BACTROBAN 20 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Bactroban, 20 mg/g, Cream
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Bactroban and what is it used for
4. Important information before using Bactroban
   1. When not to use Bactroban
   2. Warnings and precautions
   3. Bactroban and other medicines
   4. Pregnancy and breastfeeding
   5. Bactroban contains cetyl alcohol, stearyl alcohol, and benzyl alcohol.
5. How to use Bactroban
   1. Using the medicine
   2. How long to use Bactroban
   3. Using Bactroban in children
   4. Using more Bactroban than recommended
   5. Missing a dose of Bactroban
   6. Stopping Bactroban treatment
6. Possible side effects
   1. Symptoms to watch out for
   2. Generalized allergic reactions
   3. If the patient experiences skin irritation or hypersensitivity, they should
   4. Reporting side effects
7. How to store Bactroban
8. Contents of the pack and other information
   1. What Bactroban contains
   2. What Bactroban looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. Importer

Package Leaflet: Information for the User

Bactroban, 20 mg/g, Cream

Mupirocin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Bactroban and what is it used for
• 2. Important information 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 is Bactroban and what is it used for

Bactroban cream contains the antibiotic mupirocin in the form of calcium mupirocin (micronized).
It is used:

• to treat skin infections, such as infections of small cuts, stitched wounds, or scrapes, caused by bacteria called Staphylococcus aureusor Streptococcus pyogenes.

This cream is intended for use on the skin only.
Treatment should not exceed 10 days.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Bactroban

When not to use Bactroban

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

In case of doubts about using the medicine, consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting to use Bactroban, discuss it with a doctor, pharmacist, or nurse.
Bactroban cream should always be used as directed by a doctor. Do not use Bactroban in the eyes or nose. If the patient uses Bactroban on the face, be careful not to apply it to the eyes, nose, or their vicinity. If the cream gets into an eye, rinse it thoroughly with water until the cream is removed.
Do not use Bactroban in the mouth or swallow it.
A special form is available for use in the nose: Bactroban, nasal ointment.

Bactroban and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before using this medicine.
In the case of cracked nipple treatment, wash the nipple very thoroughly 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 as directed by a doctor or pharmacist. In case of doubts, consult a doctor, pharmacist, or nurse.

Using the medicine

Do not apply other ointments or creams to the area where Bactroban is applied, as this may reduce its effectiveness.
Bactroban cream is usually applied to the skin up to 3 times a day.

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

How long to use Bactroban

Bactroban should be used for as long as the doctor recommends. In case of doubts, consult the doctor, pharmacist, or nurse. Bacteria usually die within 10 daysof starting treatment.
Do not use Bactroban for more than 10 days.
If there is no improvement within 3 to 5 days of treatment, consult the doctor.
If Bactroban is used for a longer period, a fungal infection may occur in areas of the body with high moisture. On the skin, there are light red spots that can be very itchy. Sometimes, small pimples may appear in the center.
If such symptoms occur, inform the doctor or pharmacist.

Using Bactroban in children

Do not use in children under one year of age, as no adequate studies have been conducted.

Using more Bactroban than recommended

In case of using more Bactroban than recommended, consult a doctor, pharmacist, or nurse. Carefully remove excess cream.
If Bactroban is swallowed, immediately consult a doctor and inform them of what and how much was swallowed.

Missing a dose of Bactroban

If the patient forgets to use the medicine, they should use it as soon as they remember. If the next dose is due within an hour, skip the missed dose.
Do not use 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 may continue to multiply. Ask the doctor, pharmacist, or nurse when to stop using the cream.
In case of further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bactroban can cause side effects, although not everybody gets them.

Symptoms to watch out for

Generalized allergic reactions

These occur very rarely (may occur less often than in 1 in 10,000 patients). Symptoms include:

• generalized rash, urticaria,
• angioedema (swelling, sometimes also of the face and lips, which can lead to breathing difficulties),
• fainting or loss of consciousness. if such symptoms occur, stop using the medicine and contact a doctor immediately.

If the patient experiences skin irritation or hypersensitivity, they should

• remove the cream
• stop using the medicine
• inform their doctor as soon as possible

In rare cases, medicines like Bactroban cream may cause pseudomembranous colitis(inflammation of the colon) – characterized by the appearance of diarrhea, usually bloody and containing mucus, abdominal pain, fever ( pseudomembranous colitis).
In case of the above symptoms, contact a doctor as soon as possible.
The following are also side effects of this medicine that may occur.
Common(may occur less often than in 1 in 10 patients):

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

Redness and dryness of the skin may also occur on other parts of the body than the treated area.

Reporting side effects

If side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Bactroban

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging after: “EXP”.
The expiry date refers to the last day of the month.
The “Lot” abbreviation means 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 a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bactroban contains

• The active substance is mupirocin in the form of calcium mupirocin. 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 cream with a uniform consistency. The medicine is available in aluminum tubes containing 15 g of cream, in a cardboard box.

Marketing authorization 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
Irlandia

Importer

Delpharm Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Polska
To obtain more detailed information, contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (0-22) 576 9000
Date of last revision of the leaflet:January 2025
GSK logo