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OTOMIZE

Active substance: NEOMYCIN SULPHATE

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•  nywhere other than in the ear. Do not
a
inhale in the mouth or nose or spray near
the eyes.
•  f you have a perforated ear drum or
i
have a grommet fitted in the affected ear.
• n children under 2 years of age
i

dexamethasone,
neomycin sulphate,
acetic acid

Take special care with Otomize

Please read right through this leaflet
before you start using this medicine. This
medicine is available on prescription only.
•  eep this leaflet you may need to read it
K
again.
• f you have any further questions, ask your
I
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

•  xcessive use (high doses or prolonged
E
use) of this product on open wounds or
damaged skin may cause deafness. This is
particularly important to consider when used
on children.
•  o not swallow any of the spray.
D
If swallowed (especially by a child) contact
your doctor or casualty department
immediately.
Pregnancy and breast feeding
Talk to your doctor before using Otomize
if you 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.

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

3. How to use Otomize

Before using a new bottle of Otomize:
•  hake well before use.
S
•  ress the pump down several times until
P
you get a fine spray.
•  ake sure you do not point the nozzle at
M
yourself or someone else.
•  ach time the pump is pressed down one
E
measured dose will be delivered.
•  f you have not used Otomize for more
I
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.

Acetic Acid Neomycin Sulphate Dexamethasone Otomise PIL UK
item no:

AAAH9618

dimensions: 120 x 130

print proof no:

5

pharmacode:

origination date: 20.5.15
approved for print/date

min pt size:

colours/plates:
1.

black

2.
3.
4.

7 pt

originated by:

db

revision date:

5.6.15

Technical Approval

revised by:

db

date sent:

20.5.15

supplier:

Purna Pharma BE

approved:

26.5.15

5.
6.
Non Printing Colours
1. profile
2.
3.

Using Otomize:
Adults and children over the age of
2 years.
•  hake well before use.
S
•  lace the nozzle tip gently into your ear.
P
•  ress the pump once to deliver the correct
P
dose.
•  pray one measured dose into each
S
affected ear three times a day, or as
directed by your doctor.
•  f you forget to use Otomize do not
I
worry. Use it as soon as you remember then
go on as before.
•  he nozzle tip must always be in place
T
when you use the spray. You can remove
it for cleaning but always click it back into
place afterwards.
•  ontinue using Otomize until two
C
days after symptoms have gone.
•  top using the product and
S
consult a doctor if your condition
worsens or does not improve after
7 days treatment.
•  o not use more than the
D
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:
•  ensitivity or allergic reactions (irritation or
S
a rash).
The following side effects may also occur, but
usually go away after the first few days of
treatment:
•  emporary stinging or a burning sensation.
T
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 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 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 2015.
Otomize is a registered trade mark of Forest
Laboratories UK Ltd.

AAAH9618

Acetic Acid Neomycin Sulphate Dexamethasone Otomise PIL UK
item no:

AAAH9618

dimensions: 120 x 130

print proof no:

5

pharmacode:

origination date: 20.5.15
approved for print/date

min pt size:

colours/plates:
1.

black

2.
3.
4.

7 pt

originated by:

db

revision date:

5.6.15

Technical Approval

revised by:

db

date sent:

20.5.15

supplier:

Purna Pharma BE

approved:

26.5.15

5.
6.
Non Printing Colours
1. profile
2.
3.

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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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