FUCIDIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM FUSIDATE

Available from:

DEXCEL LTD, ISRAEL

ATC code:

J01XC01

Pharmaceutical form:

TABLETS

Composition:

SODIUM FUSIDATE 250 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

LEO PHARMA A/S , DENMARK

Therapeutic group:

FUSIDIC ACID

Therapeutic area:

FUSIDIC ACID

Therapeutic indications:

For the treatment of infections caused by Staphylococcus.

Authorization date:

2021-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fucidin LEO tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of sodium fusidate.
Excipient with known effect:
Each tablet contains lactose monohydrate 71.9 mg.
Each tablet contains sodium 11 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white greyish marbled film-coated oval biconvex tablet
without embossing.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of infections caused by Staphylococcus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults only:
The usual total daily dose is 1500 mg in divided doses.
In severe infections doses may be doubled or appropriate combined
therapy may be used.
Since fusidic acid is excreted in the bile, no dosage modifications
are needed in renal impairment.
The dosage in patients undergoing haemodialysis needs no adjustment as
fusidic acid is not
significantly dialysed.
_Paediatric population_
Children:
The usual total daily dose is 20 to 50 mg/kg in divided doses.
Method of administration
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin Leo must
not be co-administered.
There have been reports of rhabdomyolysis (including fatalities) in
patients receiving this combination
(see section 4.5).
In patients where the use of systemic Fucidin is considered essential,
statin
treatment should be discontinued throughout the duration of treatment
with systemic Fucidin Leo. The
patient should be advised to seek medical advice immediately if they
experience any symptoms of
muscle weakness, pain or tenderness. Statin therapy may be
re-introduced seven days after the last
dose of systemic Fucidin Leo.
In exceptional circumstances, where prolonged systemic Fucidin is
needed e.g. for the treatment of sever