Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is 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, as you may need to read it again.
If you have any further questions, please ask 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 reactions, including any not listed in this leaflet, tell 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 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 medicine

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 medicine to the eyes or near the eyes. Avoid contact with eyes. If the ointment gets into the eye, rinse thoroughly with water until all traces of the ointment are removed.
Do not apply Bactroban medicine 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 into the nose twice daily.

Wash and dry your hands.
Squeeze a small amount of ointment, about the size of a match head, onto the fingertip.
Apply inside one nostril.
Repeat steps 2 and 3 for the other nostril.
Press the sides of the nose together and gently press to evenly spread the ointment within the nostrils.
Replace the cap on 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 after 3–5 days of treatment.
Do not use Bactroban for longer than 10 days.
Using more than the recommended dose of Bactroban
If more Bactroban than recommended 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 ingested.
Missed dose of Bactroban
If a dose is missed, apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Do not use a double dose to make up for a missed dose.
Stopping Bactroban treatment
If treatment with Bactroban is stopped too early, not all bacteria may be killed or they may continue to multiply.
Consult your doctor or pharmacist before stopping 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 of this medicine that may occur.
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 of 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 and contact a doctor immediately.

If skin irritation or hypersensitivity occurs

remove the ointment from the skin,
discontinue use of the medicine,
inform the 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Bactroban

Keep this medicine out of 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. This will help protect the environment.

6. Contents of the pack 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 soft paraffin, acyloglycerols (Softisan 649).

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in lacquered aluminium tubes containing 3 g of ointment, packed in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder 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
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189, 60-322 Poznań, Poland
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Czech Republic, country of export: 69/384/95-C
Parallel import authorisation number: 345/22