BACTROBAN 20 mg /G Cream

Зміст інструкції

1. Bactroban 20 mg/g ointment
   1. What is Bactroban and what is it used for
   2. What you need to know before you use Bactroban
   3. How to use Bactroban
   4. Possible side effects
   5. HOW TO STORE BACTROBAN
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Bactroban 20 mg/g ointment

Mupirocin

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bactroban is and what it is used for
• 2. What you need to know before you use 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

a medicine called mupirocin.
Bactroban is an antibiotic ointment.
It is used for the topical treatment of primary and secondary pyodermas (skin infections
caused by bacteria).

2. What you need to know before you use Bactroban

Do not use Bactroban:

• if you are allergic (hypersensitive) to mupirocin or any of the other ingredients of this medicine (listed in section 6).

If you are not sure if this applies to you, do not use this medicine. Talk to your doctor or
pharmacist before using Bactroban.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bactroban

• Bactroban may cause severe skin reactions or allergies. See ‘Conditions to watch out for’ in section 4. In this case, your doctor will advise you to stop treatment and switch to an alternative treatment for infections.
• Bactroban is not indicated for ophthalmic use, intranasal use or on the skin surrounding the insertion of cannulas for therapeutic treatments.
• In rare cases, antibiotic drugs, such as Bactroban, can cause inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis). If you suffer from prolonged diarrhea or if you experience abdominal cramps, contact your doctor immediately.

If you experience any of these symptoms call your doctor as soon as possible.
If Bactroban is used for long periods, thrush (a fungal infection) may develop.
If this happens, inform your doctor, pharmacist or nurse.
Keep the ointment away from your eyes.
If the ointment accidentally comes into contact with your eyes, wash them thoroughly with
water.
.
Patients with renal impairment
If you have moderate or severe renal impairment, your doctor will adjust the dose of treatment.

Other medicines and Bactroban
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.
Use Bactroban during pregnancy only if strictly necessary and under strict medical supervision.
If a damaged nipple needs to be treated, the ointment must be thoroughly washed off before
breastfeeding.

Driving and using machines
Bactroban does not impair the ability to drive or use machines.

Bactroban ointment contains polyethylene glycol
Talk to your doctor before using this medicine if you:

• have kidney problems
• have large open wounds or broken skin to be treated.

3. How to use Bactroban

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Do not mix Bactroban with other creams or ointments on the infected skin area
as this may reduce the effectiveness of Bactroban.
Bactroban is applied to the skin two or three times a day.

• 1. Wash and dry your hands thoroughly.
• 2. Apply a small amount of ointment to the infected skin area.
• 3. The treated area may be covered with a bandage or other suitable dressing, unless your doctor tells you to leave it uncovered.
• 4. Close the tube with the cap and wash your hands.

How long to use Bactroban?
Use Bactroban for the time indicated by your doctor.
If you are not sure, consult your doctor or pharmacist.
Normally, bacteria are eliminated from the skin within 10 days of starting treatment. The
duration of treatment should not exceed 10 days.
If you do not notice any improvement after a week of treatment or if the infection worsens
inform your doctor.
Dispose of any remaining product at the end of treatment.

If you swallow Bactroban
If you accidentally swallow the ointment, ask for advice from your doctor or pharmacist or go to the
nearest hospital. Take the medicine tube with you.

If you forget to use Bactroban

• If you forget to apply Bactroban, apply it as soon as you remember.
• If the next dose is due within an hour, skip the missed dose.
• Do not use a double dose to make up for a missed dose.

If you stop using Bactroban
If you stop using Bactroban too early, not all bacteria may have been eliminated or
may continue to grow.
Consult your doctor or pharmacist when you stop using the ointment.
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to pay attention to
Severe skin reactions or allergies

If you develop a severe skin reaction or an allergy and, in particular, if swelling of the face and difficulty breathing occur:

• wash the ointment off with plenty of water,
• stop using it and
• tell your doctor as soon as possible.

The following side effects may occur with this medicine:

Common(may affect up to 1 in 10 people)

• Burning where the ointment is applied.

Uncommon(may affect up to 1 in 100 people)

• Itching, redness (erythema), skin rash, hives, stinging pain and dryness in the skin area where Bactroban is applied, but also in other parts of the body.
• .

Very rare(may affect up to 1 in 10,000)
Swelling of the face and/or difficulty breathing. These may be symptoms of a severe, widespread allergic reaction that may require emergency treatment.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE BACTROBAN

• Keep out of sight and reach of children.
• Do not store at a temperature above 25°C.
• Do not use Bactroban after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.
• Do not use Bactroban if it appears different from normal (see “Description of the appearance of Bactroban and contents of the pack”).
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bactroban contains

• The active ingredient is mupirocin. 1 g of ointment contains 20 mg of mupirocin.
• The other ingredients are polyethylene glycol 400, polyethylene glycol 3350.

Description of the appearance of Bactroban and contents of the pack

• Bactroban is a white, translucent ointment.
• Bactroban is available in a 15 g tube. Each tube is contained in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via Alessandro Fleming, 2 - Verona

Manufacturer
Glaxo Wellcome Operations - Harmire Road - Barnard Castle – United Kingdom

Other sources of information
More detailed information on this medicine is available on the AIFA website