Bactroban

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is 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.
Please read this 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Bactroban is and what it is used for
2. What you need to know before using Bactroban
3. How to use Bactroban
4. Possible side effects
5. How to store Bactroban
6. Contents of the pack and other information

1. What Bactroban is and what it is used for

Bactroban nasal ointment contains an antibiotic called mupirocin (as mupirocin calcium).
It is used:

• to eliminate bacteria called staphylococci from the nose. 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
Do not use Bactroban if the patient is allergic to mupirocin or to any of the other ingredients of this medicine (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
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal medicines, and any medicines you plan to take.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

3. How to use Bactroban medicine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
How to use the medicine
Apply Bactroban medicine into the nose twice daily.

1. Wash and dry your hands.
2. Squeeze a small amount of ointment, about the size of a match head, onto the little finger.
3. Apply it inside one nostril.
4. Repeat steps 2 and 3 for the other nostril.
5. Press the sides of the nose together gently to spread the ointment evenly inside the nostrils.
6. Replace the cap on the tube and wash your hands.

Young children and elderly patients
Instead of using the little finger, cosmetic cotton swabs may be used to apply the medicine 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 medicine
Continue using Bactroban as long as directed by your doctor. If in doubt, contact 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 a higher than 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 was ingested.
Missed dose of Bactroban
If a dose is missed, apply the medicine as soon as remembered. If it is almost time for the next dose (within one hour), skip the missed dose.
Do not apply a double dose to make up for a missed dose.
Stopping the use of Bactroban
If treatment with Bactroban is stopped too early, not all bacteria may be killed and they may continue to multiply. Consult your doctor or pharmacist about when to stop using the ointment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are listed the adverse reactions associated with this medicine that may occur.
Uncommon (may occur in 1 in 100 to 1 in 1000 patients):

• itching, redness, burning, tingling or stinging in the nose
• cold-like symptoms

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 a doctor without delay

If skin irritation or hypersensitivity occurs

• remove the ointment from the skin
• discontinue use of the medicine
• inform the doctor as quickly as possible

In rare cases, medicines such as Bactroban ointment for the nose 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 a doctor as quickly as possible.
Reporting 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 Adverse Drug Reactions of the 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 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.
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 specified month.
Do not use Bactroban if it looks different than usual (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 required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Bactroban contains

• The active substance is mupirocin (as mupirocin calcium).

Each gram of nasal ointment contains 20 mg of mupirocin.

• The other ingredients are: white vaseline, softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a nasal ointment which is almost white in colour. The medicine is available in aluminium tubes containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Spain, the country of export: 767111.4
Parallel import authorisation number: 121/16