize Ear Spray, but will be
referred to as Otomize throughout this leaflet.
In this leaflet:
1. What Otomize does
2. Check before you use Otomize
3. How to use Otomize
4. Possible side effects
5. How to store Otomize
6. Further information

Talk to your doctor before using Otomize if you are
pregnant, trying to become pregnant, or breast-feeding.

1. What Otomize does

3. How to use Otomize

Otomize is used to treat infection and inflammation of
the outer ear.
Otomize contains three active ingredients. Dexamethasone
is a topical corticosteroid medicine which is used to control
inflammation. Neomycin sulphate is a broad spectrum
antibiotic to fight infections and acetic acid is an antibacterial
agent that also helps to clear infections.

2. Check before you use Otomize
Do not use Otomize:
if you have ever had an allergic reaction to
dexamethasone, neomycin sulphate, acetic acid or to any
of the other ingredients (listed in Section 6).

Pregnancy and breast-feeding

Before using a new bottle of Otomize:
Shake well before use.
Press the pump down several times until you get a fine
Make sure you do not point the nozzle at yourself or
someone else.
Each time the pump is pressed down one measured dose
will be delivered.
If you have not used Otomize 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.

Using Otomize:
Adults and children over the age of
2 years.
Shake well before use.
Place the nozzle tip gently into your ear.
Press the pump once to deliver the correct dose.
Spray one measured dose into each affected ear
three times a day, or as directed by your doctor.
If you forget to use Otomize do not worry. Use it as
soon as you remember then go on as before.
The nozzle tip must always be in place when you use
the spray. You can remove it for cleaning but always click
it back into place afterwards.
Continue using Otomize until two days after
symptoms have gone.
Stop using the product and consult a doctor if
your condition worsens or does not improve
after 7 days treatment.
Do not use more than the recommended dose.

4. Possible side effects
Like all medicines, Otomize can have side effects, but not
everyone gets them.
Stop using the medicine and tell your doctor if you
Sensitivity or allergic reactions (irritation or a rash).
The following side effects may also occur, but usually go
away after the first few days of treatment:
Temporary stinging or a burning sensation.
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:

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

5. How to store Otomize
Keep out of the sight and reach of children.
Do not take your medicine after the expiry date which is
stated on the box/label after ‘Exp’. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep container upright in the outer carton.
Use within one month of first use.

6. Further information
Active ingredient is dexamethasone 0.1% w/w, neomycin
sulphate 0.5% w/w (3250IU/ml) and glacial acetic acid
Other ingredients are macrogol (2) stearyl ether, macrogol
(20) stearyl ether, stearyl alcohol, methyl
parahydroxybenzoate, propyl parahydroxybenzoate and
purified water.
Otomize is a milky oil-in-water emulsion as a liquid ear spray.
Otomize is for application to the external ear canal. This pack
contains 5ml of the emulsion. The spray is non-pressurised
and does not contain CFCs.
Manufactured by: Purna Pharmaceuticals, Belgium.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.

Otomize Ear Spray; PL 18799/1518
Leaflet date: 13.01.2016


Expand view ⇕

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.