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OTOMIZE EAR SPRAY

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

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OTOMIZE® EAR SPRAY
(dexamethasone / neomycin sulphate / glacial acetic acid)
The medicine is known by the above name but will be referred to as Otomize
throughout this leaflet.

Patient Information Leaflet

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.

Pregnancy and breast feeding

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.

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

In this leaflet:







1.
2.
3.
4.
5.
6.

What Otomize does
Check before you use Otomize
How to use Otomize
Possible side effects
How to store Otomize
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 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).

• 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.

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.
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 Otomize
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store the spray upright in the carton.
Do not use the spray after the expiry date printed on the carton or bottle label.
Use within one month of first use.
If the spray becomes discoloured or show any signs of deterioration you
should seek the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, please return any leftover
spray to the pharmacist for safe disposal. Only keep the spray if your doctor
tells you to.

6. Further information
What is in your medicine?
The name of your medicine is Otomize. Otomize is a milky liquid ear spray in
a glass bottle. It is an emulsion for application to the external ear canal. The
spray is non-pressurised and does not contain CFCs. This pack contains 5ml
as an aqueous suspension.
Each ml contains dexamethasone 0.1% w/w, neomycin sulphate 0.5% w/w
(3250 IU/ml) and glacial acetic acid 2% w/w.
Dexamethasone is an anti-inflammatory agent. Neomycin sulphate is a broad
spectrum antibiotic. Glacial acetic acid is an anti-bacterial agent and pH
adjuster.

Your medicine also contains the following inactive ingredients: macrogol (2)
stearyl ether, macrogol (20) stearyl ether, stearyl alcohol, methyl
parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) and
purified water.
Otomize is manufactured by Purna Pharmaceuticals, Belgium and is procured
from within the EU by the Product Licence Holder: Caseview (PL) Limited, 20
Alliance Court, Alliance Road, London W3 0RB and repackaged by O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1142

POM

Otomize® Ear Spray
Leaflet revision date (ref): 30/03/2016
Otomize is a registered trademark of Forest Laboratories UK Ltd, UK.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

OTOMIZE® EAR SPRAY
(dexamethasone / neomycin sulphate / glacial acetic acid)
The medicine is known by the above name but will be referred to as Otomize
throughout this leaflet.

Patient Information Leaflet

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.

Pregnancy and breast feeding

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.

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

In this leaflet:







1.
2.
3.
4.
5.
6.

What Otomize does
Check before you use Otomize
How to use Otomize
Possible side effects
How to store Otomize
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 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).

• 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.

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.
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 Otomize
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store the spray upright in the carton.
Do not use the spray after the expiry date printed on the carton or bottle label.
Use within one month of first use.
If the spray becomes discoloured or show any signs of deterioration you
should seek the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, please return any leftover
spray to the pharmacist for safe disposal. Only keep the spray if your doctor
tells you to.

6. Further information
What is in your medicine?
The name of your medicine is Otomize. Otomize is a milky liquid ear spray in
a glass bottle. It is an emulsion for application to the external ear canal. The
spray is non-pressurised and does not contain CFCs. This pack contains 5ml
as an aqueous suspension.
Each ml contains dexamethasone 0.1% w/w, neomycin sulphate 0.5% w/w
(3250 IU/ml) and glacial acetic acid 2% w/w.
Dexamethasone is an anti-inflammatory agent. Neomycin sulphate is a broad
spectrum antibiotic. Glacial acetic acid is an anti-bacterial agent and pH
adjuster.

Your medicine also contains the following inactive ingredients: macrogol (2)
stearyl ether, macrogol (20) stearyl ether, stearyl alcohol, methyl
parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) and
purified water.
Otomize is manufactured by Stafford-Miller Ltd., Plymouth, United Kingdom
and is procured from within the EU by the Product Licence Holder: Caseview
(PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and
repackaged by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
PL 13826/1142

POM

Otomize® Ear Spray
Leaflet revision date (ref): 30/03/2016
Otomize is a registered trademark of Forest Laboratories UK Ltd, UK.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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.

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