Document: document 2 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9
• document 10

---

Package Leaflet: Information for the user BACTROBAN® 2% OINTMENT

mupirocin    MOCK UP

4 Possible side effects

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

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 of the 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 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 accidently, 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.

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 require emergency treatment.

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 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

•    Store below 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.

•    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 Bactroban contains Active ingredient:

The name of your medication is Bactroban® Ointment and it contains Mupirocin 2% w/w in a water soluble base.

Inactive ingredients:

Polyethylene glycol.

What Bactroban looks like and contents of the pack

Bactroban® Ointment is translucent white in colour and is packed in a 15g aluminium tube with a plastic screw cap, in a cardboard container.

Marketing Authorisation Holder and Manufacturer

Bactroban® Ointment is manufactured by SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, Sussex RH10 2QJ and procured within the EU by the Product Licence holder Stephar (UK) Limited, 3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk NR31 0NN.

® Bactroban is a registered trademark of the GlaxoSmithKline group of companies.

3 How to use Bactroban

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.

Using this medicine

Do not mix Bactroban with any other external cream or ointment medicines on the infected area of your skin as this may reduce the effectiveness of Bactroban.

You usually apply Bactroban on your skin 2 to 3 times a day.

1.    Wash and dry your hands.

2.    Apply ointment to the infected area of your skin.

3.    You can cover the treated area with a plaster(s) or suitable dressing(s), unless your doctor has told you to leave it uncovered.

4.    Replace the cap on the tube and wash your hands.

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 questions on the use of this product, ask your doctor, nurse or pharmacist.