Bactroban Nasal Ointment 2% w/w

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Mupirocin
Available from:
PCO Manufacturing Ltd.
ATC code:
R01AX; R01AX06
INN (International Name):
Mupirocin
Dosage:
2.0 percent weight/weight
Pharmaceutical form:
Nasal ointment
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other nasal preparations; mupirocin
Authorization status:
Authorised
Authorization number:
PPA0465/312/001
Authorization date:
2013-07-26

Package leaflet: Information for the user

Bactroban

®

Nasal Ointment 2% w/w

mupirocin

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.

In this leaflet, Bactroban Nasal Ointment

2.0% w/w will be called Bactroban.

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 s and what it is used for

1.

What Bactroban is and what it is used

for

Bactroban contains the active substance

mupirocin as 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 to mupirocin or any of the

other ingredients of this medicine (listed in

Section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using

Bactroban

Do not put Bactroban into your mouth or

swallow it.

Do not put Bactroban in your eyes. If you

get it in your eyes, wash it out

immediately.

If you develop a severe skin reaction or

allergy wipe off the ointment, stop using it

and tell your doctor as soon as possible.

Prolonged use of Bactroban may result in

overgrowth of non-susceptible organisms.

Other medicines and Bactroban

Tell your doctor, nurse or pharmacist if you are

using, have recently used or might use 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 taking this medicine.

Driving and using machines

It is unlikely that Bactroban will affect your

ability to drive or operate machinery.

3.

How to use Bactroban

Always use this medicine exactly as your

doctor has told you. Check with your doctor,

nurse or pharmacist if you are not sure.

Using this medicine

You usually apply Bactroban to your nose two

or three times a day.

Wash and dry your hands.

Place a small amount of Bactroban, about

the size of a match head, on your little

finger.

Apply this to the inside of one nostril.

Repeat steps 2 and 3 for your other

nostril.

Press the sides of your nose together to

spread the ointment around the nostril.

Replace the cap on the tube and wash

your hands.

Small children or very ill people

Use a cotton bud instead of your little finger to

apply the ointment. With these patients, special

care should be taken.

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 5 to 7 days of

starting treatment. Any product remaining at the

end of treatment should be discarded

If you use more Bactroban than you should

If you use more Bactroban than you should,

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.

The following side effects may happen with this

medicine:

Uncommon (may affect up to 1 in 100 people)

A runny nose

Itching, redness, burning, tingling and/or

stinging of the nose.

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

Allergic rash, itching, redness or soreness

of the skin can also occur on other parts of

your body

Raised and itchy rash, swelling,

sometimes of the face or mouth, causing

difficulty in breathing, collapse or loss of

consciousness. This may be a sign of a

serious allergic reaction that could require

emergency treatment.

If you develop a severe skin reaction or

allergy:

wipe off the ointment

stop using it and

tell your doctor as soon as possible.

On rare occasions, medicines like Bactroban

can cause inflammation of the colon (large

intestine), causing diarrhoea, usually with blood

and mucus, stomach pain, fever

(pseudomembranous colitis).

Tell your doctor as soon as possible if

you get any of these symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can

also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, Dublin 2,

Ireland; Tel: +353 1 6764971;

Fax: +353 1 6762517; Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide

more information on the safety of this medicine.

5.

How to store Bactroban

Keep this medicine out of the sight and

reach of children.

Do not store above 25º C.

Do not use this medicine after the expiry

date which is stated on the carton and

tube after EXP or CAD. The expiry date

refers to the last day of that month.

Do not use it if it looks different to normal.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will

help protect the environment.

6.

Contents of the pack and other

information

What Bactroban contains

The active substance is mupirocin. Each

1g of nasal ointment contains 20mg of

mupirocin (as mupirocin calcium).

The other ingredients are white soft

paraffin and mixed diglycerin ester of fatty

acids (Softisan 649).

What Bactroban looks like and contents of

the pack

Product imported from the UK is a smooth

white ointment.

Product imported from Spain is an

ointment.

Bactroban is available in a 3 g tube. Each

tube comes in a carton.

Manufacturer:

Glaxo Wellcome Operations, Harmire Road,

Barnard Castle, Co Durham, DL12 8DT,

United Kingdom or GlaxoSmithKline

Pharmaceuticals S.A.,ul. Grunwaldzka 189, 60-

322 Poznan, Poland.

Product Authorisation number: PPA

465/312/1

Product procured from within the EU,

repackaged and distributed by the Parallel

Product Authorisation holder:

PCO Manufacturing Ltd., Unit 10, Ashbourne

Business Park, Rath, Ashbourne, Co. Meath,

Ireland,

Bactroban is a registered trademark of Glaxo

Group Limited.

This leaflet was last revised in January

2020.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bactroban Nasal Ointment 2% w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Mupirocin 2.0% w/w as mupirocin calcium.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nasal ointment.

Product sourced from the UK:

A smooth white ointment.

Product imported from Spain:

An ointment.

4 CLINICAL PARTICULARS

As per PA1077/094/002

5 PHARMACOLOGICAL PROPERTIES

As per PA1077/094/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

Mixed diglycerin ester of fatty acids (softisan 649)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on

the market in the country of origin.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Lacquered aluminium tube fitted with a nozzle and screw cap containing 3g white ointment.

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6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Any product remaining at the end of treatment should be discarded.

Wash your hands after application.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/312/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26

July 2013

10 DATE OF REVISION OF THE TEXT

December 2016

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