ECONAZOLE TEVA SANTE 1 % Cream Tube/30g

Econazole nitrate.................................................................................................................................................. 1,0000 g

For 100 g.

Excipients with known effect: benzoic acid (E210), butylhydroxyanisole (E320), citronellol, butylhydroxytoluene (E321).

Each gram of cream contains 2 mg of benzoic acid (E210).

Candidiasis

Cutaneous candidiasis encountered in human clinical practice is usually due to Candida albicans. However, the demonstration of a Candida on the skin cannot in itself constitute an indication;

• Treatment of fold mycoses that are not macerated:
  • Genital intertrigo,
  • Submammary,
  • Interdigital.
• Treatment of nail mycoses: onychomycosis, perionychomycosis. An associated systemic antifungal treatment is necessary.

Antifungal treatment of a possible digestive and/or vaginal focus is required in candidiasis of the inguinal and intergluteal folds to prevent recurrences.

Dermatophytoses

• Treatment:
  • Dermatophytoses of glabrous skin,
  • Non-macerated genital and crural intertrigo.
• Treatment of tinea capitis.

An associated systemic antifungal treatment is necessary.

Erythrasma

Dosage

Apply ECONAZOLE TEVA SANTE to the skin 2 to 3 times a day, without exceeding 3 applications per day. Treatment must be continued for 2 to 4 weeks.

Method of administration

Cutaneous use.

Apply the cream to the lesions to be treated with the tips of the fingers, a few drops having been placed in the hollow of the hand or directly on the lesions. Massage gently and regularly until complete penetration.

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

For external use only.

• The simultaneous use of latex condoms or diaphragms with vaginal anti-infective preparations may reduce the effectiveness of rubber contraceptive agents. Therefore, products such as econazole cream must not be used simultaneously with a diaphragm or latex condom. Patients who use spermicidal contraceptives should consult their doctor because any local vaginal treatment may inactivate the spermicidal contraceptive (see section "Interactions with other medicines and other forms of interaction").
• Candidiasis: it is not advised to use an acidic pH soap (a pH that promotes the multiplication of Candida).
• The risk of systemic passage must be taken into account in situations where the phenomenon of local occlusion may recur (for example elderly subjects, pressure sores, submammary intertrigo).
• Do not apply in the eye, nose or generally on mucous membranes.
• Drug interaction with vitamin K antagonists: INR must be monitored more frequently and the dose of the vitamin K antagonist adjusted during treatment with ECONAZOLE TEVA SANTE and after its discontinuation (see section Interactions).

Excipients

Benzoic acid (E210)

Benzoic acid may cause immediate non-immunological contact reactions through a possible cholinergic mechanism.

Perfume containing citronellol

Citronellol may cause allergic reactions. In addition to allergic reactions in sensitised patients, non-sensitised patients may become sensitised.

Butylated hydroxyanisole (E320) and butylated hydroxytoluene (E321)

This medicine may cause local skin reactions (for example: contact dermatitis) or irritation of the eyes and mucous membranes.

If a hypersensitivity (allergic) or irritation reaction occurs, treatment must be discontinued.

Contact should be avoided between latex products such as contraceptive diaphragms or condoms and econazole cream, since the constituents of econazole cream may damage latex. Patients who use spermicidal contraceptives should consult their doctor because any local vaginal treatment may inactivate the spermicidal contraceptive (see section "Special warnings and precautions for use").

Associations subject to precautions foruse

Econazole is a known inhibitor of CYP3A4/2C9.

+ Vitamin K antagonists (acenocoumarol, fluindione, warfarin)

Increased effect of the vitamin K antagonist and risk of bleeding.

More frequent monitoring of INR. Possible adjustment of the vitamin K antagonist dose during treatment with econazole and after its discontinuation.

Pregnancy

Preclinical studies have shown reproductive toxicity (see section Preclinical safety).

Systemic absorption of econazole is low (< 10 %) after application to healthy skin in humans. There are no adequate and well-controlled studies on the harmful effects of using ECONAZOLE TEVA SANTE in pregnant women, nor relevant epidemiological data.

Accordingly, ECONAZOLE TEVA SANTE must not be used during the first trimester of pregnancy, unless the doctor considers it essential for the mother.

ECONAZOLE TEVA SANTE may be used during the second and third trimesters if the potential benefit to the mother outweighs the possible risks to the foetus.

Breast-feeding

After oral administration of econazole nitrate to lactating rats, econazole and/or its metabolites were excreted into the milk and were found in the pups.

It is not known whether cutaneous application of ECONAZOLE TEVA SANTE can result in sufficient systemic absorption of econazole to produce detectable amounts in human milk. Caution should be exercised when ECONAZOLE TEVA SANTE is administered to a nursing woman. Do not apply to the breasts during breast-feeding.

The safety of ECONAZOLE TEVA SANTE, all forms combined, was evaluated in 470 patients who participated in 12 clinical trials treated either with the cream form (8 clinical trials) or with the emulsion form (4 clinical trials). The most frequently reported adverse reactions were: pruritus (1,3%), burning sensation (1,3%), pain (1,1%).

Adverse reactions reported during clinical trials and since the marketing of ECONAZOLE TEVA SANTE, all forms combined, are classified by System Organ Class and by frequency using the following categories: 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), 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/

No cases of overdose have been reported to date.

Treatment:

ECONAZOLE TEVA SANTE must be used for cutaneous use only. In case of accidental ingestion, treatment will be symptomatic.

If this medicine is accidentally applied to the eyes, rinse with clear water or a saline solution and consult a doctor if symptoms persist.

Pharmacotherapeutic classification: ANTIFUNGAL FOR TOPICAL USE - IMIDAZOLE AND TRIAZOLE DERIVATIVES, ATC code: D01AC03.

Mechanism of action

Econazole nitrate is an imidazole derivative with antifungal and antibacterial activity.

The antifungal activity has been demonstrated in vitro and acts on the agents responsible for cutaneous and mucosal mycoses:

• Dermatophytes (Trichophyton, Epidermophyton, Microsporum),
• Candida and other yeasts,
• Malassezzia furfur (agent of Pityriasis Capitis and of Pityriasis Versicolor),
• Moulds and other fungi.

The antibacterial activity has been demonstrated in vitro against Gram-positive bacteria.

Its mechanism of action, which differs from that of antibiotics, operates at several levels: membrane (increased permeability), cytoplasmic (inhibition of oxidative processes at the level of the mitochondria), nuclear (inhibition of RNA synthesis).

• Activity on Corynebacterium minutissimum (erythrasma),
• Actinomycetes.

The experiments in vivo performed in healthy volunteers (with or without occlusive dressing) showed that econazole nitrate penetrated the deepest dermal cell layers. In the upper layers of the dermis and in the epidermis, econazole nitrate reaches fungicidal concentrations. Econazole nitrate accumulates in large amounts in the stratum corneum and remains there for 5 to 16 hours. The stratum corneum thus acts as a reservoir.

The rate of systemic absorption is approximately between 0,5% and 2% of the applied dose.

Transcutaneous passage may be increased on damaged skin.

A low neonatal survival rate and fetal toxicity have only been reported in cases of maternal toxicity. In animal studies, econazole nitrate showed no teratogenic effect but was fetotoxic in rodents at maternal doses of 20 mg/kg/day subcutaneously and 10 mg/kg/day orally. The transferability of these observations to humans is unknown.

3 years.

Store at a temperature not exceeding 25°C.

No special requirements.