Bactroban

Patient Information Leaflet

Bactroban, 20 mg/g, cream
Mupirocin
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Bactroban is and what it is used for
2. What you need to know before using 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 cream contains an antibiotic called mupirocin, in the form of micronized calcium mupirocin.
It is used:

• for the treatment of skin infections such as small lacerations, sutured wounds, or abrasions caused by bacteria known as Staphylococcus aureus or Streptococcus pyogenes.

This cream is for topical use only.
Treatment should not exceed 10 days.
If there is no improvement or if your condition worsens, consult your doctor.

2. Important information before using Bactroban

When not to use Bactroban

• if the patient is allergic to mupirocin or to any of the other ingredients of Bactroban (listed in section 6).
• in patients under one year of age.

If in doubt about the use of this medicine, consult a doctor, pharmacist, or nurse.
Warnings and precautions
Before starting to use Bactroban, discuss it with your doctor, pharmacist, or nurse.
Bactroban cream should always be used as directed by the doctor. Do not apply Bactroban to the eyes or inside the nose. If the patient is applying Bactroban cream to the facial skin, care should be taken to avoid contact with the eyes, nose, or areas nearby. If the cream gets into the eye, thoroughly rinse it with water until all traces of the cream are removed.
Do not apply Bactroban inside the mouth or swallow it.
A special formulation, Bactroban nasal ointment, is available for use in the nose.
Bactroban and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
If treatment involves a cracked nipple, it should be thoroughly washed before breastfeeding.
Bactroban contains cetyl alcohol, stearyl alcohol, and benzyl alcohol.
Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Benzyl alcohol may cause mild local irritation or allergic reactions. See also section 4.

3. How to use Bactroban

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor, pharmacist, or nurse.
How to use the medicine
Do not apply other ointments or creams to the area where Bactroban is used, as this may
reduce its effectiveness.
Bactroban is usually applied to the skin up to 3 times daily.

1. Wash and dry your hands.
2. Apply a small amount of cream onto a piece of clean cotton wool or gauze.
3. Use this to apply the cream to the affected area of skin.
4. The treated area may be covered with a dressing if necessary, unless your doctor advises leaving the area uncovered.
5. Recap the tube and wash your hands.

How long to use Bactroban
Use Bactroban for as long as directed by your doctor. If in doubt, consult your doctor,
pharmacist, or nurse. Bacteria are usually eliminated after 10 days of treatment.
Do not use Bactroban for longer than 10 days.
If there is no improvement within 3 to 5 days of starting treatment, consult your doctor.
Prolonged use of Bactroban may lead to fungal (yeast) infection in areas of the body with high moisture.
These appear as bright red patches on the skin, which may be very itchy. Sometimes small pustules may be present in the center.
If such symptoms occur, inform your doctor or pharmacist.
Use in children
Do not use in children under one year of age, as adequate studies have not been conducted.
Use of more than the recommended dose of Bactroban
If more than the recommended amount of Bactroban is used, contact your doctor,
pharmacist, or nurse. Carefully remove any excess cream.
If Bactroban is swallowed, contact your doctor immediately and inform them what and how much has been swallowed.
Missed dose of Bactroban
If the patient forgets to apply the medicine, apply it as soon as they remember. If the next dose is due within one hour,
skip the missed dose.
Do not apply a double dose to make up for a missed dose.
Stopping Bactroban treatment
If the patient stops using Bactroban too early, not all bacteria may be killed or they may continue to multiply.
Ask your doctor, pharmacist, or nurse when to stop using the cream.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Symptoms to be aware of
Generalised allergic reactions
These occur very rarely (may occur in fewer than 1 in 10,000 patients). Symptoms include:

• generalised rash, urticaria,
• angioedema (swelling, sometimes affecting the face and lips, which may lead to breathing difficulties),
• fainting or loss of consciousness. If such symptoms occur, stop using the medicine immediately and contact a doctor at once.

If skin irritation or hypersensitivity occurs in the patient, you should:

• remove the cream,
• discontinue use of the medicine,
• inform the doctor as quickly as possible.

In rare cases, medicines such as Bactroban cream may cause inflammation of the colon
(large intestine) – this is characterised by diarrhoea, usually bloody and containing mucus, abdominal
pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact a doctor as quickly as possible.

The adverse effects of this medicine listed below may also occur.
Common (may affect fewer than 1 in 10 patients):

• skin allergic reactions at the site of application including: itching, redness, burning sensation, urticaria, contact dermatitis, rash.

Redness and dryness of the skin may also occur in areas other than the treated area.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bactroban

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the container following "EXP".
The expiry date refers to the last day of the stated month.
"Lot" is the product batch number.
Do not use Bactroban if it looks different from normal (see description in section 6).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bactroban contains

• The active substance is mupirocin in the form of mupirocin calcium. Each gram of cream contains 20 mg of mupirocin.
• The other ingredients are: xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol, purified water.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous cream. The medicine is available in aluminium tubes containing 15 g of cream, packed in a cardboard box.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Importer
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Importer
Delpharm Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

For further information, please contact the representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (0-22) 576 9000
GSK logo