Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Bactroban
20 mg/g (2%) ointment
Mupirocin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Bactroban is and what it is used for
Important information before using Bactroban
How to use Bactroban
Possible side effects
How to store Bactroban
Contents of the pack and other information

1. What Bactroban is and what it is used for

Bactroban ointment contains an antibiotic called mupirocin. It is used for:

the topical treatment of primary and secondary bacterial skin infections caused by mupirocin-sensitive strains of bacteria Staphylococcus aureus, including methicillin-resistant strains (a type of antibiotic), and Streptococcus pyogenes,
the treatment of skin infections such as:
- impetigo (an infectious skin disease causing a painless, red rash with numerous pustular blisters),
- folliculitis (infection of hair follicles),
- furunculosis,
- in the course of various dermatoses (skin disorders),
- for the prevention of infections in traumatic skin lesions, such as minor lacerations, sutured wounds, and abrasions.

This ointment is intended for topical use on the skin only.

2. Important information before using Bactroban

When not to use Bactroban
Do not use Bactroban if the patient is allergic to mupirocin, polyethylene glycol (listed in section 6 of this leaflet as macrogol), or to any of the other ingredients of this medicine (listed in section 6).
If in doubt about using this medicine, consult a doctor or pharmacist.

Warnings and precautions
Before starting treatment with Bactroban, discuss it with a doctor or pharmacist.
Since Bactroban contains polyethylene glycol, consult a doctor or pharmacist before use if:

the patient has impaired kidney function, open wounds, or skin lesions requiring treatment over large areas of the body.
If an allergic reaction or severe local irritation occurs, discontinue treatment, wash the product off the skin thoroughly, and consult a doctor or pharmacist.

When applying Bactroban to the facial skin, avoid contact with the eyes. Do not use Bactroban in the nose, eyes, at the site of a venflon, or at the site of a central line insertion.
If Bactroban is applied to the facial skin, take care to avoid contact with the eyes or nose, or areas nearby.
If the ointment gets into the eye, rinse thoroughly with water until all traces of the ointment are removed.
Do not introduce the medicine into the mouth or swallow it.
A special formulation, Bactroban nasal ointment, is available for use in the nose.
Do not use Bactroban for longer than 10 days.

Bactroban and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
If treatment involves a cracked nipple, it should be washed thoroughly before breastfeeding.

Bactroban contains polyethylene glycol (macrogol) (additional information, see section "Warnings and precautions").

3. How to use Bactroban

This medicine should always be used as directed by the physician.
If in doubt, consult your doctor or pharmacist.
How to use the medicine
Do not mix Bactroban ointment with other ointments or creams, as this may reduce its effectiveness.
Bactroban is usually applied to the skin up to 3 times daily.

Wash and dry your hands.
Apply a small amount of ointment onto a piece of clean cotton wool or gauze.
Apply the ointment to the affected area of skin using the cotton wool or gauze.
The treated area may be covered with a dressing if necessary, unless your doctor has advised leaving the area uncovered.
Replace the cap on the tube and wash your hands.

How long to use Bactroban
Continue using Bactroban for as long as your doctor has instructed. If in doubt, consult your doctor or pharmacist. Bacteria are usually eliminated after 10 days of treatment.
Do not use Bactroban for longer than 10 days.
Use of more than the recommended dose of Bactroban
If more Bactroban than recommended has been used, contact your doctor or pharmacist. Carefully remove any excess ointment.
If Bactroban has been swallowed, contact your doctor immediately and inform them what and how much has been ingested.
Missed dose of Bactroban
If the patient forgets to apply the medicine, apply it as soon as they remember. If the next dose is due within one hour, skip the missed dose.
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Bactroban
If the patient stops using Bactroban too early, not all bacteria may be killed or they may continue to multiply. Consult your doctor or pharmacist about when to stop using the ointment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below is a list of possible adverse reactions associated with this medicine.

Common (may occur in 1 in 10 to 1 in 100 patients):

burning sensation at the application site.

Uncommon (may occur in 1 in 100 to 1 in 1000 patients):

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

Very rare (may occur in fewer than 1 in 10,000 patients):
Systemic allergic reactions such as:

generalized rash, urticaria,
angioedema (swelling, sometimes affecting the face and lips, which may lead to breathing difficulties),
fainting or loss of consciousness.

► If any of these symptoms occur, stop using the medicine immediately and contact your doctor without delay.

If skin irritation or hypersensitivity occurs in the patient:

remove the ointment from the skin,
discontinue use of the medicine,
inform the treating physician as quickly as possible.

In rare cases, medicines such as Bactroban ointment may cause inflammation of the colon (large intestine) – presenting as diarrhoea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact your doctor as quickly as possible.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps 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 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 stated month.
Do not use Bactroban if it looks different than usual (see description in section 6).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Bactroban contains

The active substance is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
Other ingredients: macrogol 400, macrogol 3350.

What Bactroban looks like and contents of the pack
Bactroban is a white, semi-transparent ointment of uniform consistency. The medicine is
available in an aluminium tube containing 15 g of ointment, packed in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
GlaxoSmithKline Monoprosopi A.E.B.E.
L. Kifisias 266, Chalandri, 152 32 Athens, Greece
Manufacturer:
Glaxo Operations UK Ltd
Barnard Castle
United Kingdom
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24,
Ireland
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Greece, the country of export: 51019/4-7-2013
11973/26-3-2019
Parallel Import Licence Number: 168/20