Bactroban

Package Leaflet: Information for the User

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

Bactroban, 20 mg/g (2%), Nasal Ointment

Mupirocin

Read the Leaflet Carefully Before Using the Medication, 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 medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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. Package Contents 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 calcium mupirocin.
It is used:

• to eliminate bacteria from the nose, including the group known as staphylococci, which includes 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 medication, 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, including those available without a prescription and herbal medicines, as well as any medications 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 medication.

3. How to Use Bactroban

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

Using the Medication

Apply Bactroban to the nose 2 times a day.

• 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 inside the nostrils.
• 6. Close the tube and wash your hands.

Small Children and the Elderly

Instead of using the little finger to apply the medication to the nose, you can use a cotton swab.
Special precautions 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 prescribed. 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 Prescribed

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 inform them of what and how much you have swallowed.

Missing a Dose of Bactroban

If you forget to use your medication, 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 missed 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 medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 can lead to difficulty breathing),
• fainting or loss of consciousness

If the Patient Experiences Skin Irritation or Hypersensitivity

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

In rare cases, medications 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 those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Bactroban

Keep the medication out of sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use Bactroban if it looks different from normal (see description in section 6).
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Bactroban Contains

• The active substance is mupirocin in the form of calcium mupirocin. Each gram of nasal ointment contains 20 mg of mupirocin.
• The other ingredients are white petrolatum, glycerol esters, and fatty acids (Softisan 649).

What Bactroban Looks Like and What the Package Contains

Bactroban is a white ointment with a uniform consistency. The medication is available in a tube with a screw cap, containing 3 g of ointment, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

GlaxoSmithKline Pharmaceuticals s.a./n.v.
Site Apollo
Avenue Pascal, 2-4-6
B-1300 Wavre, Belgium

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
Belgian Marketing Authorization Number:BE159801

Parallel Import Authorization Number: 46/24

Date of Leaflet Approval: 30.01.2024

[Information about the Trademark]