LEO Pharma

Fucidin^® 20 mg/g Cream

Each gram of cream contains 20 mg fusidic acid.

Excipients: Contains Butylhydroxyanisole (E320) 0.04 mg/g, Potassium Sorbate 2.7 mg/g and cetyl alcohol 111 mg/g

For a full list of excipients, see section 6.1

Cream

A white cream.

In the topical treatment of infections due to micro-organisms sensitive to this anti-infective, in particular Staphylococcus aureus.

Apply three to four times daily or as required.

Less frequent application may be adequate for covered lesions.

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

Fucidin^® cream contains butylhydroxyanisole, potassium sorbate and cetyl alcohol which may cause local allergic skin reactions (e.g. contact dermatitis). In addition, butylhydroxyanisole may cause irritation to the eyes and the mucous membranes.

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

None known

Pregnancy:

For fusidic acid/sodium fusidate no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Lactation:

No effect on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fucidin^®cream can be used during breast-feeding.

Fucidin^® administered topically has no or negligible influence on the ability to drive or to use machines.

Based on combined clinical data for Fucidin^® cream and Fucidin^® ointment, approximately 5% of patients can be expected to experience an undesirable effect.

The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.

Allergic reactions and contact dermatitis have been reported.

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

Immune system disorders

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

Allergic reaction

Eye Disorders

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

Conjunctival irritation

Skin and subcutaneous tissue disorders

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

Rash*

Irritation at site of application (incl. pain, stinging, burning and erythema)

Pruritus

Contact Dermatitis

*Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported.

Frequency unknown:

Urticaria

Angioneurotic oedema

Eczema

Periorbital oedema

Overdose is unlikey to occur.

ATC code: D06AX01

Fucidin^® Cream contains fusidic acid a potent topical antibacterial. Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin^® is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.

There are no data which define the pharmacokinetics of Fucidin^® Cream, following topical administration in man.

However, in vitro studies show that fusidic acid can penetrate intact human skin in concentrations well above the MIC-values of susceptible organisms. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.

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

butylhydroxyanisole (E320)

cetyl alcohol

glycerol

liquid paraffin

polysorbate 60

potassium sorbate

purified water

white soft paraffin

all-rac-α-tocopherol

hydrochloric acid

Not applicable.

3 years

After first opening: 28 days

Do not store above 30°C.

Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap.

Contents: 5 g, 15 g or 30 g cream.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

LEO Laboratories Limited, Cashel Road, Dublin 12

PA 46/4/12

Date of first authorisation: 13 October 1980

Date of last renewal: 13 October 2010

July 2011

Product subject to prescription which may not be renewed (A)