Package leaflet: Information for the user

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

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Leaflet 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:

Local treatment of primary and secondary bacterial skin infections caused by mupirocin-sensitive (active substance of the medicine) strains of bacteria Staphylococcus aureus, including methicillin-resistant strains (antibiotic), and Streptococcus pyogenes.
Treatment of skin infections such as:
Impetigo (a contagious skin disease causing painless, red rash with numerous pustular blisters),
Infections of hair follicles,
Furunculosis,
In the course of various dermatoses (skin diseases),
For prophylaxis of traumatic skin lesion infections, such as minor lacerations, sutured wounds, and abrasions.

This ointment is intended for topical use 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 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 of large body surface areas.

In case of an allergic reaction or severe local irritation, discontinue treatment, wash the medicine off the skin thoroughly, and consult a doctor or pharmacist.

When applying Bactroban to the facial skin, avoid contact with the eyes. Do not apply Bactroban to the nose, eyes, venflon site, or central access site.
If the patient is using Bactroban on the facial skin, care must be taken to avoid applying it to the eyes, nose, or areas near them.
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
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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.
Use it to apply the ointment to the affected area of skin.
The treated area may be covered with a dressing if necessary, unless your doctor advises otherwise.
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. Usually, bacteria are 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 ointment, it should be applied as soon as remembered. If the next dose is due within one hour, skip the missed dose.
Do not apply a double amount to make up for a missed dose.
Stopping Bactroban treatment
If Bactroban treatment is stopped 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The adverse effects of this medicine that may occur are listed below.
Common (may occur in 1 in 10 to 1 in 100 patients):

burning sensation at the site of application.

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

itching, redness, stinging, and dryness at the site of application.
allergic rash (hypersensitivity), itching, redness, or pain of the skin 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 and contact a doctor immediately.
If skin irritation or hypersensitivity occurs:

remove the ointment from the skin,
discontinue use of the medicine,
inform the doctor 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 a doctor as quickly as possible.

Reporting adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bactroban

Keep this medicine out of 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 from the normal appearance (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 in use.
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, white, homogeneous ointment. The medicine is available in aluminium tubes containing 15 g of ointment, packed in cardboard boxes.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
GlaxoSmithKline Monoprosopi A.E.B.E.
Leof. Kifisias 266
152 32 Chalandri
Greece
Manufacturer:
Glaxo Operations UK Ltd, Barnard Castle, United Kingdom
GlaxoSmithKline Pharmaceuticals S.A., Grunwaldzka 189, 60-322 Poznań, Poland
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation numbers in Greece, the country of export: 11973/26-3-2019
51019/4-7-2013
Parallel import authorisation number: 40/20