Bactroban

Package Leaflet: Information for the User

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bactroban, 20 mg/g, nasal ointment

Mupirocin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack 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 mupirocin in the form of mupirocin calcium (micronized). It is used to:

• eliminate bacteria from the nose, including MRSA (methicillin-resistant Staphylococcus aureus) strains.

This ointment is for use in the nose only.

2. Important information before using Bactroban

When not to use Bactroban

If you are allergic to mupirocin or any of the other ingredients of Bactroban (listed in section 6). If you are unsure about using the medicine, consult your 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 an eye, rinse it thoroughly with water to remove the ointment.
• Do not use Bactroban in the mouth or swallow it.

Bactroban and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription and herbal medicines, as well as any 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, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Bactroban

Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Using the medicine

Use Bactroban twice a dayin the nose.

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

Small children and the elderly

Instead of using a little finger to apply the ointment, a cotton swab can be used. Special care should be taken with these patients. Bactroban should not be used in newborns and infants.

How long to use Bactroban

Use Bactroban for as long as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The bacteria in the nose usually die after 3-5 days of treatment. Do not use Bactroban for more than 10 days.

Using more Bactroban than you should

If you use more Bactroban than you should, consult your doctor or pharmacist. Carefully remove any excess ointment. If you swallow Bactroban, contact your doctor immediately and tell them how much you have taken.

Forgetting to use Bactroban

If you forget to use your medicine, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

Stopping Bactroban treatment

If you stop using Bactroban too soon, the bacteria may not be fully eliminated or may continue to multiply. Ask your doctor or pharmacist when to stop using the ointment. If you are unsure about using the medicine, consult your 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:

Uncommon(may affect up to 1 in 100 people):

• itching, redness, burning, tingling, or prickling sensation 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 of the face and lips, which may lead to difficulty breathing),
• fainting or loss of consciousness → if you experience any of these symptoms, stop using the medicine immediately and contact your doctor.

If you experience skin irritation or hypersensitivity

• remove the ointment from the skin,
• stop using the medicine,
• tell your doctor as soon as possible.

In rare cases, medicines like Bactroban nasal ointment may cause colitis (inflammation of the colon) – characterized by the onset of diarrhea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis). If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Keep the tube tightly closed. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bactroban contains

The active substance is mupirocin in the form of mupirocin calcium (micronized). Each gram of nasal ointment contains 20 mg of mupirocin. The other ingredients are white petrolatum, softisan 649.

What Bactroban looks like and contents of the pack

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, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Beecham Portuguesa – Produtos Farmacêuticos e Químicos, Lda. Rua Dr. António Loureiro Borges, 3 Arquiparque, Miraflores 1495-131 Algés Portugal

Manufacturer:

Glaxo Operations UK Limited Harmire Road, Barnard Castle DL12 8DT Durham United Kingdom GlaxoSmithKline Pharmaceuticals S.A. 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 by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Authorization number in Portugal, the country of export: 8707729 8707737

Parallel import authorization number: 73/17 Date of approval of the leaflet: 01.03.2022

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