Fucidin Cream

1. Name Of The Medicinal Product

Fucidin^® Cream

2. Qualitative And Quantitative Composition

Fucidin^® Cream contains fusidic acid Ph.Eur. 2%.

Excipient: butylhydroxyanisole

Excipient: cetyl alcohol

Excipient: potassium sorbate

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Cream for topical administration

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

Adults and Children:

Uncovered lesions - apply gently three or four times daily.

Covered lesions - less frequent applications may be adequate.

4.3 Contraindications

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

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

4.4 Special Warnings And Precautions For Use

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.

Fusidic acid does not appear to cause conjunctival irritation in experimental animals. Caution should still be exercised, however, when Fucidin Cream is used near the eyes.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

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 effect. 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.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

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

Common

Uncommon

Rare

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

4.9 Overdose

Overdose is unlikely to occur

Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin^® cream is unlikely to cause any harm. The total quantity of fusidic acid (30g Fucidin^® cream contains 600mg 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 ^® cream. The concentration of the excipients is too low to constitute a safety risk.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Fusidic acid is a potent 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 mcg fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated hydroxyanisole, cetanol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin, purified water.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Aluminium tubes of 3.5 gram, 5 gram, 10 gram, 15 gram, 25 gram and 30 gram.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

03/03/2009.

10. Date Of Revision Of The Text

5 August 2010