Ganazolo Crema Vaginale 1% Econazolo 78g + Applicatori

Econazole nitrate based cream.

Therapeutic indications

Ganazolo Vaginal Cream is used in the treatment of vulvovaginal mycoses and fungal balanitis.

Dosage and Posology

The drug should be taken according to the following doses and methods: introduce an applicator filled with vaginal cream (5 cc) deep into the vagina for 15 days every night before going to bed, preferably in the supine position. The treatment must be continued even after the disappearance of the subjective disorders (itching, leucorrhoea).

Overdose

No cases of overdose with econazole nitrate have been reported so far. In case of accidental ingestion, nausea, vomiting and diarrhea may occur. If necessary, treat with symptomatic therapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Side effects

The most frequent side effects reported in clinical trials were application site reactions such as burning and stinging, itching and erythema. Vaginal burning and irritation, pelvic cramps, skin rashes and headaches have been reported with medicaments of this type in the early stages of treatment. In these cases it is necessary to suspend the treatment and institute a suitable therapy. Other possible undesirable reactions to the drug, deriving from post-marketing experience, with an unknown frequency, may be the following: angioedema, rash, urticaria and hypersensitivity.

Pregnancy and breastfeeding

In animal studies, econazole nitrate did not show teratogenic effects, but was foetotoxic at high doses. The relevance of this effect to humans is unknown. Due to vaginal absorption, Ganazol 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 econazole nitrate is excreted in human milk. Use Ganazol with caution when given to lactating patients.

Special warnings

Concomitant use of latex condoms or diaphragms with anti-infective preparations may reduce the effectiveness of rubber contraceptives. Therefore, products such as Ganazol should not be used in conjunction with latex diaphragms or condoms. Patients using spermicidal contraceptives should consult their doctor, as local vaginal treatments can inhibit the efficacy of the spermicide. Ganazol should not be used concomitantly with other products for internal or external treatment of the genitals. If marked irritation or sensitization occurs, discontinue treatment. Sensitivity to econazole nitrate was also found in patients with sensitivity to imidazole. Do not use for ophthalmic or oral use.

Expiration 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 Vaginal Cream contain:

Active principle

Econazole nitrate g 1.00

Excipients

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