Otomize
S1717 LEAFLET Otomize 20140424
PACKAGE LEAFLET: INFORMATION FOR THE USER OTOMIZE EAR SPRAY
(dexamethasone, neomycin sulphate, glacial acetic acid)
Your medicine is Otomize ear spray but will be referred to as Otomize throughout the following leaflet.
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 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.
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
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
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.
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.
Pregnancy and breast feeding
Talk to your doctor before using Otomize if you are pregnant, trying to become pregnant, or breast feeding.
5. HOW TO STORE OTOMIZE
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not freeze.
• Keep container upright in the outer carton.
• Use within one month of first use.
• Do not use after the expiry date printed on the carton label or on the bottle label.
• If your doctor tells you to stop taking the medicine, please take them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
6. FURTHER INFORMATION
What Otomize contains
• The active substance in Otomize is Dexamethasone 0.1 %, Neomycin sulphate 3250 IU/ml, Glacial acetic acid 1.2mg/dose.
• The other ingredients are: Stearyl alcohol, Methylparaben E218, Propylparaben E216, Ethoxy (2) stearyl alcohol and Ethoxy (20) stearyl alcohol.
What Otomize looks like and contents of the pack
Otomize is a milky oil-in-water emulsion as a liquid ear spray, available in an amber glass bottle of 5ml capacity fitted with a spray device.
The spray is non-pressurised and does not contain CFCs.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Purna Pharmaceuticals, Belgium.
POM PL No: 19488/1717
Leaflet revision date: 24 April 2014
Otomize is a registered trade mark of Forest Laboratories UK Ltd.
S1717 LEAFLET Otomize 20140424