Fucidin^® Ointment.

Fucidin^® Ointment contains Sodium Fusidate Ph.Eur.2% .

Excipient: cetyl alcohol

Excipient: lanolin

For full list of excipients, see section 6.1

Ointment for topical administration.

Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts /abrasions.

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

Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

The sodium salt of fusidic acid has been shown to cause conjunctival irritation. The ointment should not be used in or near the eye. 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.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fucidin^® Ointment contains cetyl alcohol and lanolin, which may cause allergic reactions (possibly delayed).

None known.

There is inadequate evidence of safety in human pregnancy. Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effects.

There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of topical Fucidin^® in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk but with topical use the possible amount of drug present is unlikely to affect the infant.

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

Based on combined clinical data for Fucidin^® cream and Fucidin^® ointment, less than 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.

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

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

Not known (cannot be estimated from the available data)

Immune system disorders

Rare

Hypersensitivity

Eye disorders

Rare

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon

Pruritus

Rash including erythematous, maculo-papular and pustular reactions

Contact Dermatitis

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

Not known

Urticaria

Angioedema

Eczema

Periorbital oedema

Overdose is unlikely to occur.

Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin^® ointment is unlikely to cause any harm. The total quantity of fusidic acid (30g Fucidin^® ointment contains 576mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing 10kg. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fucidin^® ointment. The concentration of the excipients is too low to constitute a safety risk.

Fusidic acid is a potent topical antibacterial agent. Fusidic acid and its salts show fat and water solubility and strong surface activity and exhibit unusual ability to penetrate intact skin. Concentrations of 0.03-0.12 microgram/ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.

In vitro studies show that fusidic acid can penetrate intact human skin. 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 pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Cetyl alcohol, lanolin, white soft paraffin, liquid paraffin.

Not applicable.

3 years.

None.

Aluminium tubes of 3 gram, 5 gram, 10 gram, 15 gram, 25 gram and 30 gram.

None.

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

PL 0043/5005R

United Kingdom 24.10.1986.

5 August 2010