Bactroban

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bactroban, 20 mg/g, ointment

Mupirocin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 ointment contains the antibiotic mupirocin. It is used for:

• local treatment of primary and secondary bacterial skin infections caused by mupirocin-sensitive (active substance) strains of Staphylococcus aureus, including methicillin-resistant strains, and Streptococcus pyogenes.
• treatment of skin infections such as:
• impetigo (infectious skin disease causing a painless, red rash with numerous pus-filled blisters),
• folliculitis (infection of the hair follicles),
• furunculosis (recurring boils),
• in the course of various dermatoses (skin diseases),
• for the prevention of infections of traumatic skin lesions, such as small lacerations, sutured wounds, and skin abrasions.

This ointment is intended for use on the skin only.

2. Important information before using Bactroban

When not to use Bactroban

If the patient is allergic to mupirocin, polyethylene glycol (listed in section 6 of this leaflet as macrogol) or any of the other ingredients of this medicine (listed in section 6).
In case of doubts about the use of the medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Bactroban, discuss it with your doctor or pharmacist.
Since Bactroban contains polyethylene glycol, consult your doctor or pharmacist before using the medicine if:

• the patient has kidney problems, open wounds, or skin damage that requires treatment of large body surfaces. If an allergic reaction or severe local irritation occurs, discontinue treatment, wash the medicine off the skin, and consult a doctor or pharmacist.

If Bactroban is used on the face, avoid contact with the eyes. Do not
use Bactroban in the nose, eyes, or areas of venipuncture and central catheter placement.
If the patient uses Bactroban on the face, be careful not to apply it to the eyes or nose or their surroundings.
If the ointment gets into the eye, rinse it thoroughly with water until the ointment is removed.
Do not introduce the medicine into the mouth or swallow it.
A special form is available for use in the nose: Bactroban, nasal ointment.
Do not use Bactroban for more than 10 days.

Bactroban and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
In the case of cracked nipple treatment, wash it thoroughly before breastfeeding.
Bactroban contains polyethylene glycol (macrogol)(see "Warnings and precautions").

3. How to use Bactroban

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

Using the medicine

Do not mix Bactroban with other ointments or creams, as this may reduce its effectiveness.
Typically, Bactroban is applied to the skin up to 3 times a day.

• 1. Wash and dry your hands.
• 2. Apply a small amount of ointment to a piece of clean cotton or gauze.
• 3. Apply the ointment to the affected area of the skin using the cotton or gauze.
• 4. If necessary, cover the treated area with a dressing, unless your doctor advises you to leave it uncovered.
• 5. Close the tube and wash your hands.

How long to use Bactroban

Use Bactroban for as long as your doctor has prescribed. If you have doubts, consult your doctor or pharmacist. Bacteria usually die within 10 days of starting treatment.
Do not use Bactroban for more than 10 days.

Using more Bactroban than prescribed

If you use more Bactroban than prescribed, contact 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 was swallowed.

Missing a dose of Bactroban

If you forget to use Bactroban, 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 Bactroban treatment

If you stop 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 further doubts about using this 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:

• burning sensation at the application site.

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

• itching, redness, stinging, and dryness at the application site.
• allergic rash (hypersensitivity), itching, redness, or skin pain may also affect other parts of the body.

Rare(may affect up to 1 in 1,000 people):
Systemic allergic reactions such as:

• generalized rash, urticaria,
• angioedema (swelling, sometimes also of the face and lips, which may lead to difficulty breathing),
• fainting or loss of consciousness,

contact your doctor immediately.

If the patient experiences skin irritation or hypersensitivity

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

In rare cases, medicines like Bactroban ointment may cause pseudomembranous colitis (inflammation of the colon) - characterized by 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. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 10 days.
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. Each gram of ointment contains 20 mg of mupirocin.
• The other ingredients are: macrogol 400, macrogol 3350.

What Bactroban looks like and contents of the pack

Bactroban is a semi-transparent ointment with a white color and uniform consistency. The medicine is available in aluminum tubes containing 15 g of ointment, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization 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 Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, Ireland
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznań
Poland

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
Spanish marketing authorization number:997585.2
Parallel import authorization number:189/13
Date of leaflet approval: 09.02.2023
[Information about the trademark]