FUCIDIN 20 MG / G CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Fucidin 20 mg/g Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Fucidin cream contains fusidic acid Ph.Eur. 20 mg/g.

Excipients with known effect

Butylhydroxyanisole (E320)

Cetyl alcohol

Potassium sorbate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream for topical administration.

A white to off-white cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Fucidin 20 mg/g cream is 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

Posology

Adults and Paediatric population

Uncovered lesions – apply gently three or four times daily.

Covered lesions – less frequent applications may be adequate.

Method of administration

Cutaneous use.

4.3 Contraindications

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

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 cream contains butylhydroxya­nisole, cetyl alcohol and potassium sorbate. 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.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

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

Pregnancy

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

Breast-feeding

No effects on the breast-fed new-born/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.

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.

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 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

(>1/1,000 and <1/100)

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 < 10kg. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fucidin® cream. The concentration of the excipients is too low to constitute a safety risk.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other antibiotics for topical use, ATC code: D06AX01

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

Butylhydroxyanisole (E320)

Cetanol

Glycerol

Liquid paraffin

Potassium sorbate

Polysorbate 60

White soft paraffin

All- rac-a-tocopherol

Hydrochloric acid

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 g, 5 g, 10 g, 15 g, 25 g and 30 g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

LEO Laboratories Limited

Horizon

Honey Lane

Hurley

Maidenhead

Berkshire

SL6 6RJ

UK