ACIDE FUSIDIQUE ARROW 2 % Cr T/15g

Fusidic acid........................................................................................................................................... 2,000 g

For 100 g of cream.

Excipients with known effect: butylhydroxyanisole (E320), cetyl alcohol and potassium sorbate (E202).

Skin infections due to staphylococcus and streptococcus:

• impetigo and impetiginised dermatoses:

• topical treatment only in localised forms with a small number of lesions,
• adjunctive topical treatment in combination with appropriate systemic antibiotic therapy in more extensive forms,

• disinfection of cutaneous and mucosal microbial carriage sites, in healthy carriers of staphylococci, and after staphylococcal infection, notably furunculosis.

Official recommendations concerning the appropriate use of antibacterial agents should be taken into account.

Dosage

• Topical application with or without a dressing, once or twice daily after cleansing of the infected surface. Avoid application in a thick layer. Limit treatment to one week, as a guide.

• The cream form is more particularly suited to exuding, macerated lesions and skin folds.

• Do not use the ointment form on exuding or macerated lesions, nor in skin folds, nor on leg ulcers.

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

Bacterial resistance of Staphylococcus spp. aureus has been reported with the use of topical fusidic acid. As with all antibiotics, prolonged or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.

Fusidic acid should therefore be used with caution if applied near the eye.

Excipients with known effect

This medicine contains cetyl alcohol and potassium sorbate, which may cause local skin reactions (for example contact dermatitis).

This medicine contains butylhydroxyanisole (E320), which may cause local skin reactions (for example contact dermatitis) or irritation of the eyes and mucous membranes.

No interaction studies have been performed. Interactions with systemically administered pharmaceutical products are considered minimal, as systemic absorption of topical fusidic acid is negligible.

Pregnancy

No effect during pregnancy is expected as systemic exposure to fusidic acid is negligible.

Topical fusidic acid may be used during pregnancy.

Breast-feeding

No effect on breastfed newborns/infants is expected, insofar as the systemic exposure of the breastfeeding woman to fusidic acid is negligible. Topical fusidic acid may be used during breastfeeding, but it is recommended to avoid applying it to the breast.

Fertility

No clinical studies on the effects of topical fusidic acid on fertility have been conducted.

Topical fusidic acid has no or negligible effect on the ability to drive vehicles and use machines.

The estimate of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reports.

According to pooled data obtained in clinical studies including 4 724 patients to whom fusidic acid cream or fusidic acid ointment was administered, the frequency of undesirable effects amounts to 2,3 %.

The most frequently reported undesirable effects are various skin reactions such as pruritus and rash, as well as various reactions limited to the application site, such as pain and irritation; these effects were observed in less than 1 % of patients.

Cases of hypersensitivity and Quincke's oedema have been reported.

Undesirable effects are presented by System Organ Class (SOC) according to the MedDRA classification, and each individual undesirable effect is listed in decreasing order of frequency and severity.

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)

*Various types of rash have been observed, including erythematous, pustular, vesicular, maculopapular, papular and generalised rashes.

Paediatric population

The frequency, nature and severity of adverse effects in children should 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/

Overdose is unlikely.

Pharmacotherapeutic class: local antibiotic therapy, ATC code: D06AX01.

Fusidic acid is an antibiotic with a steroid-like structure, belonging to the fusidane family.

Critical concentrations

The critical concentrations or minimum inhibitory concentration (MIC) breakpoints used to interpret the susceptibility of the bacterial strain are established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for fusidic acid and are as follows:

https://www.ema.europa.eu/documents/other/minimum-inhibitory-concentration-mic-breakpoints_en.xlsx

Spectrum of antibacterial activity

The prevalence of acquired resistance may vary with geography and time for certain species. It is therefore useful to have information on local resistance prevalence, especially for the treatment of severe infections. These data can only provide guidance on the likelihood of susceptibility of a bacterial strain to this antibiotic.

Where the variability of resistance prevalence in France is known for a bacterial species, it is indicated in the table below:

Remark : this spectrum corresponds to that of the systemic forms of fusidic acid. With the local pharmaceutical presentations, the concentrations obtained in situ are much higher than plasma concentrations. Some uncertainties remain regarding the kinetics of the concentrations in situ, the local physicochemical conditions that may alter the activity of the antibiotic, and the stability of the product in situ.

Fusidic acid acts by blocking the protein synthesis mechanisms of bacteria.

Fusidic acid, given its surfactant properties and its both lipophilic and hydrophilic character, penetrates well through the skin and is found in all layers of the cutaneous and subcutaneous tissue.

2 years.

Store at a temperature not exceeding 25°C.

After opening: to be stored for 6 months at a temperature not exceeding 25°C.

No special requirements.