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OTOSPORIN EAR DROPS

Active substance(s): HYDROCORTISONE / NEOMYCIN SULPHATE / 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 because it contains
important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1 What Otosporin is and what it is used for
2 What you need to know before you use Otosporin
3 How to use Otosporin
4 Possible side effects
5 How to store Otosporin
6 Contents of the pack and other 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. What you need to know 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 this medicine
(see section 6)
• 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.

Conditions you need to look out for
Inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach
pain and/or fever.
Contact your doctor as soon as possible if you get
these symptoms.
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.
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.
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.
Otosporin ear drops contain cetostearyl
alcohol and methyl hydroxybenzoate, E218
Otosporin ear drops contains cetostearyl alcohol
which may cause local skin reactions (e.g. local
dermatitis) and methyl hydroxybenzoate, E218
which may cause allergic reactions (possibly
delayed).

3. How to use Otosporin
Always use this medicine exactly as your doctor
or pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure.
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. If you
accidentally get the drops in your eyes, rinse
thoroughly with cold water.
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.
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, this medicine 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 with swelling. This
may be due to your skin not healing properly.
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.
Some patients have also reported experiencing the
following rare side effects (may affect up to 1 in
1,000 people):
• headache
• flaking skin in areas where you have applied
Otosporin
• thinning of the skin, which may bruise easily
• red spots on your skin that may appear
“spidery”

• lines on your skin that look like stretch marks
• existing skin conditions such as eczema
getting worse
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
meore information on the safety of this medicine.
5. How to store Otosporin
• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine 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.
• Store below 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.
6. Contents of the pack and other
information
What Otosporin contains
• The active substances per ml are polymyxin B
sulphate 10,000 IU, neomycin sulphate 3,400
IU and hydrocortisone 1% w/v.
• The other ingredients are cetostearyl alcohol,
sorbitan monolaurate, polysorbate 20, methyl
hydroxybenzoate, E218, 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 either 5 ml or 10 ml
of a milky-white liquid.
Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder: Phoenix Labs,
Suite 12, Bunkilla Plaza, Bracetown Business Park,
Clonee, Co. Meath, Ireland
Manufacturer: Aspen Bad Oldesloe GmbH, Bad
Oldesloe, Germany
Leaflet date: January 2015

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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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