BACTROBAN 2% Cream

Зміст інструкції

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

Bactroban Nasale 20 mg/g Unguento

Mupirocina

Read this leaflet carefully before you use 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 their symptoms are the same as yours, as it could 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 Nasale is and what it is used for
• 2. What you need to know before you use Bactroban Nasale
• 3. How to use Bactroban Nasale
• 4. Possible side effects
• 5. How to store Bactroban Nasale
• 6. Contents of the pack and other information

1. What is Bactroban Nasale and what is it used for

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

• eliminating a group of bacteria in the nose, called Staphylococcus aureus,
• this group includes strains of methicillin-resistant Staphylococcus aureus.

2. What you need to know before using Bactroban Nasale

Do not use Bactroban Nasale:

• if you are allergic to calcium mupirocinate, 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 Nasale.

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

• Bactroban Nasale 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 Nasale is not indicated for ophthalmic use,.
• 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 Bactroban Nasale is used for long periods, thrush (a fungal infection) may develop.
If this happens, inform your doctor or pharmacist. Prolonged use may lead to the development of resistant bacterial strains.
Keep the ointment away from your eyes.
If the ointment accidentally comes into contact with your eyes, wash them thoroughly with
water.

Other medicines and Bactroban Nasale
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
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Use Bactroban Nasale during pregnancy only if strictly necessary and under strict
medical supervision

Driving and operating machinery
Bactroban Nasale does not impair the ability to drive or operate machinery.

3. How to use Bactroban Nasale

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Bactroban Nasale is applied in the nose twice a day for 5 days.

• 1. Wash your hands thoroughly and dry them.
• 2. Apply a small amount of Bactroban Nasale, approximately the size of a match head, to your little finger
• 3. Apply it inside one nostril to the front part.
• 4. Repeat steps 2 and 3 for the other nostril.
• 5. Press on the sides of your nose together to distribute the ointment around the nostril.
• 6. Close the tube with the cap and wash your hands.

A cotton swab can be used instead of your little finger to apply the ointment,
especially in children or seriously ill patients.
Do not mix Bactroban Nasale with other creams or ointments for external use on the infected skin area as this may reduce the effectiveness of the product.

For how long to use Bactroban Nasale?
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 nose within 3-5 days from the start of treatment.
The treatment should not exceed 10 days.
If after a week of treatment you do not notice any improvement or if the infection worsens
inform your doctor.
Dispose of any remaining product at the end of the treatment.

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

If you forget to use Bactroban Nasale

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

If you stop using Bactroban Nasale
If you stop using Bactroban too soon, not all bacteria may have been eliminated and
may continue to grow. Contact your doctor or pharmacist if you decide to 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
• inform your doctor as soon as possible.

The following side effects may occur with this medicine:

Uncommon(may affect up to 1 in 100 people)

• Itching, redness (erythema), burning, tingling or stinging pain in the nose.

Very rare(may affect up to 1 in 10,000 people)

• Some people may develop a severe skin reaction or allergy. Symptoms may include rash, hives, swelling of the skin and mucous membranes (angioedema), itching, redness or pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Nasale

• Keep out of sight and reach of children.
• Do not store at a temperature above 25°C.
• Do not use Bactroban Nasale 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 Nasale if it appears different from normal (see “Description of the appearance of Bactroban Nasale 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 Nasale contains

• The active ingredient is mupirocin. 1 g of nasal ointment contains 20 mg of mupirocin.
• The other ingredients are petrolatum and glycerin esters.

Description of the appearance of Bactroban Nasale and contents of the pack

• Bactroban Nasale is a white, homogeneous ointment.
• Bactroban Nasale is available in a 3 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 Operations UK Ltd - Harmire Road – Barnard Castle – United Kingdom

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