Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Bactroban, 20 mg/g, nasal ointment
Mupirocin
Please read all of this leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Bactroban is and what it is used for
Important information 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 ointment for the nose (referred to as Bactroban in this leaflet) contains an antibiotic called mupirocin in the form of mupirocin calcium.
It is used:

to eliminate bacteria from the nose belonging to a group known as staphylococci. This group includes MRSA (methicillin-resistant Staphylococcus aureus strains).

This ointment is intended for nasal use only.

2. Important information before using Bactroban

When not to use Bactroban
Do not use Bactroban if you are allergic to mupirocin or to any of the other ingredients of this medicine listed in section 6.
If in doubt about using this medicine, consult your doctor or pharmacist.

Warnings and precautions

Do not use in newborns and infants.
Do not apply Bactroban ointment to the eyes or near the eyes. Avoid contact with the eyes. If the ointment gets into the eye, rinse thoroughly with water until all traces of the ointment are removed.
Do not apply Bactroban to the mouth or swallow it.

Bactroban and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal medicines, and any medicines you plan to take.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

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 or pharmacist.
How to use the medicine
Apply Bactroban ointment inside the nose twice daily.

Wash and dry your hands.
Squeeze a small amount of ointment, about the size of the tip of a matchstick, onto your fingertip.
Apply it inside one nostril.
Repeat steps 2 and 3 for the other nostril.
Press the sides of the nose together and gently squeeze to evenly distribute the ointment within the nostrils.
Recap the tube and wash your hands.

Young children and elderly patients
Instead of using a finger, cosmetic swabs may be used to apply Bactroban ointment into the nose.
Particular caution should be exercised in these patients. Bactroban should not be used in newborns or infants.
How long to use Bactroban
Continue using Bactroban for as long as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Usually, bacteria in the nose are eliminated within 3–5 days after starting treatment.
Do not use Bactroban for longer than 10 days.
Use of more than the recommended dose of Bactroban
If more than the recommended amount of Bactroban has been used, contact your doctor or pharmacist.
Carefully remove any excess ointment.
If Bactroban has been swallowed, contact your doctor immediately and inform them what and how much has been ingested.
Missed dose of Bactroban
If the patient forgets to apply the ointment, 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 or pharmacist when to stop using the ointment.
If in doubt about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below are listed the adverse effects of this medicine that may occur.
Uncommon (may occur in 1 in 100 to 1 in 1000 patients):

itching, redness, burning, tingling or stinging in the nose,
nasal congestion (catarrh).

Very rare (may occur in fewer than 1 in 10,000 patients):

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

If skin irritation or hypersensitivity occurs:

remove the ointment from the skin,
discontinue use of the medicine,
inform the doctor as quickly as possible.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Do not use Bactroban if it looks different than usual (see description in section 6).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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. 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, homogeneous ointment. The medicine is supplied in an aluminium tube containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
GlaxoSmithKline Pharma GmbH
Wienerbergstraße 7, 1100 Vienna, Austria
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, D24 YK 11, Dublin 24, Ireland
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Austria, the country of export: 1-20226
Parallel Import Authorisation Number: 134/24