FUCIDIN sodium fusidate 250 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium fusidate, Quantity: 250 mg

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Sodium fusidate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; titanium dioxide; lactose monohydrate; crospovidone; hypromellose; microcrystalline cellulose; purified talc; magnesium stearate; dl-alpha-tocopherol

Administration route:

Oral

Units in package:

24 tablets, 36 tablets, 12 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of localised, as well as generalised, staphylococcal infections caused by susceptible organisms. In severe infections, deep-seated infections, infections due to methicillin-resistant Staphylococci or when prolonged therapy may be required, Fucidin must be given concurrently with other anti-staphylococcal antibiotic therapy.

Product summary:

Visual Identification: Approximately 7.8 x 16.0 mm white to off-white greyish marbled film coated oval biconvex tablets without embossing.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-01-31

Patient Information leaflet

FUCIDIN

TABLETS
1
FUCIDIN
® TABLETS
_Sodium fusidate 250 mg_
_ _ (few-si-din)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Fucidin
®
Tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Fucidin
®
Tablets against the benefits the
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING EITHER OF THESE MEDICINES,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT FUCIDIN
® TABLETS
ARE USED FOR
Fucidin
®
Tablets contain an
antibiotic which kills certain bacteria
which can cause serious illness.
Fucidin
®
Tablets are active against
Staphylococci or “Staph”, which
can cause severe infections.
Infection may occur in different
parts of the body, for example, the
lung, bone, blood, heart, joints,
eyes, skin and wounds.
This medicine may be used with
other antibiotics to treat infections.
Fucidin
®
Tablets will not work
against infections caused by
viruses, such as cold or flu, and
certain other bacteria.
This medicine is available only with
a doctor’s prescription.
Your doctor may have prescribed
Fucidin
®
Tablets for another
reason. Ask your doctor why
Fucidin
®
Tablets has been
prescribed for you.
There
is
no
evidence
that
this
medicine is addictive.
BEFORE YOU TAKE
FUCIDIN
® TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
sodium fusidate or fusidic acid
•
any of the ingredients listed at
the end of this leaflet (see
PRODUCT DESCRIPTION).
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING CERTAIN MEDICINES FOR
CHOLESTEROL LOWERING CALLED
STATINS OR HMG-COA R

Summary of Product characteristics

Fucidin Tablets
AUSTRALIAN PRODUCT INFORMATION
– FUCIDIN
® TABLETS (SODIUM
FUSIDATE)
1
NAME OF THE MEDICINE
Sodium fusidate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucidin
®
Tablets contain sodium fusidate 250mg.
Excipients with known effect
lactose monohydrate
sugars
galactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Fucidin
®
Tablets are approximately 7.8 x 16.0 mm white to off-white greyish
marble film
coated oval biconvex tablets without embossing.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of localised, as well as generalised, staphylococcal
infections caused by
susceptible organisms.
In severe infections, deep-seated infections, infections due to
methicillin-resistant
Staphylococci or when prolonged therapy may be required, Fucidin
®
must be given
concurrently with other anti-staphylococcal antibiotic therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Fucidin
®
tablets should be taken without a meal to avoid a reduction in the
extent and rate of
absorption of Fucidin
®
by a concomitant meal.
In severe infections, deep-seated infections, infections due to
methicillin-resistant
Staphylococci or when prolonged therapy may be required, Fucidin
®
must be given
concurrently with other anti-staphylococcal antibiotic therapy. Such
combinations may
produce enhanced activity, broaden the antibacterial spectrum and
minimise the risk of the
development of resistance to fusidic acid and its salt. In general,
full dosage of each
antibiotic should be used and in very severe cases, the dosage of
Fucidin
®
may also be
doubled.
The average duration of treatment is 5 – 10 days although more
severe infection may require
a longer treatment period.
eDoc-000796173 - Version
3. 0
Fucidin Tablets
Dosage in Hepatic Insufficiency:
Dosage reduction may be necessary in patients with hepatic impairment,
since the active
ingredient is cleared from the blood via hepatic metabolism.
For community-acquired mild to moderate acute skin and skin-structure
infectio