Otosporin Ear Drops
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Otosporin® Ear Drops
(polymyxin B sulphate, neomycin sulphate and hydrocortisone)
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Otosporin Ear
Drops but will be referred to as Otosporin
throughout the remainder of the leaflet.
In this leaflet:
1. What Otosporin is and what it is used for
2. Before you use Otosporin
3. How to use Otosporin
4. Possible side effects
5. How to store Otosporin
6. Further information
1. What Otosporin is and what it is used for
The name of your ear drops is Otosporin.
It is used to treat ear infections.
• Otosporin contains three medicines called: polymyxin B sulphate, neomycin sulphate and hydrocortisone.
• Polymyxin B sulphate and neomycin sulphate belong to a group of medicines called antibiotics. They kill the germs that can cause ear infections.
• Hydrocortisone belongs to a group of medicines called steroids. It helps to reduce the swelling and irritation caused by the infection.
2. Before you use Otosporin
Do not use Otosporin:
• If you are allergic (hypersensitive) to polymyxin B sulphate, neomycin sulphate, hydrocortisone or any of the other ingredients of Otosporin (see section; Further information)
• If you are allergic (hypersensitive) to aminoglycoside antibiotics such as framycetin, kanamycin or gentamicin.
• If you have a perforated ear drum
• If you have either a viral, fungal or tubercular (TB) infection.
• For a child under 3 years old.
Do not use if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before using Otosporin.
Take special care with Otosporin
Check with your doctor or pharmacist before using your medicine if:
• You have kidney problems. Your doctor may change how often you use Otosporin
• You have a long-standing infection of your outer ear.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Otosporin.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not use Otosporin with antibiotics such as framycetin, kanamycin or gentamicin, or other aminoglycosides.
Using them at the same time may increase the risk of hearing, nerve and kidney damage.
Pregnancy and breast-feeding
Do not use Otosporin if you are pregnant or plan to get pregnant.
Do not breast-feed while using Otosporin Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.
3. How to use Otosporin
Always use Otosporin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
POM
When using Otosporin
• Shake the closed bottle gently before each use.
• Clean and dry the ears
• Do not use soap, it may stop the medicine working
• Do not put the drops in your eyes
Adults and children over 3 years old
• Apply three drops into the affected ear up to four times a day, for up to 7 days
• Make sure you finish the course of Otosporin which your doctor has prescribed.
If you are due to have surgery
Tell your doctor you have used Otosporin if you are due to have surgery. If Otosporin is absorbed into the body in large amounts, the effects of medicines used to relax muscles during surgery can last longer or these effects could be stronger.
If you use more Otosporin than you should
If you think you have been using too much Otosporin, tell your doctor or pharmacist.
If you forget to use Otosporin
If you forget a treatment, apply 3 drops to the affected ear as soon as you remember. Then go on as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Otosporin can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
• Rarely, an allergic reaction to Otosporin can occur. Your ear infection may:
- seem to get worse instead of better
- become red, scaly and itchy.
You should stop using the drops and
talk to your doctor
• You may get a stinging or burning sensation when using the drops. This could mean you have a perforated ear drum. You should stop using the drops and talk to your doctor.
• If you use Otosporin in large quantities, it can affect your hearing, nerves and kidneys. This is unlikely when you use the normal dose of the ear drops.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Otosporin
• Keep out of the sight and reach of children
• Do not use Otosporin after the expiry date which is stated on the carton and the bottle label. This expiry date (EXP), refers to the last day of that month.
• Do not store above 25°C
• Otosporin should be stored in the carton to protect it from light.
• If the liquid shows any signs of discolouration or deterioration consult your pharmacist for advice.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information What Otopsorin contains:
• Each 1 ml contains polymyxin B sulphate 10,000 III, neomycin sulphate 3,400 III and hydrocortisone 1% w/v.
• The other ingredients are cetostearyl alcohol, sorbitan laurate, polysorbate 20, methyl hydroxybenzoate, dilute sulphuric acid and purified water.
What Otosporin looks like and contents of the pack
Each carton has a plastic bottle with a nozzle and a screw cap, which contains 10 ml of milky-white liquid.
Otosporin Ear Drops are manufactured by Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36 D-23843 Bad Oldesloe, Germany or Aspen Bad Oldesloe GmbH, Industriestrasse 32-36 D-23843 Bad Oldesloe, Germany.
Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/1263 Otosporin Ear Drops
Leaflet revised 13 June 2013
Otosporin is a registered trademark of Glaxo Group Ltd.
PP2/1263/V1