Bactroban 20 mg/g Ointment

Country: Malta

Language: English

Source: Medicines Authority

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

D06AX09

INN (International Name):

MUPIROCIN 20 mg/g

Pharmaceutical form:

OINTMENT

Composition:

MUPIROCIN 20 mg/g

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Product summary:

Licence number in the source country: Spain - 58868: 997585; 997593

Authorization status:

Authorised

Authorization date:

2024-02-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN 20 MG/G OINTMENT
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 20 mg/g Ointment 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.WHAT BACTROBAN IS AND WHAT IT IS USED FOR
Bactroban contains the active substance mupirocin. Bactroban is an
antibiotic ointment.
It is used:
•
to treat skin infections on the skin such as
-
infected hair follicles which form pimples containing pus
(“folliculitis”),
-
an infectious skin infection with blistering and crusting known as
“impetigo”
-
recurring boils (“furunculosis”)
•
This ointment is for external use on your skin 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 ingredients of this
medicine
(listed in section 6).
•
if you have kidney problems as the ointment contains polyethylene
glycol.
Warnings and precautions
* Only marketed pack size(s) will be shown.
•
Talk to your doctor or pharmacist before using Bactroban. Do not use
Bactroban in your nose or eyes. If you are using Bactroban on your
face, be careful not
to use it in or near your eyes or nose. For infections of the inner
nose, a different ointment
will be prescribed.
•
Do not put Bactroban into your mouth or

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban 20 mg/g Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 20 mg mupirocin (20 mg/g mupirocin free
acid).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment - Almost white ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bactroban Ointment is indicated for the treatment of acute primary
bacterial skin
infections e.g. impetigo and folliculitis due to organisms sensitive
to the active
ingredient.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) and children: _
Bactroban Ointment should be applied to the affected area up to three
times a day for
up to 10 days, depending on the response. Dosage should not exceed ten
days.
The area may be covered with a dressing or occluded if desired.
Method of administration
Cutaneous use.
Do not mix with other preparations as there is a risk of dilution,
resulting in a
reduction of the antibacterial activity and potential loss of
stability of the mupirocin
in the ointment.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Page 2 of 6
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In the rare event of a possible sensitisation reaction or severe local
irritation occur
with the use of the product, treatment should be discontinued, the
product should be
wiped off and appropriate alternative therapy for the infection
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