OTOSPORIN EAR DROPS

Active substance: POLYMYXIN B SULPHATE

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Package Leaflet: Information for the user

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.
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 6: 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.

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3 How to use Otosporin

5 How to store Otosporin

Always use Otosporin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

• Keep out of the reach and sight 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.
• 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.

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 3 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.

6 Further information

If you are due to have surgery
What Otosporin contains
Tell your doctor you have used Otosporin if you are • The active substances per ml are polymyxin B
due to have surgery. If Otosporin is absorbed into
sulphate 10,000 IU, neomycin sulphate 3,400 IU
the body in large amounts, the effects of medicines
and hydrocortisone 1% w/v.
used to relax muscles during surgery can last
• The other ingredients are cetostearyl alcohol,
longer or these effects could be stronger.
sorbitan laurate, polysorbate 20, methyl
hydroxybenzoate, dilute sulphuric acid and
If you use more Otosporin than you should
purified water.
If you think you have been using too much
Otosporin, tell your doctor or pharmacist.
What Otosporin looks like and
contents of the pack
If you forget to use Otosporin
Each carton has a plastic bottle with a nozzle and
If you forget a treatment, apply 3 drops to the
affected ear as soon as you remember. Then go on a screw cap, which contains either 5 ml or 10 ml
of a milky-white liquid.
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 usin the drops. This could mean you
g
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.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder: The Wellcome
Foundation Ltd, trading as GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex UB11 1BT.
Manufacturer: Aspen Bad Oldesloe GmbH
Bad Oldesloe, Germany
Other formats
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Otosporin Ear Drops
Reference number 00003/5106R
This is a service provided by the Royal National
Institute of the Blind.
Leaflet date: July 2011
Otosporin is a registered trademark of the
GlaxoSmithKline group of companies
© 2011 GlaxoSmithKline group of companies

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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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