Package leaflet: Information for the user

Warning!
Keep this leaflet. Information on the immediate packaging in a foreign language.
Bactroban, 20 mg/g, nasal ointment
Mupirocin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with 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 nasal ointment (referred to as Bactroban in this leaflet) contains an antibiotic called mupirocin, in the form of calcium mupirocin (micronized).
It is used:

to eliminate from the nose bacteria 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. Important information before using Bactroban

When not to use Bactroban
If the patient is allergic to mupirocin or to any of the other ingredients of Bactroban
(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 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 currently used or recently used, including those obtained without a prescription, herbal medicines, and any medicines the patient plans 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 physician or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How to use the medicine
Bactroban should be applied inside the nose twice daily.

Wash and dry your hands.
Squeeze out 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.
Replace the cap on the tube and wash your hands.

Young children and elderly patients
Instead of using the fingertip, cosmetic swabs may be used to apply the medicine 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, 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 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.
If Bactroban has been swallowed, contact your doctor immediately and inform them what and how much has been ingested.
Missed dose of Bactroban
If the patient forgets to apply the medicine, 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 Bactroban treatment
If the patient stops using Bactroban 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 you have any doubts regarding 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 everybody gets 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 congestion (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 your doctor at once.

If skin irritation or hypersensitivity occurs

remove the ointment from the skin,
discontinue use of the medicine,
inform your doctor as quickly as possible.

In rare cases, medicines such as Bactroban nasal ointment may cause colitis (inflammation of the colon) –
characterized by diarrhoea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact your doctor as quickly as possible.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Bactroban

Keep the medicine out of sight and reach of children.
Do not store above 25°C. Keep the tube tightly closed.
Do not use Bactroban 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 appears 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Bactroban contains
The active substance is mupirocin in the form of mupirocin calcium (micronised).
Each gram of nasal ointment contains 20 mg of mupirocin.
Other ingredients: white soft paraffin, softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogenous 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 Portugal, country of export:
Beecham Portuguesa – Produtos Farmacêuticos e Químicos, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque, Miraflores
1495-131 Algés
Portugal

Manufacturer:
Glaxo Operations UK Limited
Harmire Road, Barnard Castle
DL12 8DT Durham
United Kingdom
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

Portugal, country of export, Marketing Authorisation Number: 8707729
Parallel Import Licence Number: 73/17