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NEOSPORIN EYE DROPS

Active substance(s): GRAMICIDIN / NEOMYCIN SULPHATE / POLYMYXIN B SULPHATE

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Reason for Submission: GDS 09 & QRD
Text Date: October 2013
MHRA Submission Date:
MHRA Approval Date:
Version No.: Issue 2 Draft 1
SPC Version No.: Issue 3 Draft 1
CO Number: N/A

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Package Leaflet: Information for the User

Neosporin® Eye Drops
polymyxin B sulphate, neomycin sulphate and gramicidin
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 only. 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. See section 4.
What is in this leaflet:
1
What Neosporin is and what it is used for
2
What you need to know before you use Neosporin
3
How to use Neosporin
4
Possible side effects
5
How to store Neosporin
6
Contents of the pack and other information

1
What Neosporin is and what it is used for
The name of your eye drops is Neosporin. It is used for the treatment and
prevention of bacterial infections of the eye. They may also be used before or after
an eye operation or after removal of a foreign body from the eye, to prevent
infection.
• Neosporin contains three medicines called: polymyxin B sulphate, neomycin
sulphate and gramicidin.
• Polymyxin B sulphate, neomycin sulphate and gramicidin belong to a group of
medicines called antibiotics. They kill the germs that can cause eye infections.

2
What you need to know before you use Neosporin
Do not use Neosporin:
• if you are allergic to polymyxin B sulphate, neomycin sulphate, gramicidin or any
of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to aminoglycoside antibiotics such as
framycetin, kanamycin or gentamicin
• if there is a possibility of Neosporin getting inside the eye itself, for example
before or during some types of surgery
• for long periods of time or in large quantities as this may effect your hearing,
nerves and kidneys, this is very unlikely to happen in normal use however
• whilst wearing contact lenses

• for a child under 2 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 Neosporin.
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 Neosporin
Check with your doctor or pharmacist before using your medicine if:
• you have kidney, nerve or ear problems. Your doctor may change how often you
use Neosporin
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before using Neosporin.
If you are due to have surgery
Tell your doctor you have used Neosporin if you are due to have surgery. If
Neosporin 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.
Other medicines and Neosporin
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 Neosporin 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
Use of Neosporin is not recommended if you are pregnant or breast-feeding.
If you are pregnant or breat-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medince.
Neosporin contains benzalkonium chloride
May cause eye irritiation. Avoid contact with soft contact lenses. Remove contact
lenses prior to application and wait at least 15 minutes before reinsertion. Known to
discolour soft contact lenses.

3
How to use Neosporin
Always use this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Adults and children over 2 years old
• apply 1 or 2 drops inside the lower eyelid two to four times a day, or more
frequently as requred, for up to 7 days. If you find this difficult it may be easier if
you use a mirror or for someone else to do this for you









try to avoid the tip of the bottle touching any part of the eye
after application, close your eye for 15 seconds and squeeze the top of your
nose for 1-2 minutes to stop the eye drops running through into your nose
in severe infections it might be necessary to start treatment with more frequent
application, up to every 15 to 30 minutes. Your doctor will tell you if you need to
use the drops this often
Neosporin should not be used in children less than 2 years old
wash your hands before and after using the drops
you should carry on using Neosporin for at least 2 days after your condition has
got better
if your condition has not improved after 7 days, you should return to your doctor

If you accidentally swallow some of the drops, or especially if you think that a child
has used or swalled any, you should contact your doctor.
If you use more Neosporin than you should
If you think you have been using too much Neosporin, tell your doctor or pharmacist.
If you forget to use Neosporin
If you forget a treatment, apply 1 or 2 drops to the affected eye as soon as you
remember, then go on as before. Do not use a double-dose to make up for a
forgotten dose.
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:
• An allergic reaction to Neosporin can occur. It is also possible for some types of
germs which are not killed by the drops to start causing a problem. In either case
your eye infection may seem to get worse instead of better. If this happens you
should stop using the drops and talk to your doctor
• If you use Neosporin in large quantities, it can affect your hearing, nerves and
kidneys. This is unlikely when you use the normal dose of the ear drops.
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 Neosporin
• 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
Do not store above 25°C
Keep the bottle tightly closed
Neosporin should be stored in the carton to protect it from light
Do not use for longer than one month after forst opening the bottle
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.

6
Contents of the pack and other information
What Neosporin contains
• The active substances per ml are polymyxin B sulphate 5,000 IU, neomycin
sulphate 1,700 IU and gramicidin 25 IU.
• The other ingredients are ethanol, propylene glycol, poloxamer 188, sodium
chloride, and purified water. Small amounts of sulfuric acid and/or sodium
hydroxide are used to adjust the pH.
What Neosporin looks like and contents of the pack
Each carton has a plastic bottle with a nozzle and a screw cap, which contains 5 ml
of liquid.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: The Wellcome Foundation Ltd., Stockley Park
West, Uxbridge, Middlesex UB11 1BT
Manufacturer: GlaxoSmithKline Manufacturing S.p.A., Parma, Italy.
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
Reference number

Neosporin Eye Drops
00003/5108R

This is a service provided by the Royal National Institute of Blind People.
Leaflet date: October 2013
Neosporin is a registered trademark of the GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved
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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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