Skip to Content

OTOMIZE

Active substance(s): DEXAMETHASONE / GLACIAL ACETIC ACID / NEOMYCIN SULFATE / NEOMYCIN SULPHATE / DEXAMETHASONE / GLACIAL ACETIC ACID / NEOMYCIN SULFATE / NEOMYCIN SULPHATE / DEXAMETHASONE / GLACIAL ACETIC ACID / NEOMYCIN SULFATE / NEOMYCIN SULPHATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

dexamethasone,
neomycin sulfate,
acetic acid
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 pharmacist.
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

1. What Otomize does

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 sulfate 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 sulfate, acetic
acid or to any of the other ingredients (listed
in Section 6).
• anywhere other than in the ear. Do not
inhale in the mouth or nose or 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.
• Contact your doctor if you experience blurred
vision or other visual disturbances.
Pregnancy and breast feeding
Talk to your doctor before using Otomize
if you are pregnant, trying to become
pregnant, or breast feeding.

3. How to use Otomize

Before using a new bottle of Otomize:
• 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.
• 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 experience:
• 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.
The following side effect has also been reported:
• Blurred vision.
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.

Do not store above 25ºC.
Do not freeze.
Keep container upright in the outer carton.
Use within one month of first use.

6. Further information

Active ingredients Dexamethasone 0.1% w/w,
Neomycin Sulfate 0.5% w/w (3250 IU/ml), Acetic
Acid (glacial) 2.0% w/w.
Other ingredients Macrogol (2) stearyl ether,
macrogol (20) stearyl ether, stearyl alcohol,
methyl parahydroxybenzoate (E 218), propyl
parahydroxybenzoate (E 216) and purified
water.
Otomize is supplied in packs containing 5ml
as an aqueous suspension. The spray is nonpressurised 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.
PL00108/0332
Legal category: Prescription Only Medicine.
This leaflet was last revised in June 2017.
Otomize is a registered trade mark of Forest
Laboratories UK Ltd.

5. How to store Otomize

Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date
shown on the pack.

AAAJ8922

Expand Transcript

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.

Hide