ECONAZOLE BIOGARAN 1 % Cream Tube/30g

Econazole nitrate............................................................................................................................................ 1 g

Quantity corresponding to econazole base.............................................................................................. 0,86 g

For 100 g of cream.

Excipients with known effect : benzoic acid, butylated hydroxyanisole, dipropylene glycol.

Allergens contained in the fragrance: citronellol.

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 fungal infections of non-macerated skin folds: genital, submammary and interdigital intertrigo.
• Treatment of fungal nail infections: onychomycosis, perionyxis. Concomitant 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. Concomitant systemic antifungal treatment is necessary.

Erythrasma

Dosage

Apply ECONAZOLE BIOGARAN to the skin 2 to 3 times a day, without exceeding 3 applications per day. Treatment should 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.

• Candidiasis: use of a soap with an acidic pH (pH favouring 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, the nose or generally on mucous membranes;
• Drug interaction with vitamin K antagonists: the INR must be monitored more frequently and the dose of the vitamin K antagonist adjusted during treatment with ECONAZOLE BIOGARAN and after its discontinuation (see section Interactions).

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

This medicine contains 60 mg of benzoic acid per tube of 30 g of cream. Benzoic acid may cause local irritation. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

This medicine contains butylated hydroxyanisole (E320) and may cause local skin reactions (for example contact dermatitis) or irritation of the eyes and mucous membranes.

This medicine contains propylene glycol and may cause skin irritation.

This medicine contains a fragrance containing citronellol and may cause allergic reactions.

Associations subject to precautions for use

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).
The 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 in pregnant women, nor any relevant epidemiological data.
Consequently, ECONAZOLE BIOGARAN must not be used during the first trimester of pregnancy, unless the physician considers it essential for the mother.
ECONAZOLE BIOGARAN may be used during the second and third trimesters if the potential benefit for 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 BIOGARAN can result in sufficient systemic absorption of econazole to produce detectable quantities in breast milk. Caution should be exercised when ECONAZOLE BIOGARAN is used by mothers who are breastfeeding. Do not apply to the breasts during breastfeeding.

The safety of econazole, all forms combined, was evaluated in 470 patients who took part in 12 clinical trials treated either with the cream form (8 clinical trials) or 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, 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 (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after marketing authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: the National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres for Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr.

No cases of overdose have been reported to date.

Treatment

ECONAZOLE BIOGARAN must be used only by the cutaneous route. 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 class: ANTIFUNGALS 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 (increase in permeability), cytoplasmic (inhibition of oxidative processes at the level of the mitochondria), and nuclear (inhibition of RNA synthesis).

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

The experiments in vivo performed in healthy volunteers (with or without an 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 quantities 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 foetal toxicity have been reported only in cases of maternal toxicity. In animal studies, econazole nitrate showed no teratogenic effect but was foetotoxic in rodents at maternal doses of 20 mg/kg/day subcutaneously and 10 mg/kg/day per os. The transposability of these observations to humans is unknown.

3 years.

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