SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Fucidin Ointment.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Fucidin Ointment contains Sodium Fusidate Ph.Eur.2%

Excipient: butylhydroxytoluene (E321)

Excipient: cetyl alcohol Excipient: lanolin (wool fat)

For the full list of excipients, see section 6.1

3.    PHARMACEUTICAL FORM

Ointment 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

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Fucidin. 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 hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin Ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g contact dermatitis) or irritation to the eyes and mucous membranes.

When Fucidin ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6 Fertility, pregnancy and lactation

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 breastfed new-bom/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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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 drug reactions during treatment are various skin reactions such as pruritus and rash, followed by 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 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 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 (incl. 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 (incl. 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.

4.9 Overdose

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.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

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.

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. Pre-clinical 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

Cetyl alcohol

Lanolin (wool fat)

White soft paraffin Liquid paraffin,

All-rac-a-tocopherol Butylhydroxytoluene (E321)

Incompatibilities

Not applicable.

6.3    Shelf life

Unopened container: 3 years.

After first opening of container: 3 months

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5.    Nature and Content of Container

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

6.6    Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

LEO Laboratories Limited

Horizon

Honey Lane

Hurley

Maidenhead

Berkshire

SL6 6RJ

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00043/5005R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24.10.1986.

10 DATE OF REVISION OF THE TEXT

13/08/2014