Package Leaflet: Information for the user

Bactroban® 2% Nasal Ointment

mupirocin calcium

Read all of this leaflet carefully before you start using this

medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, nurse or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 Bactroban is and what it is used for

Bactroban 2% Nasal Ointment (called ‘Bactroban' in this leaflet) contains a medicine called mupirocin calcium. Bactroban is an antibiotic ointment.

It is used:

•    to kill a group of bacteria in the nose called 'Staphylococci'

•    this group includes MRSA (Methicillin Resistant Staphylococcus aureus)

•    this ointment is for use in your nose only.

2 What you need to know before you use Bactroban

Do not use Bactroban if:

• you are allergic (hypersensitive) to mupirocin calcium, mupirocin or any of the other ingredients of Bactroban (listed in Section 6).

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

Warnings and precautions

Bactroban can cause severe skin reactions or allergies. See ‘Conditions to look out for' in Section 4.

Thrush (a yeast infection) may develop if Bactroban is used for a long time. If this occurs, tell your doctor, pharmacist or nurse.

Keep the ointment away from your eyes.

- If the ointment gets into your eyes accidentally, wash them thoroughly with water.

Other medicines and Bactroban

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

3 How to use Bactroban

Always use this medicine exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.

Using this medicine

You usually apply Bactroban to your nose twice a day.

1.    Wash and dry your hands.

2.    Place a small amount of Bactroban, about the size of a match head, on your little finger.

3.    Apply this to the inside of one nostril.

4.    Repeat steps 2 and 3 for your other nostril.

5.    Press the sides of your nose together to spread the ointment around the nostril.

6.    Replace the cap on the tube and wash your hands.

A cotton bud can be used instead of your little finger to apply the ointment, particularly in infants or the very ill.

How long should you use Bactroban for?

Use Bactroban for as long as your doctor has told you. If you are not sure, ask your doctor, nurse or pharmacist. The bacteria are normally cleared from your nose within 3 to 5 days of starting treatment. Do not use for more than 10 days.

If you swallow any Bactroban

If you swallow any of the ointment, speak to your doctor, nurse or pharmacist for advice.

If you forget to use Bactroban

•    If you forget to apply Bactroban, apply it as soon as you remember.

•    If your next dose is due within an hour, skip the missed dose.

•    Do not use a double dose to make up for a forgotten dose.

If you stop using Bactroban

If you stop using Bactroban too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, nurse or pharmacist when to stop using the ointment.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4 Possible side effects

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

Conditions to look out for

Severe skin reactions or allergies - If you develop a severe skin reaction or an allergy:

•    wash off the ointment

•    stop using it and

•    tell your doctor as soon as possible.

The following side effects may happen with this medicine:

Uncommon (may affect up to 1 in 100 people)

•    Itching, redness, burning, tingling or stinging of the nose.

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

•    Some people can develop a skin reaction or allergy that is severe. The signs can include a rash, itchiness, redness or soreness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This include any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Bactroban

•    Keep out of the sight and reach of children.

•    Do not store above 25 °C.

•    Do not use Bactroban after the expiry date which is stated on the carton, tube & overlabels. The expiry date refers to the last day of that month.

•    Do not use Bactroban if it looks different to normal.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Contents of the pack and other information

What Bactroban contains

•    The active substance is 2% w/w mupirocin (as mupirocin calcium).

•    The other ingredients are white soft paraffin and softisan 649.

What Bactroban looks like and contents of the pack

•    Bactroban is a smooth white ointment.

•    Bactroban is available in a 3 g tube. Each tube comes in a carton.

Manufactured by: Glaxo Wellcome Operations, Harmire Road- County Durham, DL12 8dT Barnard Castle, Uk

Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Limited., 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL, UK.

Bactroban 2% nasal ointment, PLPI 39352/0071

Bactroban® is a registered trademark of the GlaxoSmithKline group of companies.

Mupirocin 2% Nasal Ointment

mupirocin calcium

Read all of this leaflet carefully before you start using this

medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, nurse or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1    What Mupirocin is and what it is used for

2    What you need to know before you use Mupirocin

3    How to use Mupirocin

4    Possible side effects

5    How to store Mupirocin

6    Contents of the pack and other information

1 What Mupirocin is and what it is used for

Mupirocin 2% Nasal Ointment (called ‘Mupirocin' in this leaflet) contains a medicine called mupirocin calcium. Mupirocin is an antibiotic ointment.

It is used:

•    to kill a group of bacteria in the nose called 'Staphylococci'

•    this group includes MRSA (Methicillin Resistant Staphylococcus aureus)

•    this ointment is for use in your nose only.

2 What you need to know before you use Mupirocin

Do not use Mupirocin if:

• you are allergic (hypersensitive) to mupirocin calcium, mupirocin or any of the other ingredients of Mupirocin (listed in Section 6).

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

Warnings and precautions

Mupirocin can cause severe skin reactions or allergies. See ‘Conditions to look out for' in Section 4.

Thrush (a yeast infection) may develop if Mupirocin is used for a long time. If this occurs, tell your doctor, pharmacist or nurse.

Keep the ointment away from your eyes.

- If the ointment gets into your eyes accidentally, wash them thoroughly with water.

Other medicines and Mupirocin

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

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

3 How to use Mupirocin

Always use Mupirocin exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.

Using this medicine

You usually apply Mupirocin to your nose twice a day.

1.    Wash and dry your hands.

2.    Place a small amount of Mupirocin, about the size of a match head, on your little finger.

3.    Apply this to the inside of one nostril.

4.    Repeat steps 2 and 3 for your other nostril.

5.    Press the sides of your nose together to spread the ointment around the nostril.

6.    Replace the cap on the tube and wash your hands.

A cotton bud can be used instead of your little finger to apply the ointment, particularly in infants or the very ill.

How long should you use Mupirocin for?

Use Mupirocin for as long as your doctor has told you. If you are not sure, ask your doctor, nurse or pharmacist. The bacteria are normally cleared from your nose within 3 to 5 days of starting treatment. Do not use for more than 10 days.

If you swallow any Mupirocin

If you swallow any of the ointment, speak to your doctor, nurse or pharmacist for advice.

If you forget to use Mupirocin

•    If you forget to apply Mupirocin, apply it as soon as you remember.

•    If your next dose is due within an hour, skip the missed dose.

•    Do not use a double dose to make up for a forgotten dose.

If you stop using Mupirocin

If you stop using Mupirocin too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, nurse or pharmacist when to stop using the ointment.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4 Possible side effects

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

Conditions to look out for

Severe skin reactions or allergies - If you develop a severe skin reaction or an allergy:

•    wash off the ointment

•    stop using it and

•    tell your doctor as soon as possible.

The following side effects may happen with this medicine:

Uncommon (may affect up to 1 in 100 people)

•    Itching, redness, burning, tingling or stinging of the nose.

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

•    Some people can develop a skin reaction or allergy that is severe. The signs can include a rash, itchiness, redness or soreness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This include any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Mupirocin

•    Keep out of the sight and reach of children.

•    Do not store above 25 °C.

•    Do not use Mupirocin after the expiry date which is stated on the carton, tube & overlabels. The expiry date refers to the last day of that month.

•    Do not use Mupirocin if it looks different to normal.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Contents of the pack and other information

What Mupirocin contains

•    The active substance is 2% w/w mupirocin (as mupirocin calcium).

•    The other ingredients are white soft paraffin and softisan 649.

What Mupirocin looks like and contents of the pack

•    Mupirocin is a smooth white ointment.

•    Mupirocin is available in a 3 g tube. Each tube comes in a carton.

Manufactured by: Glaxo Wellcome Operations, Harmire Road- County Durham, DL12 8dT Barnard Castle, Uk

Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL, UK.

Mupirocin 2% nasal ointment, PLPI 39352/0071

Leaflet date: 17.06.2014