ECONAZOLE VIATRIS 1 % Cutaneous emulsion Bottle/30g

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

For 100 g of emulsion for cutaneous application.

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

Allergens contained in the perfume: alpha-isomethyl ionone, benzyl alcohol, benzyl benzoate, cinnamal, citral, coumarin, limonene, eugenol, geraniol, hydroxycitronellal, linalool, 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.

• Mycoses of the mucous membranes and semi-mucous membranes: vulvitis, balanitis, anitis, perianal candidiasis.

• Mycoses of fragile skin: children, face.

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 of mycoses of the hair follicles: folliculitis, kerions, sycosis.

Dosage

Apply ECONAZOLE VIATRIS 1 %, emulsion to the skin 2 to 3 times a day, without exceeding 3 applications per day. Treatment should be continued for 2 to 4 weeks.

Paediatric population

Not applicable.

Method of administration

Cutaneous use.

Apply the emulsion to the lesions to be treated with the fingertips, a few drops having been placed in the palm 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: it is not recommended 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, mouth or nose.

• 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 VIATRIS 1 %, emulsion for cutaneous application and after its discontinuation (see section Interactions).

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

Excipients

This medicine contains 200 mg of benzoic acid per 100 g of emulsion. Benzoic acid may cause local irritation and may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

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

This medicine contains butylhydroxytoluene (E321). Butylhydroxytoluene (E321) may cause local skin reactions (for example contact dermatitis) or irritation of the eyes and mucous membranes.

This medicine contains a fragrance containing the following substances: alpha-isomethyl ionone, benzyl alcohol, benzyl benzoate, cinnamal, citral, coumarin, limonene, eugenol, geraniol, hydroxycitronellal, linalool, citronellol. These substances may cause allergic reactions.

Associations requiring precautions for use

Econazole is an 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 VIATRIS 1 %, emulsion for cutaneous application in pregnant women, nor relevant epidemiological data.

 Consequently, ECONAZOLE VIATRIS 1 %, emulsion for cutaneous application should not be used during the first trimester of pregnancy, unless the physician considers it essential for the mother.

ECONAZOLE VIATRIS 1 %, emulsion for cutaneous application 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 VIATRIS 1 %, emulsion for cutaneous application can result in sufficient systemic absorption of econazole to produce detectable amounts in breast milk. Caution should be exercised when ECONAZOLE VIATRIS 1 %, emulsion for cutaneous application is used by breastfeeding mothers. Do not apply to the breasts during breastfeeding.

The safety of econazole nitrate, in all forms combined, was evaluated in 470 patients who participated in 12 clinical trials treated either with the emulsion for cutaneous application form (8 clinical trials) or with the emulsion form (4 clinical trials). The most frequently reported adverse effects were: pruritus (1,3 %), burning sensation (1,3 %), pain (1,1 %).

Adverse effects reported during clinical trials and since marketing of econazole nitrate in 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), 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 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 VIATRIS 1 %, cutaneous emulsion must only be used cutaneously. 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: 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 is exerted 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.

In vivo experiments 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 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 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.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years

Do not store above +25°C.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.