Package Leaflet: Information for the user BACTROBAN® 2%w/w NASAL OINTMENT (mupirocin calcium)

Read all of this leaflet carefully before you start using this medicine.

•    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. 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.

The name of your medicine is Bactroban 2%w/w Nasal Ointment but will be referred to as Bactroban throughout this leaflet.

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 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 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, nurse or pharmacist before using Bactroban.

Warning 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 Bactorban

Please tell your doctor, nurse 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 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 Bactorban

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, this medicine 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.

Your ointment will have an expiry date on the pack. You should not use your ointment after this date.

Do not store above 25°C.

Return any leftover medicine to your pharmacist. Do not keep it for further use.

6. Contents of the pack and other information

What Bactroban contains

Bactroban contains 2%w/w mupirocin. This is the active ingredient.

Bactroban has a white, soft paraffin base also containing a mixed diglycerin ester of fatty acids.

What Bactroban looks like and contents of the pack

Bactroban is available in 3 g tubes.

Manufactured by: Glaxo Wellcome Operations, Harmire Road, Durham, DL12 8DT, Barnard Castle, UK.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.

Bactroban 2%w/w Nasal Ointment PL No: 18799/1426 IPQMl Leaflet date: 24.09.2014

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

Package Leaflet: Information for the user MUPIROCIN 2%w/w NASAL OINTMENT (mupirocin calcium)

Read all of this leaflet carefully before you start using this medicine.

•    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. 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.

The name of your medicine is Mupirocin 2%w/w Nasal Ointment but will be referred to as Mupirocin throughout this leaflet.

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 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 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, nurse or pharmacist before using Mupirocin.

Warning 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

Please tell your doctor, nurse 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 this medicine exactly as your doctor has told you. You should check with your doctor 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, this medicine 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.

Your ointment will have an expiry date on the pack. You should not use your ointment after this date.

Do not store above 25°C.

Return any leftover medicine to your pharmacist. Do not keep it for further use.

6. Contents of the pack and other Information

What Mupirocin contains

Mupirocin contains 2%w/w mupirocin. This is the active ingredient.

Mupirocin has a white, soft paraffin base also containing a mixed diglycerin ester of fatty acids.

What Mupirocin looks like and contents of the pack

Mupirocin is available in 3 g tubes.

Manufactured by: Glaxo Wellcome Operations, Harmire Road, Durham, DL12 8DT, Barnard Castle, UK.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.

Mupirocin 2%w/w Nasal Ointment PL No: 18799/1426 IPQMl Leaflet date: 24.09.2014