Patient Information Leaflet: Information for the User

Bactroban 20 mg/g Ointment

Mupirocin
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Bactroban is and what it is used for
What you need to know before using Bactroban
How to use Bactroban
Possible side effects
How to store Bactroban
Contents of the pack and other information

1. What Bactroban is and what it is used for

Bactroban 20 mg/g ointment (referred to as 'Bactroban' in this leaflet) contains a medicine called mupirocin.
Bactroban is an antibiotic ointment.
It is used for the topical treatment of primary and secondary pyoderma (skin infections caused by bacteria).

2. What you need to know before using Bactroban

Do not use Bactroban:

if you are allergic (hypersensitive) to mupirocin or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure whether this applies to you, do not use this medicine. Speak to your doctor or
pharmacist before using Bactroban.
Warnings and precautions
Talk to your doctor or pharmacist before using Bactroban

Bactroban may cause serious skin reactions or allergies. See 'Conditions to be aware of' in section 4. In such cases, your doctor will advise you to stop treatment and switch to an alternative treatment for infections.
Bactroban is not intended for ophthalmic use, intranasal use, or on the skin surrounding the insertion site of cannulas used for therapeutic treatments.
Rarely, antibiotic medicines such as Bactroban may cause inflammation of the colon (large intestine), resulting in diarrhoea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis). If you develop prolonged diarrhoea or experience abdominal cramps, contact your doctor immediately.

If you experience any of these symptoms, call your doctor as soon as possible.
If Bactroban is used for long periods, a fungal infection (e.g. candidiasis) may develop.
If this occurs, inform your doctor, pharmacist, or nurse.
Keep the ointment away from the eyes.
If the ointment accidentally comes into contact with the eyes, rinse them thoroughly with water.
.
Patients with renal impairment
If you suffer from moderate or severe renal impairment, your doctor will adjust the treatment dose.
Other medicines and Bactroban
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use Bactroban during pregnancy only if strictly necessary and under close medical supervision.
If treating a damaged nipple, the ointment must be thoroughly washed off before breastfeeding.
Driving and using machines
Bactroban does not affect the ability to drive or operate machinery.
Bactroban ointment contains polyethylene glycol
Talk to your doctor before using this medicine if you:

have kidney problems
have large open wounds or extensive areas of damaged skin to treat.

3. How to use Bactroban

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Do not mix Bactroban with other cream or ointment medicines on the infected area of skin, as this may reduce the effectiveness of Bactroban.
Apply Bactroban to the skin two or three times a day.

Wash and dry your hands thoroughly.
Apply a small amount of ointment to the infected area of skin.
The treated area may be covered with a plaster or other appropriate dressing, unless your doctor tells you to leave it uncovered.
Close the tube with the cap and wash your hands.

How long to use Bactroban?
Use Bactroban for the length of time prescribed by your doctor.
If you are unsure, consult your doctor or pharmacist.
Normally, bacteria are eliminated from the skin within 10 days of starting treatment. The duration of treatment should not exceed 10 days.
If you notice no improvement after one week of treatment, or if the infection worsens, inform your doctor.
Dispose of any remaining product after treatment is completed.

If you swallow Bactroban
If you accidentally swallow the ointment, seek advice from your doctor or pharmacist, or go to the nearest hospital. Take the medicine tube with you.

If you forget to use Bactroban

If you forget to apply Bactroban, apply it as soon as you remember.
If the next dose is due within one hour, skip the missed dose.
Do not use a double amount to make up for a forgotten dose.

If you stop using Bactroban
If you stop using Bactroban too early, not all bacteria may have been eliminated and they may continue to grow.
Consult your doctor or pharmacist when you stop using the ointment.
If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions to be aware of
Severe skin reactions or allergies
If you develop a severe skin reaction or an allergy, and particularly if you experience
facial swelling and breathing difficulties:

wash the ointment off thoroughly with plenty of water,
stop using it, and
contact your doctor as soon as possible.

The following side effects may occur with this medicine:
Common (may affect up to 1 in 10 people)

Burning sensation at the site where the ointment is applied.

Uncommon (may affect up to 1 in 100 people)

Itching, redness (erythema), skin rash, hives, stinging pain, and dryness at the site where Bactroban is applied, as well as in other areas of the body.
.

Very rare (may affect up to 1 in 10,000 people)
Facial swelling and/or difficulty breathing. These may be symptoms of a severe
generalized allergic reaction which may require emergency treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. 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 stated on the tube. The expiry date refers to the last day of that month.
Do not use Bactroban if it appears different from normal (see “Description of the appearance of Bactroban and contents of the pack”).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bactroban contains

The active substance is mupirocin. 1 g of ointment contains 20 mg of mupirocin.
The other components are polyethylene glycol 400, polyethylene glycol 3350.

Description of the appearance of Bactroban and contents of the pack

Bactroban is a white, translucent ointment.
Bactroban is available in a 15 g tube. Each tube is contained in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via Alessandro Fleming, 2 - Verona
Manufacturer
Glaxo Wellcome Operations - Harmire Road - Barnard Castle – United Kingdom
Other sources of information
More detailed information on this medicinal product is available on the AIFA website