Bactroban

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Bactroban

20 mg/g, ointment

Mupirocin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects 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 packaging 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 (antibiotic) 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 scratched wounds, sutured wounds, and 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, you should consult a doctor or pharmacist.

Warnings and precautions

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

• the patient has kidney function disorders, open wounds, or skin damage requiring treatment of large areas of the body. If an allergic reaction or severe local irritation occurs, treatment should be discontinued, the product should be washed off the skin, and a doctor or pharmacist should be consulted.

If Bactroban is used on the face, you should avoid contact with the eyes. Do notuse Bactroban in the nose, eyes, at the site of a venflon, or at the site of central injection.If the patient uses Bactroban on the face, they should be careful not to apply it to the eyes or nose or near them. If the ointment gets into the eye, it should be rinsed thoroughly with water until the residue 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

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines 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 a doctor or pharmacist before using this medicine. If the treatment concerns a cracked nipple, it should be washed very thoroughly before breastfeeding. Bactroban contains polyethylene glycol (macrogol)(see "Warnings and precautions").

3. How to use Bactroban

This medicine should always be used as directed by your doctor. In case of doubts, you should consult a doctor, pharmacist, or nurse.

Using the medicine

Do not mix Bactroban with other ointments or creams, as this may reduce its effectiveness. Bactroban is usually 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. The treated area can be covered with a dressing if necessary, unless the doctor advises against it.
• 5. Close the tube and wash your hands.

How long to use Bactroban

You should use Bactroban for as long as your doctor advises. If you have any doubts, you should 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 recommended

If you use more Bactroban than recommended, you should contact your doctor, pharmacist, or nurse. Carefully remove any excess ointment. If you swallow Bactroban, you should 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, you should use it as soon as you remember. If the next dose is due within an hour, you should skip the missed dose. Do not use a double dose to make up for the missed dose.

Stopping Bactroban treatment

If you stop using Bactroban too early, not all bacteria may be killed, or they may continue to multiply. You should ask your doctor or pharmacist when to stop using the ointment. If you have any further doubts about using this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bactroban can cause side effects, although not everybody gets them. The following are side effects of Bactroban that may occur:

• burning 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):

• generalized rash, urticaria (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 medicine
• inform the doctor as soon as possible

In rare cases, medicines like Bactroban ointment may cause pseudomembranous colitis (inflammation of the colon) - characterized by the onset of diarrhea, usually bloody and containing mucus, abdominal pain, fever (pseudomembranous colitis). If you experience any of these symptoms, you should contact a doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 gather more information on the safety of the medicine.

5. How to store Bactroban

The medicine should be stored out of 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 stated. The shelf life after first opening the tube is 10 days. Do not use Bactroban if it looks different from normal (see description in point 6). Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bactroban contains

• The active substance of Bactroban is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
• The other ingredients are: macrogol 400, macrogol 3350.

What Bactroban looks like and what the pack contains

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, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Stiefel Farma, S.A. PTM-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

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warszawa Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warszawa Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń IVA Pharm Sp. z o.o. ul. Drawska 14/1 02-202 Warszawa CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Marketing authorization number in Spain, the country of export: 997585.2 Parallel import authorization number: 329/20

Date of leaflet approval: 31.08.2023

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