Fucidin 250mg/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fusidic acid anhydrous

Available from:

Leo Laboratories Limited

ATC code:

J01XC; J01XC01

INN (International Name):

Fusidic acid anhydrous

Dosage:

250 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Steroid antibacterials; fusidic acid

Authorization status:

Not marketed

Authorization date:

1977-04-01

Patient Information leaflet

140 mm
420 mm
75 mm
20 mm
4 m
m
INS022-00
WHAT IS IN THIS LEAFLET
1.What Fucidin
®
Suspension is and what
it is used for
2.What you need to know before you take
Fucidin
®
Suspension
3.How to take Fucidin
®
Suspension
4.Possible side effects
5.How to store Fucidin
®
Suspension
6.Contents of the pack and other
information
1. WHAT FUCIDIN
®
SUSPENSION IS AND
WHAT IT IS USED FOR
Fucidin Suspension contains fusidic acid.
It is a type of antibiotic.
Fucidin Suspension works by killing
germs (bacteria) that cause infections.
Fucidin Suspension is used to treat
infections such as those caused by a
bacteria called
Staphylococcus.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FUCIDIN
®
SUSPENSION
DO NOT TAKE FUCIDIN SUSPENSION:
• If you are allergic to fusidic acid or any
of the other ingredients in this medicine
(listed in section 6).
• If you are taking statins, medicines to
lower blood cholesterol.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Fucidin Suspension if:
• You are taking statins (medicines to
lower blood cholesterol).
• You have problems with your liver or if
you have recently been jaundiced (skin
and whites of eyes appear yellow).
• You have a blockage or a problem with
your bile duct, e.g. gallstones.
• You are taking some medicines called
HIV-Protease Inhibitors used to treat the
HIV virus.
When you are taking Fucidin Suspension
your doctor may take regular blood tests
if you are taking other medicines which
affect the liver.
If you are concerned that your treatment
is not as effective as it should be, tell your
doctor. As with any antibiotic treatment,
long term or repeated use may increase
the risk of developing antibiotic resistance.
If you have been told by your doctor that
you have intolerance to some sugars,
contact your doctor before taking this
medicinal product.
A few cases have been reported of severe
skin reactions, which may develop into
potentially life-threatening skin reactions if
they are not treated. Contact your doctor
immediately if you experience

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 250mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid.
Each 5 ml of suspension contains 250 mg of anhydrous fusidic acid (as
hemihydrate).
Excipients with known effect
Glucose liquid 250 mg/1 ml suspension
Sorbitol (E420) 100 mg/1 ml suspension
Sodium 1.6 mg/1 ml suspension
Orange dry flavour (containing sucrose) 400 mcg/1 ml suspension.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
Cream coloured suspension with odour of banana.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of systemic infections due to micro-organisms
sensitive to this anti-infective, such as Staphylococci.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult dose: The usual total daily dose is 1500-2000 mg (30 – 40 ml)
each day in 3 equally divided doses.
_Paediatric population_
Children: The usual daily dose is 20-50 mg/kg (0.4 ml/kg – 1 ml/kg)
each day in 3 equally divided doses.
Method of administration
For oral administration. The suspension should be shaken well before
use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Concomitant treatment with statins (HMG-CoA reductase inhibitors).
(See section 4.4, 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This medicinal product contains 1.6 mg sodium per ml suspension. To be
taken into consideration by patients on a
controlled sodium diet.
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not
be co-administered, (see section 4.3). There
have been reports of rhabdomyolysis (including fatalities) in patients
receiving this combination.
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