KETOCONAZOLE SANDOZ 2 % Gel in single-dose sachet 8Sach/6g

Ketoconazole.............................................................................................................................................. 120 mg

For one sachet-dose of 6 g.

Excipient with known effect: sodium lauryl sulfate (E 487).

One single-dose sachet of 6 g contains 540 mg of sodium lauryl sulfate (E 487).

This medicine is indicated for the treatment of seborrheic dermatitis in adults and adolescents (≥ 12 years).

The use of KETOCONAZOLE SANDOZ 2 %, single-dose sachet gel is reserved for adults and adolescents (≥ 12 years).

The safety and efficacy of KETOCONAZOLE SANDOZ 2 %, single-dose sachet gel have not been established in children under 12 years of age. No data are available.

Dosage

1 sachet is sufficient for one application.

During the first month of treatment, the dosage is usually 2 applications per week.

A maintenance treatment may be deemed necessary by the physician; it is usually one application per week or every two weeks depending on the results obtained.

Method of administration

Cutaneous application to the scalp and/or skin.

• Thoroughly wet the affected areas, skin and/or scalp.
• Apply the gel, lather thoroughly, paying particular attention to the affected areas.
• Avoid contact with the eyes.
• Leave in place for 5 minutes. For good efficacy, it is important to respect this minimum duration.
• Then rinse the skin and/or scalp thoroughly, and not only the hair.

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

Special warnings

When using KETOCONAZOLE SANDOZ 2 %, single-dose sachet gel in patients who have received prolonged treatment with topical corticosteroids, it is recommended to gradually discontinue corticosteroid therapy over a period of 2 to 3 weeks in order to avoid any potential rebound effect.

Precautions for use

Avoid contact with the eyes. In case of accidental contact with the eye, rinse with water.

Excipients

This medicine contains 540 mg of sodium lauryl sulfate per single-dose sachet.

Sodium lauryl sulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.

Given the low systemic exposure to ketoconazole after application of KETOCONAZOLE SANDOZ 2 %, gel in single-dose sachet, drug interactions are unlikely to be clinically significant.

Pregnancy

No effect of KETOCONAZOLE SANDOZ 2 %, gel in single-dose sachet during pregnancy is expected since maternal systemic exposure is negligible. KETOCONAZOLE SANDOZ 2 %, gel in single-dose sachet may therefore be used during pregnancy.

Breast-feeding

No effect of KETOCONAZOLE SANDOZ 2 %, gel in single-dose sachet in breastfed newborns or infants is expected, since maternal systemic exposure is negligible.

KETOCONAZOLE SANDOZ 2 %, gel in single-dose sachet may therefore be used during breastfeeding.

The tolerability of ketoconazole administered to the scalp and/or skin was evaluated in 2890 patients across 22 clinical trials. Based on the pooled tolerability data from these clinical trials, no adverse reaction with an incidence ≥ 1% was reported.

The adverse effects 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 frequency 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 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.

Ingestion

In case of accidental ingestion, treatment will be limited to supportive and symptomatic measures.

In order to avoid aspiration of gastric contents, do not perform gastric lavage or induced vomiting.

Pharmacotherapeutic class: Antifungal for topical use - 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 local administration of ketoconazole to the scalp.

Low but occasionally measurable plasma concentrations (from 11 to 33 ng/mL with an assay detection limit of 5 ng/mL) were observed in 3 out of 6 patients with a Pityriasis versicolor after local administration of ketoconazole over the entire body (estimated dose of 400 mg for 5 minutes).

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 starting from doses of 80 mg/kg; however by cutaneous 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.

18 months.

Store at a temperature not exceeding 25°C.

No special requirements.