Bactroban

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language

Bactroban, 20 mg/g, Nasal Ointment

Mupirocin

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any side effects occur, including those 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 Packaging 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. It is used:

• to eliminate bacteria from the nose, including the group known as staphylococci, which include 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 you are 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 medicinal product, 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, rinse it thoroughly with water until the ointment is removed.
• do not use Bactroban in the mouth or swallow it.

Bactroban and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, including those obtained without a prescription and herbal medicinal products, as well as any medicinal products you plan to take.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicinal product.

3. How to Use Bactroban

Always use this medicinal product exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Using the Medicinal Product

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 of your nostrils.
• 4. Repeat steps 2 and 3 for the other nostril.
• 5. Squeeze the nostrils together to spread the ointment evenly throughout the nostrils.
• 6. Close the tube and wash your hands.

Small Children and the Elderly

Instead of using the little finger to apply the medicinal product to the nose, you can use cotton swabs. In these patients, use special precautions. Do not use Bactroban in newborns and infants.

How Long to Use Bactroban

Use Bactroban for as long as your doctor has told you. In case of doubts, consult your doctor or pharmacist. Usually, the bacteria in the nose are killed within 3-5 days of starting treatment. Do not use Bactroban for more than 10 days.

Using More Bactroban Than Recommended

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 swallowed.

Missing a Dose of Bactroban

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

Stopping the Use of Bactroban

If you stop using Bactroban too early, not all the bacteria may be killed or they may multiply again. Ask your doctor or pharmacist when to stop using the ointment. In case of doubts related to the use of the medicinal product, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Bactroban can cause side effects, although not everybody gets them. The following side effects may occur:

• itching, redness, burning, tingling, or prickling sensation in the nose,
• runny nose.

Very Rare(may occur in less than 1 in 10,000 patients):

• 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 may lead to difficulty breathing),
• fainting or loss of consciousness .

If Skin Irritation or Hypersensitivity Occurs

• remove the ointment from the skin,
• stop using the medicinal product,
• inform your doctor as soon as possible.

In rare cases, medicinal products like Bactroban nasal ointment may cause pseudomembranous colitis (inflammation of the colon) - characterized by the onset of diarrhea, usually bloody and containing mucus, abdominal pain, 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal 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 medicinal product.

5. How to Store Bactroban

Keep the medicinal product out of the sight and reach of children. Do not store above 25°C. Do not use this medicinal product 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). Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This 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 petrolatum, Softisan 649.

What Bactroban Looks Like and Contents of the Packaging

Bactroban is a white ointment with a uniform consistency. The medicinal product is available in a 3 g aluminum tube in a cardboard box. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Austria, the Country of Export:

GlaxoSmithKline Pharma GmbH, Wienerbergstraße 7, 1100 Vienna, Austria

Manufacturer:

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, D24 YK 11, Dublin 24, Ireland

Parallel Importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw Austrian Marketing Authorization Number:1-20226

Parallel Import Authorization Number: 134/24

Date of Approval of the Leaflet: 27.03.2024

[Information about the Trademark]