LEO Pharma

Fucidin^® 250 mg tablets

Each tablet contains 250 mg of sodium fusidate.

For a full list of excipients, see 6.1.

Film-coated tablet.

White to off-white greyish marbled film-coated oval biconvex tablets without embossing.

In the treatment of infections due to micro-organisms sensitive to this anti-infective, such as Staphylococci.

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.

Children:

The usual total daily dose is 20 to 50 mg/kg in divided doses.

Known hypersensitivity to sodium fusidate/fusidic acid or to any of the excipients

Concomitant treatment with statins, see section 4.5.

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

Fucidin^® administered systemically should be given with caution and liver function should be monitored if used in patients with impaired liver function, in patients given potentially hepato-toxic drugs, and if used in patients with biliary tract obstruction or in patients on concurrent drugs with similar excretion pathway.

Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if Fucidin^® is administered systemically to patients with impaired transport and metabolism of bilirubin. Particular care should be taken in neonates (especially if premature) due to the theoretical risk of kernicterus.

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

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.

HMG-CoA reductase inhibitors

Co-administration of Fucidin^® systemically and HMG-CoA reductase inhibitors such as statins causes increased plasma concentrations of both agents resulting in an elevation of creatine kinase level (rhabdomyolysis), muscle weakness and pain. Concomitant treatment with statins is therefore contraindicated, see section 4.3

CYP-3A4 biotransformed drugs

Specific pathways of fusidic acid metabolism in the liver are not known, however, an interaction between fusidic acid and drugs being CYP-3A4 biotransformed can be suspected. The mechanism of this interaction is presumed to be a mutual inhibition of metabolism. The use of Fucidin^® systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.

Oral anticoagulants

Fucidin^® administered systemically and concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may increase the plasma concentration of these agents enhancing the anticoagulant effect. Adjustment of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation. The mechanism of this suspected interaction remains unknown.

HIV protease inhibitors

Co-administration of Fucidin^® systemically and HIV protease inhibitors such as Ritonavir and Saquinavir causes increased plasma concentrations of both agents which may result in hepatotoxicity.

Ciclosporin

Co-administration of Fucidin^® systemically and Ciclosporin has been reported to cause increased plasma concentration of Ciclosporin.

Pregnancy

There are no adequate data from the use of fusidic acid administered systemically in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Fucidin^® administered systemically should not be used during pregnancy unless clearly necessary.

Lactation

Fusidic acid is excreted in breast milk in negligible amounts. The clinical relevance of this is unknown. Caution is required when Fucidin^® is used in mothers who wish to breast feed.

Fusidic acid has no or negligible influence on the ability to drive and to use machines.

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

Based on clinical data in the indication skin and subcutaneous tissue infection, undesirable effects occurred in approximately 15% of patients receiving Fucidin^® film coated tablets.

The most frequently reported undesirable effects to Fucidin^® administered orally are gastrointestinal disorders and symptoms of general disorders. Gastrointestinal system disorders are dose dependant. Various skin reactions, reversible jaundice, haematological disorders and generalised hypersensitivity reactions have been reported.

Blood and lymphatic system disorders

Very rare:

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. This has been observed especially in case of treatment with duration of more than 15 days and is reversible upon drug withdrawal.

Immune system disorders

Rare:

Allergic reaction

Very rare:

Anaphylactic reaction

Metabolism and nutrition disorders

Uncommon:

Anorexia

Nervous system disorders

Uncommon:

Drowsiness

Gastrointestinal disorders

Common:

Diarrhoea

Vomiting

Abdominal pain

Dyspepsia

Nausea

Hepatobiliary disorders

Rare:

Hyperbilirubinaemia

Jaundice

Hepatic enzymes increased

Very rare:

Hepatorenal syndrome

Liver function abnormalities like hyperbilirubinaemia (with or without jaundice) and increase in hepatic enzymes such as alkaline phophatase and transaminases should lead to withdrawal of treatment. Return of laboratory parameters to normal is usual and generally rapid. Hepatorenal syndrome, cf. 'Renal disorders'.

Skin and subcutaneous tissue disorders

Uncommon:

Rash*

Urticaria

Pruritus

*Rash includes various types of rash reactions such as erythematous, maculo-papular and pustular.

Renal and urinary disorders

Very rare:

Renal failure

Acute renal failure has been described in patients with jaundice, in particular in the presence of other factors predisposing for renal failure.

General disorders and application site conditions

Uncommon:

Asthenia

Fatigue

Malaise

Musculoskeletal, connective tissue and bone disorders

Frequency not known:

Rhabdomyolysis (examples of signs and symptoms are: muscle weakness, swelling and pain, dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia), see section 4.5.

Acute symptoms of overdose include gastrointestinal disturbances and possible effect on liver function. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid.

Pharmacotherapeutic group: General anti-infective for systemic use

ATC code: J01XC01

Fucidin^® exerts powerful activity against a number of gram-positive organisms. Staphylococci including the strains resistant to penicillin and other antibiotics are particularly susceptible to Fucidin^®. Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus.

Fucidin^® readily penetrates tissue. Bactericidal levels have been assayed in bone and necrotic tissue. Blood levels are cumulative, reaching concentrations of 50-100 mcg/ml after oral administration of 1.5 g daily for three to four days. Fucidin^® is excreted mainly in the bile, little or none being excreted in the urine.

Animal studies have indicated that Fucidin^® is practically atoxic.

Core:

microcrystalline cellulose

crospovidone

lactose monohydrate

magnesium stearate

colloidal anhydrous silica

talc

all-rac- α-tocopherol

Filmcoating:

hypromellose

titanium dioxide

Not applicable

3 years in blister packs.

No special precautions for storage.

Aluminium/aluminium blister packs and strip blister packs of 10 x 10 tablets, 10 tablets, 4 tablets (FMS) and 2 tablets (FMS)

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

LEO Laboratories Limited, Cashel Road, Dublin 12

PA 46/4/14

Date of first authorisation: 13 March 1990

Date of last renewal: 13 March 2005

June 2009

Prescription only medicine