Fucidin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium fusidate 250mg; Sodium fusidate 250mg

Available from:

LEO Pharma Limited

INN (International Name):

Sodium fusidate 250 mg

Dosage:

250 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Sodium fusidate 250mg Excipient: Colloidal silicon dioxide Crospovidone Gelatin Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Titanium dioxide Active: Sodium fusidate 250mg Excipient: Colloidal silicon dioxide Crospovidone DL-alpha Tocopheryl acetate Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Titanium dioxide

Units in package:

Aluminium foil, 12x250mg, 12 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Leo Pharma A/S

Therapeutic indications:

Treatment of localised as well as generalised staphylococcal infections (e.g. abscesses, furunculosis, wound infections, pneumonia, peritonitis, osteomyelitis, septicaemia, enteritis and otorhinolaryngeal infections).

Product summary:

Package - Contents - Shelf Life: Aluminium foil, 12x250mg - 12 tablets - 36 months from date of manufacture stored at or below 30°C - Aluminium foil, 12x250mg - 36 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, 12x250mg - 12 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

FUCIDIN
® TABLETS CMI
1
FUCIDIN
® TABLETS
(few-si-din)
_Sodium fusidate 250 mg_
CONSUMER MEDICINE INFORMATION (CMI)
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
IS 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
(seePRODUCT 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-C

Summary of Product characteristics

1 of 7
NEW ZEALAND DATA SHEET
1
FUCIDIN
®
250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSTION
Each tablet contains active ingredient sodium fusidate 250 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet: white, film-coated, ovoid.
4
CLINICAL PARTICULARS
4.1 INDICATIONS
Treatment of localised as well as generalised staphylococcal
infections (e.g. abscesses, furunculosis,
wound infections, pneumonia, peritonitis, osteomyelitis, septicaemia,
enteritis and otorhinolaryngeal
infections).
Cystic fibrosis: Fucidin
®
is useful for elimination of staphylococci from the respiratory tract
of patients
with this condition.
Endocarditis: when the infecting organism has been shown to be
susceptible.
IF BACTERIOLOGICAL DIAGNOSIS REVEALS METHICILLIN-RESISTANT
_STAPHYLOCOCCUS AUREUS,_ THE USE OF FUCIDIN
®
MONOTHERAPY IS NOT APPROPRIATE AND CONCURRENT TREATMENT WITH OTHER
ANTI-STAPHYLOCOCCAL
ANTIBIOTICS IS NECESSARY.
4.2 DOSAGE 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.
Oral tablets
•
For community acquired mild to moderate acute skin and skin structure
infections likely to be caused
by methicillin – sensitive staphylococci e.g. boils, carbuncles,
furuncles, superficial abscesses,
paronychia, superficial wound infections and impetigo.
_Adults_
250mg twice daily
•
For all other indications caused by Staphylococcus aureus.
_Adults_
2 x 250mg three times daily.
_Children_
5 to 12 years: 250mg three times daily.
Over 12 years: as for adults.
2 of 7
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 less sensitive
mutants. In general, full dosage of each
antibiotic has been us