Bactroban Nasal Ointment 2.0% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mupirocin calcium

Available from:

Imbat Limited

ATC code:

R01AA; R01AA06; R01AX; R01AX06

INN (International Name):

Mupirocin calcium

Dosage:

2 Base %w/w

Pharmaceutical form:

Nasal ointment

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Sympathomimetics, plain; tetryzoline; Other nasal preparations; mupirocin

Authorization status:

Authorised

Authorization date:

2012-02-17

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN
® NASAL OINTMENT 2.0% W/W
(mupirocin, as mupirocin calcium)
Your medicine is available using the above name but will be
referred to as Bactroban throughout this leaflet.
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:
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 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 BACTROBA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bactroban Nasal Ointment 2.0% 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 imported from the United Kingdom:_
An off-white, smooth 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 is the date shown on the
bottle and out carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tube fitted with a nozzle and a screw cap containing 3g of
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
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Ltd
Unit L2
North Ring Business Park
Santry
Dublin 9
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/169/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE