Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Bactroban (Bactroban nasal)
20 mg/g, nasal ointment
Mupirocin
Bactroban and Bactroban nasal are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet, so that you can read it again if necessary.
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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 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 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
If the patient is allergic to mupirocin or to any of the other ingredients of Bactroban
(listed in section 6).
If in doubt about the use of the medicine, consult a 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 eyes. If 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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
How to use the medicine
Bactroban should be applied 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 gently to spread the ointment evenly inside the nostrils.
Replace the cap on the tube and wash your hands.

Young children and elderly patients
Instead of using a fingertip, cosmetic swabs may be used to apply Bactroban into the nose.
Special precautions should be taken in these patients. Bactroban should not be used in newborns and infants.
How long to use Bactroban
Continue using Bactroban for as long as directed by your doctor. If in doubt, contact 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.
Using more than the recommended dose of Bactroban
If more Bactroban than recommended 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.
Missing a dose of Bactroban
If a dose is missed, apply it as soon as remembered. However, if it is almost time for the next dose (within one hour), skip the missed dose.
Do not use 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 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below 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 discharge (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 affecting 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 immediately.

If skin irritation or hypersensitivity occurs

remove the ointment from the skin,
stop using 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) – characterized by the onset of 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 Adverse Drug Reactions 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
Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store Bactroban

Keep the medicine out of the sight and reach of children.
Store below 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 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 in use. 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. Each gram of nasal ointment contains 20 mg of mupirocin.
The other ingredients are: white soft paraffin, softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in tubes containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
GlaxoSmithKline S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Spanish Marketing Authorisation Number (country of export): 767111.4
Parallel Import Licence Number: 125/25