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Bactroban 2% Ointment

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GlaxoSmithKline Package Leaflet: Information for the user

Bactroban® 2% Ointment

mupirocin

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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1    What Bactroban is and what it is used for

2    What you need to know before you use Bactroban

3    How to use Bactroban

4    Possible side effects

5    How to store Bactroban

6    Contents of the pack and other information


1 What Bactroban is and what it is used for


Bactroban 2% Ointment (called 'Bactroban' in this leaflet) contains a medicine called mupirocin. Bactroban is an antibiotic ointment.

It is used:

•    to treat skin infections on the skin such as

-    infected hair follicles which form pimples containing pus (“folliculitis"),

-    an infectious skin infection with blistering and crusting known as “impetigo" or

-    recurring boils (“furunculosis")

•    to kill various bacteria which cause other skin infections including Staphylococci, Streptococci and E. coli. This group includes MRSA (Methicillin Resistant Staphylococcus aureus).

•    This ointment is for external use on your skin only.


2 What you need to know before you use Bactroban


Do not use Bactroban:

• if you are allergic (hypersensitive) to mupirocin or any of the other ingredients of this medicine (listed in section 6) Do not use if the above applies to you. If you are not sure do not use this medicine. Talk to your doctor, nurse or pharmacist before using Bactroban.


Warnings and precautions

•    Bactroban can cause severe skin reactions or allergies. See 'Conditions to look out for' in Section 4

•    Bactroban is not suitable for use in your eyes, nose or around intravenous cannula ('drip') sites.

Thrush (a yeast yeast infection ) may develop if Bactroban is used for a long time. If this occurs, tell your doctor, pharmacist or nurse.

Keep the ointment away from your eyes.

- If the ointment gets into your eyes accidentally, wash them thoroughly with water.

There is a different preparation of Bactroban that is used to prevent or treat infections inside your nose.

Other medicines and Bactroban

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor or

pharmacist for advice before using this medicine.

If a cracked nipple is being treated, the ointment must be thoroughly washed off prior to breast-feeding. Bactroban Ointment contains polyethylene glycol

Talk to your doctor before using this medicine if you:

-    have kidney problems

-    have lare areas of open wounds or damaged skin to be treated


3 How to use Bactroban


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Front of Leaflet Page 1 of 2


How long should you use Bactroban for?

Use Bactroban for as long as your doctor has told you. If you are not sure, ask your doctor, nurse or pharmacist. The bacteria are normally cleared from your skin within 10 days of starting treatment. Do not use for more than 10 days. Throw away any ointment that is left over.

If you swallow any Bactroban If you swallow any of the ointment, speak to your doctor, nurse or pharmacist for advice.

If you forget to use Bactroban

•    If you forget to apply Bactroban, apply it as soon as you remember.

•    If your next dose is due within an hour, skip the missed dose.

•    Do not use a double dose to make up for a forgotten dose.

If you stop using Bactroban

If you stop using Bactroban too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, nurse or pharmacist when to stop using the ointment.

If you have any further guestions on the use of this product, ask your doctor, nurse or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Conditions to look out for

Severe skin reactions or allergies - If you develop a severe skin reaction or an allergy:

•    wash off the ointment

•    stop using it and

•    tell your doctor as soon as possible.

The following side effects may happen with this medicine:

Common (may affect up to 1 in 10 people)

•    Burning where the ointment is applied. Uncommon (may affect up to 1 in

100 people)

•    Itching, redness, stinging and dryness on your skin in the place where Bactroban is applied.

•    Allergic rash, itching, redness or soreness of the skin can also occur on other parts of your body.

Very rare (may affect up to 1 in 10,000 people) • Swollen face and/or difficulty breathing. This may be a sign of a serious allergic reaction that could reguire emergency treatment. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This include any possible side effects not listed in this leaflet. You can also report side effects direclty 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 Bactroban

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use Bactroban after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.

•    Do not use Bactroban if it looks different to normal.

•    Do not throw away 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.

Back of Leaflet Page 2 of 2


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6 Contents of the pack and other information

What Bactroban contains

•    The active substance is mupirocin. Each gram of ointment contains 20 mg mupirocin.

•    The other ingredients are polyethylene glycol 400 and polyethylene glycol 3350.

What Bactroban looks like and contents of the pack

•    Bactroban is an off-white, translucent ointment.

•    Bactroban is available in a 5 g and

15 g tube. Each tube comes in a carton. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder Beecham Group pic Stockley Park West, Uxbridge,

Middlesex UB11 1BT

Other formats:

To listen to or reguest 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    Bactroban 2%

Ointment

Reference number    00038/0319

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in: August 2013 Bactroban is a registered trademark of the GlaxoSmithKline group of companies.

© 2013 GlaxoSmithKline group of companies. All rights reserved.

GlaxoSmithKline

Manufacturer

Glaxo Wellcome Operations Harmire Road, Barnard Castle, Co Durham DL12 8DT

10000000118824