els have been detected in the breast milk. Caution is therefore required when Fucidin® is used in mothers who wish to breast feed.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Based on clinical trial data, undesirable effects occurred in approximately 15% of patients receiving Fucidin® orally. The most frequently reported undesirable effects to Fucidin® administered orally are dose dependent gastrointestinal disorders. Various skin reactions, reversible jaundice, haematological disorders and generalised hypersensitivity reactions have been reported.
Undesirable effects are listed below, by MedDRA System Organ Class, in decreasing order of frequency within each class. Where frequencies are given, these are based on the clinical trial data, using the stated frequency classification. Where the term 'Not known' is given, these effects are derived from spontaneous reports.
Frequency classification:
Very common
>1/10
Common
>1/100 and <1/10
Uncommon
>1/1,000 and <1/100
Rare
>1/10,000 and <1/1,000
Very rare
<1/10,000
• Blood and lymphatic system disorders
Not known: Pancytopenia
Leukopenia*
Thrombocytopenia
Anaemia
*Haematological disorders affecting the white cell line (neutropenia, granulocytopenia, agranulocytosis) and, more rarely, disorders affecting the other two cell lines have been reported, either as isolated events or associated. These abnormalities have been observed especially with treatment of more than 15 days and are reversible upon drug withdrawal.
• Immune system disorders
Rare: Allergic reaction
Not known: Anaphylactic reaction
• Metabolism and nutrition disorders
Uncommon: Anorexia
• Nervous system disorders
Common: Drowsiness
Dizziness
Uncommon: Headache
• Gastrointestinal system disorders
Common: Diarrhoea
Vomiting
Abdominal Pain
Dyspepsia
Nausea
• Hepatobiliary disorders
Not known:Hyperbilirubinaemia
Jaundice (see section 4.4)
Hepatic enzymes increased (see section 4.4)
Hepatorenal syndrome
Liver function abnormalities like hyperbilirubinaemia with or without jaundice and increase in hepatic enzymes such as alkaline phosphatase and transaminases should lead to withdrawal of treatment. Return of laboratory parameters to normal is usual and generally rapid.
Cholestasis
• Skin and subcutaneous tissue disorders
Uncommon: Rash*
Urticaria
Pruritus
*Rash includes various types of reactions such as erythematous, maculo-papular and pustular.
• Musculoskeletal and connective tissue disorders
Not known: Rhabdomyolysis (see Section 4.4 and 4.5)
Rhabdomyolysis may be fatal. Examples of signs and symptoms are: muscle weakness, muscle swelling and muscle pain, dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia.
• Renal and urinary disorders
Not known: Renal failure
Acute renal failure has been described in patients with jaundice, in particular in the presence of other factors predisposing to renal failure.
• General disorders and admin
