OTOMIZE

Active substance: NEOMYCIN SULPHATE

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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

2. Check before you use Otomize

For external use only.

Do not use Otomize:
dexamethasone,
neomycin sulphate,
acetic acid

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.

• 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).
• 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

Please read right through this leaflet before you
start using this medicine. This medicine is
Take special care with Otomize
available on prescription only.
• Keep this leaflet you may need to read it again.
• Excessive use (high doses or prolonged use) of
• If you have any further questions, ask your
this product on open wounds or damaged skin
doctor or pharmacist.
may cause deafness. This is particularly
important to consider when used on children.
• Do not swallow any of the spray. If swallowed
In this leaflet:
(especially by a child) contact your doctor or
1. What Otomize does
casualty department immediately.
2. Check before you use Otomize
3. How to use Otomize
4. Possible side effects
Pregnancy and breast feeding
5. How to store Otomize
Talk to your doctor before using Otomize if you
6. Further information
are pregnant, trying to become pregnant, or
breast feeding.

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 sulphate is a broad spectrum antibiotic
to fight infections and acetic acid is an
antibacterial agent that also helps to clear
infections.

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.

130 mm

130 mm

Pharmacode travel direction

30 mm

Using Otomize:

• 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.

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.
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 Sulphate 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
non-pressurised and does not contain CFCs.
The marketing authorisation holder is
Forest Laboratories UK Ltd, Dartford, Kent,
DA2 6SL, UK and all enquiries should be sent
to this address.
The manufacturer is Purna Pharmaceuticals NV,
Rijksweg 17, 2870 Puurs, Belgium.
PL 00108/0332
Legal category: Prescription Only Medicine.
This leaflet was last revised in November 2011.
Otomize is a registered trade mark of
Forest Laboratories UK Ltd.

If you do get any side effects, even those not
mentioned in this leaflet, tell your doctor or
pharmacist.
OT/LFT/UK/1/B

OT/LFT/UK/1/B

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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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