ACIDE FUSIDIQUE SANDOZ 2 % Cr T/15g

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

For 100 g of cream.

Excipients with known effect: butylhydroxyanisole (E 320), cetyl alcohol and potassium sorbate.

Skin infections due to staphylococcus and streptococcus:

• impetigo and impetiginised dermatoses:
  • by topical treatment only in localised forms with a small number of lesions,
  • as adjunctive topical treatment in combination with appropriate systemic antibiotic therapy in the most 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 applications with or without a dressing, once or twice a day 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 weeping, macerated lesions and skin folds.

Do not use the ointment form on weeping 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 aureus has been reported with the use of FUSIDIC ACID SANDOZ by topical route. As with all antibiotics, prolonged or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.

This medicine contains cetyl alcohol and potassium sorbate and may cause local skin reactions (eczema).

This medicine contains butylhydroxyanisole (E 320) and may cause local skin reactions (eczema) or irritation of the eyes and mucous membranes.

FUSIDIC ACID SANDOZ should therefore be used with caution if applied near the eye.

No interaction studies have been performed. Interactions with pharmaceutical products administered systemically are considered minimal, as systemic absorption of FUSIDIC ACID SANDOZ by topical route is negligible.

Pregnancy

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

FUSIDIC ACID SANDOZ by topical route may be used during pregnancy.

Breast-feeding

No effect on breastfed newborns/infants is expected since the systemic exposure of the breastfeeding woman to fusidic acid is negligible. ACIDE FUSIDIQUE SANDOZ for topical use may be used during breastfeeding, but it is recommended to avoid application on the breast.

Fertility

No clinical studies on the effects of ACIDE FUSIDIQUE SANDOZ for topical use on fertility have been conducted.

ACIDE FUSIDIQUE SANDOZ for topical use has no or negligible effect on the ability to drive vehicles and use machines.

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

Based on pooled data obtained from clinical studies including 4 724 patients who were administered fusidic acid cream or fusidic acid ointment, the frequency of adverse effects amounts to 2,3 %.

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

Cases of hypersensitivity and Quincke's edema 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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-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.

ANTIBACTERIAL ACTIVITY SPECTRUM

Critical concentrations separate susceptible strains from strains of intermediate susceptibility, and the latter from resistant ones:

S ≤ 2 mg/l and R > 16 mg/l

The prevalence of acquired resistance can vary according to 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 probabilities of the 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 kept for 6 months at a temperature not exceeding 25°C.

No special requirements.