Uncommon: Asthenia

Fatigue

Malaise
4.9 Overdose
Acute symptoms of overdose include gastrointestinal disturbances and possible effects on liver function. Treatment should be restricted to symptomatic and supportive measures. Dialysis will not increase the clearance of fusidic acid.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Fusidic acid and its salts are potent anti-staphylococcal agents with unusual ability to penetrate tissue. Bactericidal levels have been assayed in bone and necrotic tissue. Concentrations of 0.03 - 0.12 micrograms/ml inhibit nearly all strains of Staphylococcus aureus. Fusidic acid is active against Staphylococcus epidermidis and methicillin resistant staphylococci.
5.2 Pharmacokinetic properties
Blood levels are cumulative, reaching concentrations of 20-35 micrograms/ml after oral administration of 250mg twice daily for seven days and 50-100 micrograms/ml after oral administration of 500mg three times daily for three to four days.

Fucidin® is excreted mainly in the bile, little or none being excreted in the urine.

In severe or deep-seated infections and when prolonged therapy may be required, Fucidin® should generally be given concurrently with other anti-staphylococcal antibiotic therapy.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Cellulose microcrystalline, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, silica, all-rac-α-tocopherol, talc, titanium dioxide.
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Aluminium-aluminium blister and strip blister packs of 2, 4 and 10 and 10 x 10 tablets.
6.6 Special precautions for disposal and other handling
None.
7. Marketing authorisation holder
LEO Laboratories Limited,

Horizon

Honey Lane

Hurley

Maidenhead

Berkshire

SL6 6RJ

UK
8. Marketing authorisation number(s)
PL 00043/5000R
9. Date of first authorisation/renewal of the authorisation
4.6.87 (after review).
10. Date of revision of the text
October 2013