Fucidin Cream *

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

Posology

Apply three to four times daily or as required.

Less frequent application may be adequate for covered lesions.

Method of administration

Cutaneous use

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Fucidin cream contains butylhydroxyanisole, potassium sorbate and cetyl alcohol. These excipients may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes. Fucidin cream should therefore be used with care when applied in the proximity of the eyes.

No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin is negligible.

Fertility

There are no clinical studies with topical Fucidin regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically-applied fusidic acid/sodium fusidate is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical Fucidin can be used during pregnancy.

Breast-feeding

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fucidin can be used during breast-feeding but it is recommended to avoid applying topical Fucidin on the breast.

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

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.

Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.

Hypersensitivity and angioedema have been reported.

Undesirable effects are listed by the MedDRA system Organ Class (SOC) and the individual undesirable effects are listed, starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

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

Immune system disorders

Rare (≥1/10,000 and <1/1,000):

Hypersensitivity

Eye disorders

Rare (≥1/10,000 and <1/1,000):

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 and <1/100):

Dermatitis (including dermatitis contact, eczema)

Rash*

Pruritus

Erythema

* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.

Rare (≥ 1/10,000 and < 1/1,000):

Angioedema

Urticaria

Blister

General disorders and administration site conditions

Uncommon (≥1/1,000 and <1/100):

Application site pain (including skin burning sensation)

Application site irritation

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

Overdose is unlikely 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.

No special requirements for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.