Bactroban

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Bactroban
20 mg/g, ointment
Mupirocin
Please read the entire 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 another person, 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 of the leaflet

1. What Bactroban is and what it is 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 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 bacterial strains sensitive to mupirocin (the active substance), such as 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 pustules),
  • folliculitis (infection of hair follicles),
  • furunculosis,
  • in various dermatoses (skin disorders),
  • for the prophylaxis of infected traumatic skin lesions, 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 your doctor or pharmacist.
Since Bactroban contains polyethylene glycol (macrogol), consult your doctor or pharmacist before using the medicine 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 facial skin, avoid contact with the eyes. Do not use Bactroban in the nose, eyes, at the site of a venflon, or at a central line insertion site.
If Bactroban is applied to the face, take care to avoid contact with the eyes or 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
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 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 a doctor or pharmacist.
How to use the medicine
Do not mix Bactroban ointment with other creams or ointments, as this may reduce its effectiveness.
Bactroban is usually applied to the skin up to 3 times daily.

1. Wash and dry your hands.
2. Apply a small amount of ointment onto a piece of clean cotton or gauze.
3. Use this to apply the ointment to the affected area of skin.
4. The treated area may be covered with a dressing if necessary, unless the physician advises leaving the area uncovered.
5. Recap the tube and wash your hands.

How long to use Bactroban
Use Bactroban for as long as directed by your physician. If in doubt, contact your physician or pharmacist. Usually, bacteria are eliminated after 10 days of treatment.
Do not use Bactroban for longer than 10 days.
Use of a larger than recommended dose of Bactroban
If more Bactroban ointment than recommended is used, contact your physician, pharmacist, or nurse. Carefully remove any excess ointment.
If Bactroban is swallowed, contact your physician immediately and inform them what and how much has been ingested.
Missed dose of Bactroban
If the patient forgets to apply the medicine, 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 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. Ask your physician or pharmacist when to stop using the ointment.
If you have any further doubts concerning the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below are listed the adverse reactions of this medicine that may occur.
Common (may occur in 1 in 10 to 1 in 100 patients):

• burning 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 (allergic dermatitis), 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 including face and lips, which may lead to breathing difficulties),
• fainting or loss of consciousness,
• if such symptoms occur, discontinue use of the medicine immediately 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 colitis (inflammation of the large intestine) – characterized by the onset of diarrhea, 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 adverse reactions, additional information on the safety of the medicine can be collected.

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.
Usable period after first opening the tube – 10 days.
Do not use Bactroban if it looks different than normal (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 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 components are: macrogol 400, macrogol 3350.

What Bactroban looks like and contents of the pack
Bactroban is an ointment of almost white colour. The medicine is available in aluminium tubes with a screw cap, containing 15 g of ointment, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
GlaxoSmithKline, 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
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań, Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Spain, the country of export: 997585.2
Parallel import licence number: 329/20