Bactroban

Package Leaflet: Information for the User

Bactroban, 20 mg/g, Nasal 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.
• 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 nasal ointment (referred to as Bactroban in this leaflet) contains the antibiotic mupirocin in the form of mupirocin calcium (micronized).
It is used:

• to eliminate bacteria from the nose, including the group known as staphylococci, which includes MRSA (methicillin-resistant Staphylococcus aureus).

This ointment is intended for use in the nose only.

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

Warnings and precautions

• do not use in newborns and infants.
• do not use Bactroban in the eyes or near the eyes. Avoid eye contact. If the ointment gets into the eye, rinse it thoroughly with water until the ointment is removed.
• do not use Bactroban in the mouth or swallow it.

Bactroban and other medicines

Tell the doctor or pharmacist about all medicines being taken, including those obtained without a prescription and herbal medicines, as well as any medicines planned to be taken.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

3. How to use Bactroban

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

Using the medicine

Bactroban should be inserted into the nose 2 times a day.

• 1. Wash and dry your hands.
• 2. Squeeze a small amount of ointment, about the size of a matchhead, onto your little finger.
• 3. Place it inside one nostril.
• 4. Repeat steps 2 and 3 for the other nostril.
• 5. Squeeze the nostrils together to spread the ointment evenly inside the nostrils.
• 6. Replace the cap on the tube and wash your hands.

Small children and the elderly

Instead of using the little finger to insert the medicine into the nose, a cotton swab can be used.
Special precautions should be taken with these patients. Bactroban should not be used in newborns and infants.

How long to use Bactroban

Use Bactroban for as long as the doctor has prescribed. If in doubt, consult the doctor or pharmacist. The bacteria in the nose usually die within 3-5 days of starting treatment.
Do not use Bactroban for more than 10 days.

Using more Bactroban than prescribed

If more Bactroban than prescribed is used, consult the doctor or pharmacist. Carefully remove any excess ointment.
If Bactroban is swallowed, immediately consult the doctor and inform them what and how much has been swallowed.

Missing a dose of Bactroban

If a dose is missed, use it as soon as remembered. If the time for the next dose is 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 the bacteria may be killed or they may continue to multiply. Consult the doctor or pharmacist when to stop using the ointment.
In case of doubts about using the medicine, consult a 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:

• itching, redness, burning, tingling, or stinging in the nose,
• runny nose.

Rare(may affect up to 1 in 1,000 people):

• skin hypersensitivity reactions (rash, itching, redness, pain),
• systemic allergic reactions, such as:
• generalized rash, hives,
• angioedema (swelling, sometimes of the face and lips, which may lead to difficulty breathing),
• fainting or loss of consciousness. If such symptoms occur, stop using the medicine and contact a doctor immediately.

If skin irritation or hypersensitivity occurs

• remove the ointment from the skin
• stop using the medicine
• inform the doctor as soon as possible
• In rare cases, medicines like Bactroban nasal ointment may cause colitis (inflammation of the colon) - characterized by the appearance of diarrhea, usually bloody and containing mucus, abdominal pain, fever (pseudomembranous colitis).

If the above symptoms occur, contact a doctor as soon as possible.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 to 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 use this medicine after the expiry date stated on the packaging after “EXP”.
The abbreviation “Lot” means the batch number of the product.
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. Contents of the pack and other information

What Bactroban contains

• The active substance is mupirocin in the form of mupirocin calcium (micronized). Each gram of nasal ointment contains 20 mg of mupirocin.
• The other ingredients are: white petrolatum, softisan 649.

What Bactroban looks like and contents of the pack

Bactroban is a white ointment with a uniform consistency. The medicine is available in tubes containing 3 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
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
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