Bactroban

PACKAGE LEAFLET: INFORMATION FOR THE USER

WARNING! Keep this leaflet, 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, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Bactroban is and what it is 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 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 from the nose bacteria belonging to a group known as staphylococci. 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 this medicine
Bactroban (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 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 with 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 baby, she should consult her 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 a doctor or pharmacist.
How to use the medicine
Bactroban medicine should be applied 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 your little finger.
3. Apply inside one nostril.
4. Repeat steps 2 and 3 for the other nostril.
5. Press the sides of the nose together and gently squeeze to evenly spread the ointment within the nostrils.
6. Close the tube by screwing the cap back on and wash your hands.

Small 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 medicine for longer than 10 days.
Using more than the recommended dose of Bactroban medicine
If more than the recommended dose of Bactroban 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 has been swallowed.
Missing a dose of Bactroban medicine
If the patient forgets to use the medicine, it should be applied as soon as they remember. If the next dose is due within one hour, skip the missed dose.
Do not use 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Below are listed the side effects of this medicine that may occur.
Uncommon (may affect 1 in 100 to 1 in 1000 patients):

• itching, redness, burning, tingling or stinging in the nose,
• nasal discharge (catarrh).

Very rare (may affect 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 of 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 and contact your doctor immediately. If the patient experiences skin irritation or hypersensitivity:
• remove the ointment from the skin,
• discontinue use of the medicine,
• inform your doctor as soon as possible.

In rare cases, medicines such as Bactroban nasal ointment may cause inflammation of the colon (large intestine) – this is 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 your doctor as quickly as possible.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Bactroban

Keep this medicine 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 stated month.
Do not use Bactroban if it looks different from the normal appearance (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. These measures help protect the environment.
Translation of some information on the immediate packaging:
LOTE - batch number
CAD - expiry date

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.
• Other ingredients: white vaseline, softisan 649.

What Bactroban looks like and contents of the pack
Bactroban is a white, homogeneous ointment. The medicine is available in aluminum tubes containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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., Grunwaldzka 189, 60-322 Poznan, Poland
Parallel importer:
PharmaVitae Sp. z o.o. sp. k., E. Orzeszkowej 3/35, 59-820 Lesna
Repackaged in:
Pharma Innovations Sp. z o.o., Jagiellonska 76, 03-301 Warsaw
LABOR Pharmaceutical and Chemical Enterprise Sp. z o.o., Długosza 49, 51-162 Wroclaw
Medezin Sp. z o.o., Zbąszyńska 3, 91-342 Lodz
CANPOLAND JOINT STOCK COMPANY, Beskidzka 190, 91-610 Lodz
SHIRAZ PRODUCTIONS Sp. z o.o., Tymiankowa 24/28, 95-054 Ksawerow
Marketing authorisation number in Spain, the country of export: 767111.4
Parallel import authorisation number: 289/17