Bactroban

Leaflet attached to the packaging: information for the user

Warning! Keep the 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.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 tell 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.

• 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, you should consult a doctor or pharmacist.

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

You should tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, including those that are available without a prescription and herbal medicines, as well as any medicines you plan to take.

Pregnancy and breastfeeding

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

3. How to use Bactroban

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts,
you should consult your doctor or pharmacist.

Using the medicine

Bactroban should be applied twice a day to the nose.

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

Small children and the elderly

Instead of the little finger, you can use a cotton swab to apply the medicine to the nose. In these
patients, you should take special precautions. Bactroban should not be used in newborns and infants.

How long to use Bactroban

You should use Bactroban for as long as your doctor recommends. In case of doubts,
you should contact your doctor or pharmacist. Usually, the bacteria in the nose die after 3-5 days of treatment.
You should not use Bactroban for more than 10 days.

Using more than the recommended dose of Bactroban

In case of using more than the recommended dose of Bactroban, you should contact your doctor or pharmacist. Carefully remove any excess ointment.
If you swallow Bactroban, you should immediately contact your doctor and inform them of what and how much was swallowed.

Missing a dose of Bactroban

If you forget to use the medicine, you should use it as soon as you remember. If the time for the next dose is within an hour, you should skip the missed dose.
You should not use a double dose to make up for the missed dose.

Stopping the use of Bactroban

If you stop using Bactroban too early, not all bacteria may be killed or may continue to multiply. You should ask your doctor or pharmacist when to stop using the ointment.
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

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. In case of such symptoms, you should stop using the medicine immediately and contact your doctor.

If the patient experiences skin irritation or hypersensitivity

• remove the ointment from the skin
• stop using the medicine
• inform your 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).
In case of the above symptoms, you should contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Bactroban

The medicine should be stored out of sight and reach of children.
Store at a temperature 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 month.
Do not use Bactroban if it looks different from normal (see description in section 6).
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 of mupirocin.
• The other ingredients are: white petrolatum, 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 tubes containing 3 g of ointment, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export

GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain

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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Spanish marketing authorization number: 767111.4

Parallel import authorization number: 4/25

Date of leaflet approval: 10.01.2025

[Information about the trademark]
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń