Ganazolo Emulsione Cutanea 1% Econazolo Antimicotico 30 ml

Skin emulsion based on econazole nitrate.

Therapeutic indications

Ganazol Cutaneous Emulsion is used in the treatment of:

• Cutaneous mycoses caused by: dermatophytes, yeasts and molds
• Skin infections caused by Gram positive bacteria: Streptococci - Staphylococci
• Fungal external otitis, mycosis of the ear canal (limited to the emulsion form)
• Onychomycosis
• Pityriasis Versicolor.

Dosage and Posology

The drug should be taken according to the following doses and methods: Ganazol should be applied morning and evening to the infected skin areas, with a light massage until the mycosis has completely disappeared (1 - 3 weeks). It is advisable to continue the application of Ganazol for a few days after the disappearance of the mycosis. Intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) in the wet stage should be cleansed with gauze or bandages before applying Ganazol. In the treatment of otomycosis (only if there is no lesion of the eardrum) instill 1-2 drops of Ganazol emulsion 1-2 times a day, or insert a strip of gauze soaked with the emulsion into the external auditory canal. An occlusive dressing is recommended in the treatment of onychomycosis

Overdose

Ganazol is intended for skin application only. In case of accidental ingestion, treat with symptomatic therapy. Given the pharmaceutical forms available for topical application, cases of acute overdose by ingestion are extremely unlikely and so far never reported. In case of accidental ingestion, nausea, vomiting and diarrhea may occur and should be treated with symptomatic therapy. If the product accidentally comes into contact with the eyes, wash with clean water or physiological solution and consult a doctor if symptoms persist

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Local irritation occurs in very rare cases, for example in areas of the skin with eczematous characteristics. The use of products for topical use, especially if prolonged, can give rise to sensitization phenomena. In case of hypersensitivity reactions it is necessary to interrupt the treatment and institute a suitable therapy, the same applies in case of development of non-sensitive microorganisms.

The safety of econazole nitrate skin emulsion (1%) and econazole nitrate emulsion (1%) was evaluated in 470 subjects participating in 12 clinical studies, who received at least one administration of each formulation. From the pool of data collected in these studies, the most common (incidence ≥1%) adverse drug reactions reported were (with% incidence): pruritus (1.3%), skin burning sensations (1.3%) and pain (1.1%). The following table shows the adverse drug reactions reported from clinical studies or post-marketing experience on the use of dermatological formulations of GGanazole, including the adverse reactions listed above. The frequency classes reported are in accordance with 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 available clinical trial data). In the following table, relating to the undesirable reactions of the dermatological formulations of GGanazole, all undesirable reactions with known incidence (common or uncommon) come from clinical data and all undesirable reactions with unknown incidence come from post-marketing experience.

- Skin and subcutaneous tissue disorders

• Common: Pruritus, Skin burning sensation
• Uncommon: Erythema
• Not known: Angioedema, Contact dermatitis, Rash, Urticaria, Blisters, Skin exfoliation

- General disorders and administration site conditions

• Common: Pain
• Uncommon: Malaise, Swelling

Pregnancy and breastfeeding

In animal studies, econazole nitrate did not show teratogenic effects, but was foetotoxic in rodents at maternal subcutaneous doses of 20mg / kg / day and maternal oral doses of 10mg / kg / day. The relevance of this effect to humans is unknown. In humans, the systemic absorption of econazole after topical application to intact skin is low (<10%). There are no adequate and controlled studies on undesirable effects from the use of Ganazol in pregnancy, nor related epidemiological data. From the limited amount of post-marketing data, no undesirable effects of Ganazol on pregnancy or on the health of the fetus and neonate have been identified. Due to systemic absorption, Ganazole should not be used in the first trimester of pregnancy unless the doctor considers it necessary for the patient's health. Ganazol can be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus.

After oral administration of econazole nitrate to lactating rats, econazole and / or its metabolites were excreted in milk and were found in pups. It is not known whether dermal administration of Ganazole can cause systemic absorption of econazole to produce detectable quantities in human breast milk. Use caution when administering Ganazole to breastfeeding women

Special warnings

For external use only. Ganazol should not be used for ophthalmic or oral use. Should any sensitization or irritation reaction occur, the use of the product should be discontinued.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 gr of Ganazol skin emulsion contain:

Active principle

Econazole nitrate g 1.00

Excipients

Polyglycolic ester of saturated fatty acids - Propylene glycol - Methyl phydroxybenzoate - Propyl p-hydroxybenzoate - Distilled water.