KETOCONAZOLE BIOGARAN 2 % Cream T/15g

Ketoconazole..........................................................................................................................................................2 g

For 100 g of cream.

Excipients with known effect: 1 g of cream contains 200 mg of propylene glycol, 75 mg of stearyl alcohol and 20 mg of cetyl alcohol.

This medicine is indicated for the topical treatment of dermatophyte skin infections, cutaneous candidiasis and Pityriasis versicolor, in adults.

The use of KETOCONAZOLE BIOGARAN is reserved for adults.

Cutaneous candidiasis, dermatophytoses of the body skin, inguinal dermatophytoses, dermatophytoses of the hand, athlete's foot and pityriasis versicolor : it is recommended that KETOCONAZOLE BIOGARAN be applied once or twice daily to cover the affected area and its immediate surroundings.

The usual duration of treatment is: from 2 to 3 weeks for pityriasis versicolor, from 2 to 3 weeks for cutaneous yeast infection, from 2 to 4 weeks for inguinal dermatophytoses, from 3 to 4 weeks for dermatophytoses of the body skin, from 4 to 6 weeks for athlete's foot.

Paediatric population

The safety and efficacy of KETOCONAZOLE BIOGARAN have not been established in children under the age of 18 years.

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

The cream is not suitable for ophthalmic use.

In patients receiving a dermocorticoid as prolonged treatment, application of a low-potency dermocorticoid should be continued in the morning and KETOCONAZOLE BIOGARAN applied in the evening, then corticotherapy should be gradually stopped over a period of 2 to 3 weeks in order to avoid a potential rebound effect.

• Candidiasis: it is not recommended to use an acidic pH soap (pH favouring the multiplication of candida).

• The low rate of cutaneous absorption makes the occurrence of systemic effects unlikely. However, over a large surface area and/or on damaged skin, caution is required.

This medicine contains:

• propylene glycol and may cause skin irritation,

• cetyl alcohol and stearyl alcohol and may cause local skin reactions (for example contact dermatitis).

Given the low systemic exposure to ketoconazole after application of KETOCONAZOLE BIOGARAN, drug interactions are unlikely to be clinically significant.

Pregnancy

No effect of KETOCONAZOLE BIOGARAN during pregnancy is expected since maternal systemic exposure is negligible. KETOCONAZOLE BIOGARAN may therefore be used during pregnancy.

Breast-feeding

No effect of KETOCONAZOLE BIOGARAN on the breastfed newborn or infant is expected, since maternal systemic exposure is negligible. KETOCONAZOLE BIOGARAN may therefore be used during breastfeeding.

The tolerability of topically applied ketoconazole was evaluated in 1079 subjects during 30 clinical trials.

Based on the pooled tolerability data from these clinical studies, the most frequently reported adverse reactions (incidence ≥ 1%) were: pruritus at the application site (2%), burning sensation of the skin (1,9%) and erythema at the application site (1%).

Adverse reactions reported with ketoconazole, either during clinical studies or after marketing, are listed below by frequency category, according to the following 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) and not known (cannot be estimated from the available data).

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/.

Ingestion

In case of accidental ingestion, treatment will be limited to supportive and symptomatic measures. To avoid aspiration of gastric contents, do not perform gastric lavage or induce vomiting.

Pharmacotherapeutic class: topical antifungals, imidazole and triazole derivatives, ATC code: D01AC08.

Ketoconazole is an antifungal of the imidazole group.

It has potent antifungal activity against:

• dermatophytes: in particular Trichophyton sp., Epidermophyton sp., Microsporum sp.,

• yeasts: in particular Candida sp. and Malassezia furfur (Pityrosporum ovale).

In vitro and in vivo in animals, ketoconazole inhibits the synthesis of leukotrienes.

Plasma concentrations of ketoconazole are not detectable after administration of ketoconazole to the skin in adults.

In a study in children with seborrhoeic dermatitis (n=19), plasma concentrations of ketoconazole were detected in 5 children, ranging from 32 to 133 ng/mL after daily application of 40 g of ketoconazole over 40% of the body surface.

Non-clinical data from conventional studies, including primary ocular or skin irritation, skin sensitisation and repeated-dose dermal toxicity, did not reveal any particular risk for humans.

Ketoconazole is teratogenic in rats by oral route from doses of 80 mg/kg; however, by dermal route the plasma concentrations of ketoconazole are 6000 times lower than those found by oral route for a dose of 40 mg/kg in rats.

3 years.

Shelf life after first opening: 1 month.

This medicine does not require any particular storage precautions.

No special requirements.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree