Bactroban

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

ATTENTION! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Bactroban (Bactroban Nasal), 20 mg/g, nasal ointment

Mupirocin
Bactroban Bactroban Nasalare 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 you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. Contents of the package and other information

1. What is Bactroban and what is it used for

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

• to eliminate bacteria from the nose, including a group of bacteria known as staphylococci, including 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 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 a 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 a doctor or pharmacist.

Using the medicine

Bactroban should be applied to the nose 2 times a day.

• 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 using the little finger to apply the medicine to the nose, you can use a cotton swab.
Special precautions should be taken with these patients. 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 consult 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 Bactroban than recommended

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

Missing a dose of Bactroban

If you forget to use Bactroban, you should use it as soon as you remember. If it is almost time for your next dose, you should skip the missed dose.
You should not use a double dose to make up for a missed dose.

Stopping Bactroban treatment

If you stop using Bactroban too early, not all the bacteria may be killed or they 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, Bactroban 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.

Rare(may affect up to 1 in 1,000 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 or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help provide more information on the safety of this 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 Bactroban after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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.

Translation of some information on the immediate packaging:

LOT - batch number
EXP - expiry date

6. Contents of the package 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.
• Other ingredients: 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 aluminum tubes containing 3 g of ointment, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

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

Manufacturer:

GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznań, Poland

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Spanish authorization number, country of export:767111.4
Parallel import authorization number:289/17
Date of leaflet approval: 29.08.2022
[Information about the trademark]