Bactroban

Package Leaflet: Information for the User

Bactroban, 20 mg/g, Ointment

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. 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 ointment contains the antibiotic mupirocin. It is used for:

• local treatment of primary and secondary bacterial skin infections caused by mupirocin-sensitive strains of Staphylococcus aureus, including methicillin-resistant strains, and Streptococcus pyogenes.
• treatment of skin infections such as:
• impetigo (infectious skin disease causing a painless, red rash with numerous pus-filled blisters),
• folliculitis (infection of the hair follicles),
• furunculosis (recurring boils),
• in the course of various dermatoses (skin diseases),
• for the prevention of infections of traumatic skin lesions, such as small lacerations, sutured wounds, and abrasions.

This ointment is intended for use on the skin only.

2. Important information before using Bactroban

When not to use Bactroban

If you are allergic to mupirocin, polyethylene glycol (listed in section 6 as macrogol) or any of the other ingredients of this medicine (listed in section 6).
In case of doubts about the use of the medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Bactroban, discuss it with your doctor or pharmacist.
Since Bactroban contains polyethylene glycol, consult a doctor or pharmacist before using the medicine if:

• you have kidney problems, open wounds, or skin damage that requires treatment of large areas of the body. If an allergic reaction or severe local irritation occurs, discontinue treatment, wash the product off the skin, and consult a doctor or pharmacist.

If Bactroban is used on the face, avoid contact with the eyes. Do not
use Bactroban in the nose, eyes, at the site of a venflon, or at the site of central venous catheterization.
If you use Bactroban on the face, be careful not to apply it to the eyes or nose or their vicinity.
If the ointment gets into an eye, rinse it thoroughly with water until the ointment is removed.
Do not introduce the medicine into the mouth or swallow it.
A special form is available for use in the nose: Bactroban nasal ointment.
Do not use Bactroban for more than 10 days.

Bactroban and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your 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 polyethylene glycol (macrogol)(see "Warnings and precautions").

3. How to use Bactroban

Always use this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.

Using the medicine

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

• 1. Wash and dry your hands.
• 2. Apply a small amount of ointment to a piece of clean cotton wool or gauze.
• 3. Use this to apply the ointment to the affected area of skin.
• 4. The treated area can be covered with a dressing if necessary, unless your doctor has told you to leave it uncovered.
• 5. Replace the cap on the tube and wash your hands.

How long to use Bactroban

Use Bactroban for as long as your doctor tells you to. If you are unsure, talk to your doctor or pharmacist. Bacteria are usually killed within 10 days of starting treatment.
Do not use Bactroban for more than 10 days.

Using more Bactroban than you should

If you use more Bactroban than you should, talk to a doctor or pharmacist. Carefully remove any excess ointment.
If you swallow any Bactroban, talk to a doctor immediately and tell them how much you think you have swallowed.

Forgetting to use Bactroban

If you forget to use Bactroban, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.

Stopping using Bactroban

If you stop using Bactroban too soon, not all the bacteria may be killed or they may start to grow again. Ask your doctor when to stop using the ointment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bactroban can cause side effects, although not everybody gets them.
The following side effects may occur with Bactroban:

• burning sensation at the application site.

Uncommon(may affect up to 1 in 100 people):

• itching, redness, stinging, and dryness at the application site.
• allergic rash (hypersensitivity), itching, redness, or skin pain may also affect other parts of the body.

Rare(may affect up to 1 in 1,000 people):
Systemic allergic reactions such as:

• generalized rash, hives,
• angioedema (swelling, sometimes also of the face and lips, which may lead to difficulty breathing),
• fainting or loss of consciousness,

and contact a doctor immediately.

If you get skin irritation or hypersensitivity

• remove the ointment from the skin
• stop using the medicine
• tell your doctor as soon as possible

In rare cases, medicines like Bactroban ointment may cause colitis (inflammation of the colon) – characterized by the onset of diarrhea, usually bloody and containing mucus, abdominal pain, fever (pseudomembranous colitis).
If you get any of these symptoms, contact a doctor as soon as possible.

Reporting 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 directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocides, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bactroban

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP".
The "Lot" abbreviation means the batch number of the product.
Do not use Bactroban if it looks different from normal (see description in point 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. Contents of the pack and other information

What Bactroban contains

• The active substance is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
• The other ingredients are: macrogol 400, macrogol 3350.

What Bactroban looks like and contents of the pack

Bactroban is a semi-transparent ointment with a white color and uniform consistency. The medicine is available in aluminum tubes containing 15 g of ointment, 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
Ireland

Importer

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