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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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. It is used:

• to eliminate bacteria from the nose, including a group of bacteria known as staphylococci, including 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 the patient is 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 medicine, 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 medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including those that are available without a prescription and herbal medicines, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

3. How to use Bactroban

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Using the medicine

Bactroban should be applied twice a day to the nose.

• 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. Place it inside one nostril.
• 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 medicine to the nose, you can use cotton swabs. In these patients, special precautions should be taken. 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. Normally, 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 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.

Missing a dose of Bactroban

If you forget to use your medicine, use 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 early, not all the 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 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 are side effects of Bactroban that 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 also of the face and lips, which can lead to difficulty breathing),
• fainting or loss of consciousness .

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, 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. You can also report side effects 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, tel.: +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. Store in a temperature 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 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. 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 of uniform consistency. The medicine is available in a 3g aluminum tube with a plastic screw cap, in a cardboard box. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the 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:

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, Marketing authorization number in Bulgaria, the country of export:20010150

Parallel import authorization number: 316/24

Date of leaflet approval: 01.08.2024

[Information about the trademark]