BACTROBAN

Package leaflet: Information for the user

Warning! Keep this leaflet, the information on the immediate packaging is in a foreign language!
Bactroban
20 mg/g (2%), nasal ointment
Mupirocin
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

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 micronized calcium mupirocin. 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. Information before using Bactroban

When not to use Bactroban
Do not use Bactroban if the patient is allergic to mupirocin or to any of the other ingredients of the medicine listed in section 6.
If in doubt about using this 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 ointment gets into the eye, rinse thoroughly with water until all traces of 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, 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 in doubt, consult your doctor or pharmacist.
How to use the medicine
Bactroban ointment should be applied inside 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. Gently press the sides of the nose together 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 cotton swabs may be used to apply the ointment into the nose.
Special caution 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 dose 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 a 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 a 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them. The adverse effects of this medicine that may occur are listed below.

Uncommon (may occur in 1 in 100 to 1 in 1000 patients):

• itching, redness, burning, tingling or stinging in the nose,
• 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 involving 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 and contact a doctor immediately.

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 colitis (inflammation of the large intestine), which is characterized by the onset of diarrhea, 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 effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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 gather further information on the safety of using 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 packaging.
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: vaseline, 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 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:
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
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
Marketing Authorisation numbers in France, the country of export:
34009 363 416 5 4
363 416-5
34009 363 417 1 5
363 417-1
Parallel Import Licence number: 220/19