Bactroban

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bactroban (Bactroban 2%), 20 mg/g, nasal ointment

Mupirocin
Bactroban and Bactroban 2% are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Bactroban and what is it used for
• 2. Important information before using Bactroban
• 3. How to use Bactroban
• 4. Possible side effects
• 5. How to store Bactroban
• 6. Package contents and other information

1. What is Bactroban and what is it used for

Bactroban nasal ointment (referred to as Bactroban in this leaflet) contains the antibiotic
called mupirocin in the form of calcium mupirocin.
It is used:

• to eliminate bacteria from the nose, including the group called staphylococci. This group includes MRSA (methicillin-resistant Staphylococcus aureus).

This ointment is intended for use in the nose 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).
In case of doubts related to the use of the medicine, the doctor or pharmacist should be consulted.

Warnings and precautions

• do not use in newborns and infants.
• do not use Bactroban in the eyes or near the eyes. Avoid eye contact.If the ointment gets into the eye, it should be rinsed thoroughly with water until the ointment is removed.
• do not use Bactroban in the mouth or swallow it.

Bactroban and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or
recently taken, including those that are available without a prescription and herbal medicines, as well as medicines that the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

3. How to use Bactroban

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts,
the doctor or pharmacist should be consulted.

Using the medicine

Bactroban should be introduced into the nose 2 times a day.

• 1. Wash and dry hands.
• 2. A small amount of ointment, the size of a match head, should be squeezed onto a small finger.
• 3. Place it inside one of the nostrils.
• 4. Repeat steps 2 and 3 for the other nostril.
• 5. Squeeze the nostrils to distribute the ointment evenly.
• 6. Close the tube and wash hands.

Small children and the elderly

Instead of a small finger to introduce the medicine into the nose, cosmetic sticks can be used.
Special precautions should be taken in these patients. Bactroban should not be used in newborns and infants.

How long to use Bactroban

Bactroban should be used for as long as the doctor recommends. In case of doubts,
the doctor or pharmacist should be consulted. Usually, the bacteria in the nose die
after 3-5 days of treatment.
Bactroban should not be used for more than 10 days.

Using more than the recommended dose of Bactroban

In case of using more than the recommended dose of Bactroban, the doctor or pharmacist should be consulted. Excess ointment should be carefully removed.
If Bactroban is swallowed, the doctor should be consulted immediately, informing them of what and how much was swallowed.

Missing a dose of Bactroban

If the patient forgets to use the medicine, they should use it as soon as they remember. If the time for the next dose is within an hour, the missed dose should be skipped.
A double dose should not be used to make up for a missed dose.

Stopping the use of Bactroban

If the patient stops using Bactroban too early, not all bacteria may be killed
or may continue to multiply. The doctor or pharmacist should be asked when to stop using the ointment.
In case of doubts related to the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• itching, redness, burning, tingling, or stinging in the nose,
• runny nose.

Uncommon(may affect up to 1 in 100 people):

• skin hypersensitivity reactions (rash, itching, redness, pain),
• systemic allergic reactions, such as:
• generalized rash, hives,
• angioedema (swelling, sometimes also of the face and lips, which can lead to difficulty breathing),
• fainting or loss of consciousness → if such symptoms occur, the medicine should be stopped immediately and the doctor consulted.

If the patient experiences skin irritation or hypersensitivity

• remove the ointment from the skin,
• stop using the medicine,
• inform the doctor as soon as possible.

In rare cases, medicines like Bactroban nasal ointment may cause colitis (inflammation of the colon) - characterized by the appearance of diarrhea, usually bloody and containing mucus, abdominal pain, fever ( pseudomembranous colitis).
If such symptoms occur, the doctor should be consulted as soon as possible.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Bactroban

The medicine should be stored 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 month.
Do not use Bactroban if it looks different from normal (see description in point 6).
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Bactroban contains

• The active substance is mupirocin in the form of calcium mupirocin. Each gram of nasal ointment contains 20 mg (2%) of mupirocin. A 3g tube contains 60 mg of mupirocin.
• The other ingredients are: petroleum jelly, Softisan 649.

What Bactroban looks like and what the package contains

Bactroban is a white ointment with a uniform consistency. The medicine is available in aluminum tubes containing 3g of ointment, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in France, the country of export:

Laboratoire GlaxoSmithKline, 23, rue François Jacob, 92500 Rueil-Malmaison, France

Manufacturer:

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24,
Ireland
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
French marketing authorization number, country of export: 34009 363 416 5 4
34009 363 417 1 5

Parallel import authorization number: 101/23

Date of leaflet approval: 05.06.2023

[Information about the trademark]