Patient information leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bactroban, 20 mg/g, nasal ointment
Mupirocin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Leaflet contents

What Bactroban is and what it is used for
What you need to know 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 micronized calcium mupirocinate.
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 the medicines you are currently taking or
have recently taken, including those obtained without a prescription, herbal medicines, and any medicines you plan to take.
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Pregnancy and breastfeeding
If you are pregnant or 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 exactly as recommended by a doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How to use the medicine
Apply Bactroban into the nose twice daily.

Wash and dry your hands.
Squeeze a small amount of ointment, about the size of a match head, 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 within the nostrils.
Close the tube tightly and wash your hands.

Small children and elderly patients
Instead of using the 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, 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 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 swallowed.
Missed dose of Bactroban
If the patient forgets to apply the medicine, apply it as soon as they remember. However, 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 treatment with Bactroban
If the patient stops using Bactroban too early, not all bacteria may be killed or they may continue to multiply. Consult your doctor or pharmacist about when to stop using 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 not everyone experiences them.
Below are listed the possible adverse effects of this medicine.

Uncommon (may occur in 1 in 100 to 1 in 1,000 patients):

itching, redness, burning, tingling or stinging in the nose,
nasal congestion.

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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 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 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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, 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.
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 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 package 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 ingredients are: white vaseline, softisan 649.

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What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in aluminium tubes
containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
GlaxoSmithKline Monoprosopi Α.Ε.Β.Ε.
Kifisias Ave 266
152 32 Chalandri
Greece
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., Grunwaldzka 189, 60-322 Poznań, Poland
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24,
Ireland
Parallel importer:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Numbers in Greece, the country of export: 41679/10-9-2009
50770/04-07-2013
11795/26-3-2019
Parallel import licence number: 412/19
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