OTOMIZE

dexamefhasone, ¹ neomycin sulfate, ¹ 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 react it again.

•    If you have any further questions, ask your doctor or pharmacijst.

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 5. 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 nflammation. Neomycin sulfate is a broad spectrum antibiotic tp fight infections and acetic acid is an antibacterial agent that also nelps to clear infections.

2.    Check before you use Otomize

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Do not use Otomize:

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• if you have ever had an allergic reaction to dexamethasone, neomycin sulfate, acetic acid or to any of the ofher ingredients (listed in Section 6).

•    anywhere other than jin the ear. Do not

inhale in the mouth or nose or spray near the eyes.    i

•    if you have a perforated ear drum or

have a grommet fitted in the affected ear.

•    in children under 2 year^ 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.

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Pregnancy and breast feeding

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

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3. How to use Otomize

Before using a new bottle of Otomize:

•    Shake well before usd.

•    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.

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For external use only. i

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Using Otomize: i Adults and children over the age of 2 years.

•    Shake well before use.

•    Place the nozzle tip gdntly 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. '

H* 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.

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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).    i

The following side effects may also occur, but jsually go away after the first few days of treatment:    i

» Temporary stinging or a burning sensation.

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Reporting of side effects

f you get any side effects, talk to your doctor, oharmacist 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 3y reporting side effects you can help provide Tiore information on the safety of this Tiedicine.

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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, i

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 ingredients Dexamethasone 0.1 % w/w, Neomycin Sulfate 0.5% w/w (3250 lU/ml), Acetic Acid (glacial) 2.0%|w/w.

Other ingredients Macrogol (2) stearyl ether, macrogol (20) steariyl ether, stearyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216) and purified water.

Otomize is supplied in packs containing 5ml as an aqueous suspension¹. 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 Purina Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.

PLO0108/0332

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Legal category: Prescription Only Medicine. This leaflet was last revise|d in December 2015.

Otomize is a registered tfade mark of Forest Laboratories UK Ltd. ,

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