Bactroban

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Bactroban is and what it is 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 Bactroban is and what it is used for

Bactroban nasal ointment (referred to as Bactroban in this leaflet) contains an antibiotic
called mupirocin in the form of mupirocin calcium.
It is used:

• to eliminate from the nose bacteria belonging to a group called 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
If the patient is allergic to mupirocin or any of the other ingredients of Bactroban
(listed in section 6).
If in doubt about using the medicine, consult a doctor or pharmacist.
Warnings and precautions

• do not use in newborns and infants.
• do not apply Bactroban 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
Tell 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, breastfeeding, think 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 according to the instructions given by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
How to use the medicine
Bactroban ointment should be applied into the nose twice daily.

1. Wash and dry your hands.
2. Squeeze a small amount of ointment, about the size of a match head, onto your little finger.
3. Apply it inside one nostril.
4. Repeat steps 2 and 3 for the other nostril.
5. Press the sides of the nose together and gently squeeze to spread the ointment evenly inside the nostrils.
6. Replace the cap on the tube and wash your hands.

Small children and elderly patients
Instead of using the little finger, cosmetic swabs may be used to apply Bactroban ointment into the nose.
Special precautions should be taken in these patient groups. Bactroban must not be used in newborns and infants.
How long to use Bactroban
Continue using Bactroban for as long as your doctor has advised. If in doubt, consult your doctor or pharmacist.
Usually, bacteria in the nose are eliminated after 3–5 days of treatment.
Do not use Bactroban for longer than 10 days.
Use of a higher than recommended dose of Bactroban
If more Bactroban ointment has been used than recommended, 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 a patient forgets to apply the ointment, it should be applied as soon as remembered. However, if the time for the next dose is within one hour, skip the missed dose.
Do not apply a double dose to make up for a missed dose.
Stopping Bactroban treatment prematurely
If treatment with Bactroban is stopped too early, not all bacteria may be eliminated and they may continue to multiply.
Consult your doctor or pharmacist about when to stop using the ointment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are listed the adverse reactions that may occur with this medicine.
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 also of the face and lips, which may lead to breathing difficulties), ► fainting or loss of consciousness → if any of these symptoms occur, discontinue use of the medicine immediately and contact a doctor.

If skin irritation or hypersensitivity occurs

• remove the ointment from the skin,
• discontinue use of the medicine,
• inform the treating physician as quickly as possible.

In rare cases, medicines such as Bactroban nasal ointment may cause inflammation of the colon (large intestine) – this manifests as 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.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse reactions helps to gather additional information on the safety of using this 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 packaging. The expiry date refers to the last day of the stated month.
Do not use Bactroban if it looks different from the normal appearance (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. Such measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is mupirocin in the form of mupirocin calcium. Each gram of nasal ointment contains 20 mg of mupirocin.
• Other ingredients: white vaseline, 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 with a cap, containing 3 g of ointment, packed in a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder 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
Riverwalk, Citywest Business Campus 12 D24 YK11 Dublin 24, Ireland
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austria, country of export, Marketing Authorisation number: 1-20226
Parallel import licence number: 356/24