Bactroban

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Bactroban
20 mg/g (2%) nasal ointment
Mupirocin
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Leaflet 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 (referred to as Bactroban in this leaflet) contains an antibiotic called mupirocin, in the form of micronized calcium mupirocin.
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
If the patient is allergic to mupirocin or to any of the other ingredients of Bactroban
(listed in section 6).
If in doubt about the use of 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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

3. How to use Bactroban medicine

This medicine should always be used according to the recommendations of a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
How to use the medicine
Bactroban medicine should be applied inside 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. Insert into one nostril.
4. Repeat steps 2 and 3 for the other nostril.
5. Press the sides of the nose gently to spread the ointment evenly inside the nostrils.
6. Close the tube tightly and wash your hands.

Small children and elderly patients
Instead of using the little finger, cosmetic 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 medicine for 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 medicine for longer than 10 days.
Use of a higher than recommended dose of Bactroban medicine
If more than the recommended dose of Bactroban medicine is used, contact your doctor or pharmacist. Carefully remove any excess ointment.
If Bactroban medicine is swallowed, contact your doctor immediately and inform them what and how much was swallowed.
Missed dose of Bactroban medicine
If the patient forgets to apply the medicine, it should be applied as soon as remembered. 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 the use of Bactroban medicine
If the patient stops using Bactroban too early, not all bacteria may be killed or they may continue to multiply. Ask your doctor or pharmacist when to stop using the ointment.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Below are listed the adverse reactions of 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,
• nasal congestion (catarrh).

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, potentially leading to breathing difficulties),
• fainting or loss of consciousness.
• If any of these symptoms occur, stop using the medicine immediately and contact a doctor at once.

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 nasal ointment may cause colitis (inflammation of the large intestine) – characterized by the onset of diarrhoea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact a doctor as quickly as possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Bactroban

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Do not use Bactroban if it looks different than 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 required. Such measures 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 vaseline, 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 Bulgaria, country of export:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing Authorization number in Bulgaria , country of export: 20010150
Parallel import authorization number: 122/25