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 carefully the entire leaflet 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 questions, ask 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of 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 ointment for the nose (referred to as Bactroban in this leaflet) contains an antibiotic called mupirocin, in the form of mupirocin calcium.
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 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 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 currently taken or recently taken, including those obtained without a prescription, herbal medicines, and any medicines the patient intends 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 you have any doubts,
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 fingertip.
Apply it 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 a fingertip, cosmetic 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, consult your doctor or pharmacist.
Usually, bacteria in the nose are eliminated within 3–5 days after starting treatment.
Do not use Bactroban for longer than 10 days.
Use of 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 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 killed or they may continue to multiply.
Consult your doctor or pharmacist about when to stop using the ointment.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of adverse effects that may occur with this medicine.
Uncommon (may affect 1 in 100 to 1 in 1000 patients):

itching, redness, burning, tingling or stinging in the nose;
nasal discharge (catarrh).

Very rare (may affect 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 without delay.
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 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 these symptoms occur, contact your doctor as quickly as possible.

Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Bactroban contains

The active substance is mupirocin in the form of mupirocin calcium. Each gram of nasal ointment contains 20 mg of mupirocin.
The other ingredients are: white soft paraffin, softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in tubes 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 Greece, country of export:
GlaxoSmithKline S.A.
266 Kifissias Ave
Halandri, 15 232 Athens, Greece
Manufacturer:
Glaxo Operations UK LTD
Barnard Castle, United Kingdom
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 authorization number in Greece, country of export: 50770/4-7-2013
41679/10-9-2009
Parallel import authorization number: 368/17