Package leaflet: Information for the user

Warning! Keep this 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 medicine.
Please read this leaflet carefully before using the 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 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.

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 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
If the patient is allergic to mupirocin or to any of the other ingredients of the medicine
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
Inform your doctor or pharmacist about all medicines currently taken or
recently used, including those obtained without a prescription, herbal medicines, and any medicines the patient plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 ointment should be applied inside the nose twice daily.

Wash and dry your hands.
Squeeze a small amount of ointment, about the size of a match head, onto the 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 within the nostrils.
Replace the cap on the tube and wash your hands.

Small children and elderly patients
Instead of using the fingertip, cosmetic swabs may be used to apply Bactroban ointment into the nose.
Special precautions should be taken in these patients. Bactroban must 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, consult your doctor or pharmacist.
Usually, bacteria in the nose are eliminated within 3–5 days of starting treatment.
Do not use Bactroban for longer than 10 days.
Use of 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 swallowed.
Missed dose of Bactroban
If a patient forgets to apply the ointment, they should 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 a patient stops using Bactroban too early, not all bacteria may be killed and 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 a 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 possible adverse reactions associated 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, stop using the medicine immediately and contact your doctor without delay.

If skin irritation or hypersensitivity occurs:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Bactroban

Keep this medicine out of sight and reach of children.
Store below 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 month indicated.
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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bactroban contains

The active substance is mupirocin as mupirocin calcium. Each gram of nasal ointment contains 20 mg of mupirocin.
The other components are: white soft paraffin, Softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a nasal ointment of white colour and uniform consistency. The medicine is available in tubes containing 3 g of ointment, packed in a cardboard carton.
For further information, please contact the Marketing Authorisation Holder 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Marketing Authorisation number in Spain, the country of export: 767111.4
Parallel import licence number: 4/25