Bactroban 2% nasal ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mupirocin calcium

Available from:

Dowelhurst Ltd

ATC code:

R01AX06

INN (International Name):

Mupirocin calcium

Dosage:

20mg/1gram

Pharmaceutical form:

Nasal ointment

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12020300

Patient Information leaflet

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,
pharmacist or nurse.
Keep the ointment away from your eyes.
-
If the ointment gets into your eyes accidentally, wash them thoroughly
with water.
OTHER MEDIC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bactroban 2% 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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The
elimination
of
nasal
carriage
of
staphylococci,
including
methicillin
resistant _Staphylococcus 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.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND 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 occur with topically
applied
mupirocin, if prol