Special Warning : אזהרת שימוש

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 severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.


In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.


Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin Leo therapy but are usually reversible on discontinuation of the drug.


Systemic Fusidin Leo should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction or in patients taking potentially hepatotoxic drugs. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors (see section 4.5). Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin Leo is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus.


Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.


Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine due to the content of lactose.


This medicinal product contains 11mg sodium per tablet. This should be taken into consideration by patients on a controlled sodium diet.

Effects on Driving

4.7 Effects on ability to drive and use machines
Fucidin Leo has no or negligible influence on the ability to drive or to use machines.