Bactroban 2% Nasal Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MUPIROCIN

Available from:

Beecham Group PLC

ATC code:

D06AX09

INN (International Name):

MUPIROCIN

Pharmaceutical form:

OINTMENT

Composition:

MUPIROCIN 2 % (W/W)

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2005-11-24

Patient Information leaflet

Reason for Update: Type II GDS 15
Market: UK
Agency Approval Date: 07/07/2016
Text Date: 01/04/2016
Text Issue and Draft No.: Issue 4, Draft 2
1
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 the active substance
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.
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, pharmaci

Summary of Product characteristics

_ _
_ _
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban2% Nasal Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains mupirocin calcium equivalent to
20 mg
mupirocin (2% w/w mupirocin free acid)
3.
PHARMACEUTICAL FORM
White soft paraffin based nasal-ointment containing a glycerin ester.
Off-white smooth ointment
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The elimination of nasal carriage of staphylococci, including
methicillin
resistant S_taphylococcus aureus_ (MRSA).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults (including the elderly) and children: _
Bactroban Nasal Ointment should be applied to the anterior nares two
to three
times a day as follows:
A small amount of the ointment about the size of a match head is
placed on the
little finger and applied to the inside of each nostril. The nostrils
are closed by
pressing the sides of the nose together; this will spread the ointment
throughout the nares. A cotton bud may be used instead of the little
finger for
the application in particular to infants or patients who are very ill.
Nasal carriage should normally clear within 5-7 days of commencing
treatment.
Method of administration_ _
Topical.
_ _
_ _
Page 2 of 7
4.3
CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Should a possible sensitisation reaction or severe local irritation
occur with the
use of Bactroban Nasal Ointment, treatment should be discontinued, the
product should be wiped away and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in
overgrowth
of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics
and
may range in severity from mild to life-threatening. Therefore, it is
important
to consider its diagnosis in patients who develop diarrhoea during or
after
antibiotic use. Although this is less likely to