LEO Pharma

Fucidin^® 250 mg/5 ml Oral Suspension

Fusidic acid.

Each 5 ml contains 250 mg of anhydrous fusidic acid (as hemihydrate).

Excipients: contains glucose liquid 250 mg/ml, sorbitol (E420) 100 mg/ml, sodium 2 mg/ml and orange dry flavour (containing sucrose).

For a full list of excipients, see section 6.1

Oral suspension.

White to off-white with banana flavour.

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

Adult dose: The usual total daily dose is 1500-2000 mg (30 – 40ml) each day in three equally divided doses.

Children: The usual daily dose is 20-50 mg/kg (0.4ml/kg – 1 ml/kg) each day in three equally divided doses.

Known hypersensitivity to fusidic acid / sodium fusidate 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^® suspension should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction, 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^® suspension 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.

Fucidin^® Suspension contains liquid glucose, sorbitol and orange dry flavour (theoretically which contains sucrose); patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase–isomaltase insufficiency should not take this medicine.

Fucidin^® Suspension contains 2 mg sodium per ml; this should be taken into consideration by patients on a controlled sodium diet.

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 (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 Fucidin^® metabolism in the liver are not known, however, an interaction between Fucidin^® 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 action 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 is 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 therefore 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.

Based on clinical data, undesirable effects occurred in approximately 15% of patients receiving Fucidin^® orally.

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

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Blood and lymphatic system disorders

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

Immune system disorders

Rare (1/10,000 and <1/1,000):

Allergic reaction

Frequency not known:

Anaphylactic reaction

Metabolism and nutrition disorders

Uncommon (1/1,000 and <1/100:

Anorexia

Nervous system disorders

Common (1/100 and <1/10):

Drowsiness/dizziness

Gastrointestinal disorders

Common (1/100 and <1/10):

Diarrhoea

Vomiting

Abdominal pain

Dyspepsia

Nausea

Hepatobiliary disorders

Frequency not known:

Hyperbilirubinaemia

Jaundice

Hepatic enzymes increased

Hepatorenal syndrome

Cholestasis

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.

Hepatorenal syndrome, cf. 'Renal disorders'.

Skin and subcutaneous tissue disorders

Uncommon (1/1,000 and <1/100):

Rash*

Urticaria

Pruritus

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

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.

Renal and urinary disorders

Frequency not known:

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 (1/1,000 and <1/100):

Asthenia

Fatigue

Malaise

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 the central nervous system when the meninges are inflamed and is widely distributed in the body. 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.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other areas of the SPC.

acesulfame potassium

banana flavour

citric acid monohydrate

disodium phosphate dihydrate (E339)

liquid glucose

hyetellose

methylcellulose

orange dry flavour (contains sucrose)

sodium benzoate (E211)

sorbitol (E420)

purified water.

This medicinal product must not be mixed with other medicinal products.

Unopened: 3 years

After first opening: 1 month

This medicinal product does not require any special storage conditions.

Amber glass bottle with white plastic screw cap supplied with measuring cup.

Each bottle contains 50 ml of suspension.

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

LEO Laboratories Limited, Cashel Road, Dublin 12.

PA 46/4/10

1^st April 1977/13^th March 2010

August 2011

Prescription only medicine