FUSIDIC ACID Cream Ref.[6873] Active ingredients: Fusidic acid

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.

Fusidic acid should not be used in infections caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa, see section 5.1.

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

When Fusidic acid 20 mg/g cream is used on the face, care should be taken to avoid the eyes, because fusidic acid can cause irritation of the conjunctiva.

Fusidic acid 20 mg/g 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.

No interaction studies have been performed.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical fusidic acid 20mg/g cream can be used during pregnancy.

Breast-feeding

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of the breast-feeding woman is negligible. Topical Fusidic acid 20mg/g cream can be used during breast-feeding but it is recommended to avoid applying topical Fusidic acid 20mg/g cream on the breast.

Fertility

There are no clinical studies with topical Fusidic acid 20mg/g cream regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible.

Fusidic acid 20mg/g cream has no or negligible influence on the ability to drive and use machines.

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 4754 patients who received Fusidic acid 20mg/g cream or fusidic acid 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 according to the following frequency convention:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <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: Dermatitis (incl. contact dermatitis, eczema) Rash*

Pruritus, Erythema

Rare: Angioedema, Urticaria, Blister

General disorders and administration site conditions

Uncommon: Application site pain (incl. skin burning sensation), Application site irritation

* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.

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 reaction 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 Website: www.mhra.gov.uk/yellowcard.

Not applicable.