Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Bactroban, 20 mg/g (2%) nasal ointment
Mupirocin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
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. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell 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 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
Do not use this medicine if you are allergic to mupirocin or to any of the other ingredients of Bactroban (listed in section 6).
If you are unsure about using this medicine, consult your 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 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 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, 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 ointment should be applied inside the nostrils 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 and gently squeeze to evenly spread the ointment within the nostrils.
Recap the tube and wash your hands.

Small children and elderly patients
Instead of using the fingertip, cosmetic swabs may be used to apply the ointment into the nose.
Particular caution should be exercised 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 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 has been used than recommended, contact your doctor or pharmacist. Carefully remove any excess ointment.
In case of accidental ingestion of Bactroban, 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. 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 Bactroban treatment
If Bactroban treatment is stopped too early, not all bacteria may be eliminated or they may continue to multiply. Consult your doctor or pharmacist about when to stop using the ointment.
If in doubt about the use of 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.
Below are listed the adverse reactions that 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, potentially leading to breathing difficulties),
fainting or loss of consciousness. If any of these symptoms occur, stop using 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 doctor 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 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 provide more information on the safety of 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. 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 packaging and other information

What the medicine Bactroban contains

The active substance is mupirocin in the form of mupirocin calcium. Each gram of nasal ointment contains 20 mg of mupirocin.
Other ingredients: white soft paraffin, glycerol esters of fatty acids (Softisan 649).

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in a tube with a cap, containing 3 g of ointment, packed in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, the country of export:
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Site Apollo
Avenue Pascal, 2-4-6
B-1300 Wavre, Belgium
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24, Ireland
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Belgium, the country of export: BE159801
Parallel Import Authorisation Number: 46/24