Patient Information Leaflet

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 doubts, 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 ointment for nasal use (referred to in this leaflet as Bactroban) 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 Bactroban if you are allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6).
If you have any doubts about using this medicine, consult your 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 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, 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 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 your little finger.
Insert into 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.
If more Bactroban than recommended is used
If more Bactroban than recommended has been used, contact your doctor or pharmacist. Carefully remove any excess ointment.
If Bactroban is swallowed, contact your doctor immediately and inform them what and how much was swallowed.
If a dose of Bactroban is missed
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, the missed dose should be skipped.
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Bactroban
If treatment with Bactroban is stopped 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 you have any doubts about how to use 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, which may lead to breathing difficulties),
fainting or loss of consciousness. If any of these symptoms occur, stop using the medicine immediately 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 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 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, phone: +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 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 container. The expiry date refers to the last day of the stated month.
Do not use Bactroban if it looks different than usual (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 helps protect the environment.

6. Contents of the packaging 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, acyloglycerols.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in an aluminium tube containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in the Czech Republic, country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, Ireland
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:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Authorisation number in the Czech Republic, country of export: 69-384/95-C
Parallel import authorisation number: 323/19