FUSIDATE DE SODIUM PIERRE FABRE 2 % Ointment 1Tube/15g

Sodium fusidate...........................................................................................................................................2,0 g

For 100 g of ointment.

One tube of 15 g contains 0,300 g of sodium fusidate.

Excipients with known effect: wool fat (6 g), cetyl alcohol (0,5 g).

Skin infections, in adults and children, including infants, due to staphylococcus and streptococcus:

• Impetigo and impetiginized dermatoses:

• topical treatment only in localised forms with a small number of lesions.
• as adjunctive topical treatment in association 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 antibacterials should be taken into account.

Dosage

In adults and children, including infants:

Topical application with or without a dressing, once or twice daily after cleansing the infected surface.

Limit treatment to one week, as a guide.

Method of administration

Cutaneous use.

Avoid application in a thick layer, particularly in infants (see sections Adverse effects and Overdose).

Do not use 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

Absorption and systemic passage of the antibiotic cannot be ruled out in cases of extensive epidermal lesions and in cases of leg ulcers.

Cutaneous sensitisation may compromise subsequent systemic use of the same antibiotic (see section Adverse effects).

Bacterial resistance of Staphylococcus 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.

This medicine contains wool fat and cetyl alcohol and may cause local skin reactions (for example: contact dermatitis).

This pharmaceutical form is not suitable for application to the eye or to the inner surface of the eyelids.

No interaction study has been carried out. Interactions with systemically administered medicinal products are considered minimal, as the systemic absorption of FUSIDATE DE SODIUM PIERRE FABRE by the topical route 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 is expected in breastfed newborns/infants, since systemic exposure of the breastfeeding woman to fusidic acid is negligible.

FUSIDATE DE SODIUM PIERRE FABRE by the topical route may be used during breastfeeding, but it is recommended to avoid applying it to the breast.

Fertility

No clinical study on the effects of FUSIDATE DE SODIUM PIERRE FABRE by the topical route on fertility has been conducted.

Fusidate de sodium Pierre Fabre has no effect or only a 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 in clinical studies including 4 724 patients to whom fusidic acid cream or ointment was administered, 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 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 edema have been reported.

Undesirable effects are presented by system organ class (SOC, System Organ Class) 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), Not known (cannot be estimated from the available data)

* Eczema lesions may spread to areas distant from the treated sites.

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

Possibility of selecting strains resistant to the antibiotic used locally, which is detrimental to (subsequent) oral use of the same antibiotic. However, most often, strains resistant in vivo become sensitive again after a short latency period.

Depending on the percutaneous absorption of the product, care should be taken not to treat for too long or over too large areas, particularly in infants (due to immature hepatic function), as the possibility of hepatic adverse effects cannot be completely ruled out.

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/

The occurrence of an overdose is unlikely.

No cases of overdose have been reported to date.

Paediatric population

The appearance of hepatic disorders cannot be excluded in case of excessive application over a large area of skin, particularly in infants.

Pharmacotherapeutic class: Other antibiotics for topical use, 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:

This spectrum corresponds to that of the systemic forms of fusidic acid. With 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.

Absorption

Fusidic acid, given its surface-active properties and its both lipophilic and hydrophilic nature, penetrates well through the skin.

Distribution

Fusidic acid is found in all layers of the cutaneous and subcutaneous tissue.

2 years.

No special precautions for storage.

No special requirements.