FUCIDIN OINTMENT

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SODIUM FUSIDATE

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

SODIUM FUSIDATE

Units in package:

15gm mcg/mL; 5gm mcg/mL

Manufactured by:

LEO LABORATORIES

Patient Information leaflet

FUCIDIN
® OINTMENT
Sodium Fusidate (20 mg/g)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Fucidin_
_®_
_ Ointment_
is used for
2.
How
_Fucidin_
_®_
_ Ointment_
works
3.
Before you use
_Fucidin_
_®_
_ Ointment_
4.
How to use
_Fucidin_
_®_
_ Ointment_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Fucidin_
_®_
_ _
_Ointment_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _FUCIDIN_
_®_
_ OINTMENT_
IS USED FOR
_Fucidin_
_®_
_ _
_Ointment_
is
used
to
treat
conditions where the skin is infected by
germs (bacteria), such as:

Impetigo (a weeping, crusty and
swollen patch of skin)

Infected
dermatitis
(inflammation of the skin) and
spots

Infected cuts and grazes.

Your
doctor
may
have
prescribed
this
medication
for
another reason. Ask your doctor
if you have any questions about
why this medication has been
prescribed for you.
HOW _FUCIDIN_
_®_
_ OINTMENT_
WORKS
_Fucidin_
_®_
_ _
_Ointment_
contains
sodium
fusidate. It is a type of antibiotic.
_Fucidin_
_®_
_ _
_Ointment_
works
by
killing
germs (bacteria) that cause infections.
BEFORE YOU USE _FUCIDIN_
_®_
_ OINTMENT_
-
_When you must not use it _
_ _
Do not use
_ Fucidin_
_®_
_ Ointment_
_ _

If
you
are
allergic
(hypersensitive) to fusidic acid
or sodium fusidate.

If
you
are
allergic
(hypersensitive)
to
any
of
the
other
ingredients
in
your
medicine. You can find a list of
these ingredients in section 6:
_Side Effects_
of this leaflet

If you have infections caused by
non-susceptible organisms.
_ _
_ _
_Pregnancy and lactation _
Please ask your doctor or pharmacist for
advice before using
_Fucidin_
_®_
_ Ointment_
:

If you are pregnant, or think you
are pregnant.

If you are breast-feeding.
-
_Before you start to use it _
Take
special
care
with
_Fucidin_
_®_
_ _
_Ointment_

Take
special
care
if
you
are
going to use this medicine near
your eyes or the eyes of a child.
-
_Taking other medicines _
_

Summary of Product characteristics

Fucidin ®
Plain topical antibiotic
Ointment
Sodium fusidate 20 mg/g in neutral ointment base.
Pack Sizes: 5g, 15g
Product Description
Translucent yellowish to white ointment .
Properties
Sodium fusidate, an antibiotic derived from Fusidium coccineum, exerts powerful antibacterial activity
against a number of gram -positive organisms.
Staphylococci, including the strains resistant to penicillin or to other antibiotics, are particularly
susceptible to sodium fusidate. The therapeutic efficacy of topically applied Fucidin ® ointment is due
partly to the pronounced antibacterial activity of sodium fusidate against the organisms responsible for
skin infections, and partly to the unique ability of this antibiotic to penetrate intact skin.
Indications
Fucidin® ointment is indicated for the treatment of skin infections caused by staphylococci,
streptococci, Coryne -bacterium minutissimum, and other organisms sensitive to sodium fusid ate. The
most important indications being:
Impetigo Boils Carbuncles Paronychia
Infected wounds Sycosis barbae Hidradenitis Erythrasma
Folliculitis
Application
Fucidin® ointment is applied to the affected area 2 –3 times daily, generally for a period of 7 days. It
can be used with or without a covering dressing.
Caution should be observed when applying Fucidin® ointment in the eye region as this preparation
may cause irritation if it gets into the eye.
Special Warning and Precautions of Use
Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical
Fucidin ®. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of
developing antibiotic resistance.
Fucidin® Ointment contains cetyl alcohol and wool fat ( hydrous lanolin ). These excipients may cause
local skin reactions (e.g. contact dermatitis). Fucidin® Ointment contains butylhydroxytoluene (E321)
which may cause local skin reactions (e.g. contact dermatitis) and irrit ation to the eyes and mucous
membranes.
When Fucidin ® ointment is used on the face; ca