GANAZOLO EMULS CUT 30ML 1%

GANAZOLO 10 MG/G

active ingredients

GANAZOLO 10 mg/g cream 1g cream contains: Active ingredient: Econazole nitrate 10 mg. Excipients with known effects: propylene glycol 100 mg, methyl p-hydroxybenzoate 1.5 mg, propile p-hydroxybenzoate 0.8 mg. For the full list of excipients see paragraph 6.1 GANAZOLO 10 mg/g skin emulsion 1 g emulsion contains: Active ingredient: Econazole nitrate 10 mg. Excipients with known effects: propylene glycol 100 mg, methyl p-hydroxybenzoate 1.5 mg, propile p-hydroxybenzoate 0.8 mg. For the full list of excipients see paragraph 6.1.

Excellent

Cream Polyglycolic aesthetics of saturated fatty acids - Propilene glycol - P-hydroxybenzoate methyl - Propile pidroxybenzoato - Acqua deionizzato. Skin emulsion Polyglycolic aesthetics of saturated fatty acids - glycol-propylene- P-hydroxybenzoate - Propile pidrossibenzoato - Distilled water.

Therapeutic indications

1.Micosi skin caused by: dermatophytes, yeasts and mold. 2.Infezioni cutaneous supported by gram-positive bacteria: Streptococci - Staphylococci. 3.Mycotic external otis, mycosis of the auditory duct (limited to emulsion form). 4.Onicomicosi. 5. Pityriasis Versicolor.

Contraindications

Hypersensitivity to the active ingredient or other substances related to the chemical or any of the excipients listed in the paragraph 6.1.

Population

GANAZOLO must be applied morning and evening in infected skin areas, with a slight massage, up to total disappearance of mycosis (1 - 3 weeks). It is recommended to continue the application of GANAZOLO for a few days after the disappearance of the mycosis. Intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) at the humid stage should be laid with gauze or bandages before the application of GANAZOLO.In the treatment of otomycosis (only if there is no lesion of thympane) instill 1-2 times a day 1-2 drops of GANAZOLO emulsion, or insert a strip of gauze funnel with emulsion in the outer ear canal. An occlusive bandage is recommended in the treatment of onicomycosis.

Conservation

These medicines do not require special conditions of conservation.

Warnings

Only for external use. GANAZOLO should not be used for ophthalmic or oral use. If an awareness or irritation reaction occurs, the use of the product must be stopped. Important information about some excipients GANAZOLO contains p-hydroxybenzoate methyl and p-hydroxybenzoate propile that can cause allergic reactions (also delayed). GANAZOLO 10 mg/g cream contains 150 mg of glycol propylene in 1.5 g cream equivalent to 100 mg/g. GANAZOLO 10 mg/g skin emulsion contains 8.5 mg of glycol propylene in 2 drops of emulsion equivalent to 100 mg/g. Glycol propylene can cause skin irritation.

Interactions

Econazole is a well-known cytochrome inhibitor CYP3A4/2C9. Despite poor systemic availability after skin application, significant interactions may occur in the clinical profile. In fact, clinically relevant reactions were reported in patients taking anticoagulants, such as warfarin or acenocumarol. With such patients it is necessary to use caution and monitor the INR with greater frequency. During treatment with econazole and after its interruption it may be necessary to correct the dosage of oral anticoagulant.

Effects

Local irritations occur in rare cases, for example in skin areas with eczematous characteristics. The use of topical products, especially if protracted, can give rise to awareness phenomena. In case of hypersensitivity reactions it is necessary to interrupt the treatment and to establish suitable therapy, as is said in case of development of nonsensical microorganisms. Data resulting from clinical studies The safety of nitrate econazole cream (1%) and emulsion nitrate econazole (1%) has been evaluated in 470 individuals participating in 12 clinical studies, which received at least one administration of each formulation. From all the data collected in such studies, the most common (impact ≥1%) adverse reactions to the drug reported were (with % incidence): itching (1.3%), skin burning sensations (1.3%) and pain (1.1%). The following table shows the undesirable reactions to the drug reported by clinical studies or post-marketing experience on the use of dermatological formulations of Ganazole, including the unwanted reactions above-listed. The frequency classes listed are in accordance with the following convention: very common (≥1/10); common (≥1/100; Table 1 Reactions unwanted to the drug

Classification for systems and organs	Undesirable reactions to the drug
	Frequency class
	Town (≥1/100;	Not common(≥1/1,000;	Notable
Pathologies of skin and subcutaneous tissue	Prurito Sensation of skin burning	Eritema	Angioedema Contact Dermatitis Rash Orticaria Vescicole Exfoliation of the skin
Systemic pathologies and conditions for administration	Pain	Malessere Gonfiore

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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

Pregnancy

In animal studies, nitrate econazole has not shown teratogenic effects, but has been shown to be fetotoxic in rodents at subcutaneous maternal doses of 20mg/kg/day and at oral maternal doses of 10 mg/kg/day. The relevance of this effect on human beings is not known. In man, the systemic absorption of econazole, after topical application on intact skin, is low (GANAZOLO in pregnancy, nor related epidemiological data. The limited number of postmarketing data has not been identified with undesirable effects of GANAZOLO on pregnancy or health of the fetus and the newborn. Due to systemic absorption, GANAZOLO should not be used in the first trimester of pregnancy unless the doctor considers it necessary for the health of the patient. GANAZOLO can be used during the second and third quarter if potential benefits exceed the possible risks to the fetus.

Food

After oral administration of nitrate econazole in nursing rats, econazole and/or its metabolites were excreted in milk and were found in small ones. It is not known if the skin administration of GANAZOLO can cause a systemic absorption of econazole to produce detectable quantities in breast milk. Use caution in case of administration GANAZOLO to nursing women.

Source: Farmadati