Fucidin Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT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
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® 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.
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-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.
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
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® 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
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 and 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
None
7 MARKETING AUTHORISATION HOLDER
LEO Laboratories Limited
Horizon
Honey Lane
Hurley
Maidenhead
Berkshire
SL6 6RJ
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00043/0065
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
10 DATE OF REVISION OF THE TEXT
02/12/2013