Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Bactroban (Bactroban 2 %)
20 mg/g, nasal ointment
Mupirocin
Bactroban and Bactroban 2 % are different trade names for the same medicinal product.
Please read this 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 further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

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
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 in 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 with 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, 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 your 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 little finger.
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.

Small children and elderly patients
Instead of using the little finger, cosmetic cotton swabs may be used to apply the ointment 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.
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 swallowed.
Missed dose of Bactroban
If the patient forgets to apply the ointment, it should be applied as soon as remembered. 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 the use of Bactroban
If the patient stops using Bactroban too early, not all bacteria may be eliminated or they may continue to multiply.
Consult your doctor or pharmacist before stopping the ointment.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Below are listed the adverse effects that may occur with this medicine.
Uncommon (may occur in 1 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 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) – this may manifest as diarrhoea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact your 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, tel.: +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 the medicine out of the 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 normal (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. 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. A 3 g tube contains 60 mg of mupirocin.
The other ingredients are: vaseline, Softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in an aluminum tube containing 3 g of ointment, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, the country of export:
Laboratoire GlaxoSmithKline
23, rue François Jacob
92500 Rueil-Malmaison
France
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24
Ireland
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznań
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in France, the country of export: 3400936341654
363416-5
Parallel Import Marketing Authorisation number: 376/22