FUCIDIN TABLET 250MG (FILM COATED)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SODIUM FUSIDATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

SODIUM FUSIDATE

Unit dalam pakej:

20 Tablet Tablets; 20Tablet Tablets

Dikeluarkan oleh:

Laboratories Leo

Risalah maklumat

FUCIDIN
®
TABLET
Sodium Fusidate (250mg)
________________________________________________________________________________________________________
________________________________________________________________________________________________________
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Fucidin® tablet is used for
2.
How Fucidin® tablet works
3.
Before you use Fucidin® tablet
4.
How to use Fucidin® tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Fucidin®
tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT FUCIDIN
®
TABLET_ _IS USED FOR
Fucidin® tablet contains sodium fusidate.
It is a type of antibiotic.
Fucidin®
tablet
is
indicated
for
the
treatment
of
infections
caused
by
susceptible
organisms,
especially
staphylococci, for example:
• Infections of the skin and wounds
•
Infections
of
the
blood
such
as
septicaemia
• Infections of the bone and heart tissue
•
Infections
of
the
lungs
such
as
pneumonia
• Infections connected with the condition
cystic
fibrosis,
a
genetic
disease
that
affects mucus and sweat glands, causing
mucus to become thick and sticky.
•
Inflammation of the endocardium, the
inner layer of the heart.
HOW _FUCIDIN_
_® _
_TABLET _WORKS
Fucidin
®
tablet
_ _
work by killing germs
(bacteria) that cause infections.
BEFORE YOU USE FUCIDIN
®
TABLET_ _
-
_When you must not use it _
_ _
Do not take Fucidin
®
tablet
_ _

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:
_Product _
_Description _
of
this
leaflet.

If
you
are
taking
statins
(medicines
to
lower
blood
cholesterol).
_Pregnancy and lactation _
_ _
Please ask your doctor or pharmacist for
advice before taking Fucidin
®
tablet:

If you are pregnant, or think you
are pregnant

If you are breast-feeding.
Te

Ciri produk

Fucidin ®
Antistaphylococcal Antibiotic
Brand name
Fucidin®
Active ingredients and strength
Tablets: Sodium fusidate 250 mg
Presentation
The tablet is an approximately 7.8 x 16.0 mm white to off -white greyish marbled film -coated oval
biconvex tablet without embossing.
Therapeutic properties
Properties: Fusidic acid is an antibiotic which mode of action is as inhibitor of the bacterial protein
synthesis resulting in a bacteri cidal effect. Fusidic acid has a powerful antibacterial activity against a
number of gram -positive microorganisms. Staphylococci, including the strains resistant to penicillin,
methicillin or other antibiotics, are particularly susceptible to fusidic acid. Fusidic acid shows no
cross -resistance to any other antibiotic agent used in clinical practice. Fucidin® tablets has an
unusually good ability to penetrate tissue and is widely distributed in the organism. It is of great
clinical importance that Fucidin® tablets provides high concentrations not only in areas well supplied
with blood, but also in relatively avascular tissue. Concentrations exceeding the M.I.C. for
Staphylococcus aureus (0.03 -0.16 mcg/ml) have been found in pus, sputum, soft tissue, heart ti ssue,
bone tissue, synovial fluid, sequestra, burn crusts, brain abscesses, and intraocularly. Fusidic acid is
metabolized in the liver and mainly excreted through the bile, little or none being excreted through
the urine.
Fucidin® tablets are generally atoxic and shows no cross -hypersensitivity to other antibiotics in
clinical use which is why Fucidin® tablets also can be used in many cases where other antibiotics are
contraindicated, e.g. in patients allergic to penicillin or other antibiotics.
In severe or deep -seated infections and when prolonged therapy is required, Fucidin® tablets should
generally be given concurrently with other antistaphylococcal antibiotic therapy to minimize the risk
of resistance development. Fucidin® tablets may be combin ed with penicillinase -stable penicillins,
cephalosporins, erythromycin,