“Indications: Vulvovaginal mycoses. Fungal balanitis.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients or to other chemically related substances.
Notes:
Ganazolo vaginal cream is for external use (not for ophthalmic or oral use).
Concomitant use of latex condoms or diaphragms with anti-infective drugs may reduce the effectiveness of rubber contraceptives. Therefore, the use of such products in combination with diaphragms or latex condoms is not recommended. Patients using spermicidal contraceptives should consult their physician as topical vaginal treatments may reduce the effectiveness of the spermicide.
It is not recommended to use it in combination with other means for internal or external treatment of the genitals. If noticeable irritation or sensitization occurs, treatment should be discontinued.
Patients with sensitivity to imidazole have also been found to be sensitive to econazole nitrate.
Due to vaginal absorption, it should not be used in the first trimester of pregnancy, unless the doctor considers it necessary for the patient’s health.
Can be used in the second and third trimesters if the potential benefit outweighs the possible risk to the fetus. It is not known whether econazole nitrate is excreted in breast milk. Should be used with caution when prescribed to patients who are breastfeeding.
Studies of the effect on the ability to drive vehicles and operate machinery have not been conducted.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those sold without a prescription.
Econazole is a known inhibitor of cytochromes CYP3A4/2C9. Despite the low systemic availability following vaginal administration, a clinically significant interaction could and has been observed in patients receiving anticoagulants such as warfarin or acenocoumarol. In such patients, caution should be exercised and the INR should be monitored more frequently. During treatment with econazole and at the end of treatment, dose adjustment of the oral anticoagulant may be necessary.
Application:
For 15 days, every evening before going to bed, insert an applicator filled with vaginal cream (5 ml) deep into the vagina, preferably while lying down. Treatment must be continued even after the disappearance of subjective complaints.
Partner treatment: the cream is applied once a day for 15 days in a row after washing the glans and foreskin with warm water.
In case of relapse or if after a week of treatment the control culture test is positive, the second cycle of therapy is repeated.
It is recommended to consult your doctor or pharmacist for appropriate instructions on the use of the drug.
Cases of overdose of econazole nitrate have not yet been reported. If accidentally swallowed, nausea, vomiting and diarrhea may occur. If necessary, carry out symptomatic therapy.
If you accidentally swallow/take Ganazolo, tell your doctor or go to your nearest hospital immediately.
Possible side effects:
Like all medicines, Ganazolo can cause side effects, although not everyone gets them.
The most common side effects reported in clinical studies 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 this type of drug in the early stages of treatment. In these cases, it is necessary to suspend treatment and prescribe appropriate therapy.
Other possible adverse reactions to the drug arising from post-marketing experience include:
with unknown frequency they may include the following: angioedema, rash, urticaria and hypersensitivity.
If any unwanted effects occur, especially if they are different from those described, the patient is strongly advised to report them to their doctor or pharmacist.
Following the instructions contained in the package leaflet will reduce the risk of side effects.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Warning: Do not use the drug after the expiration date indicated on the package.
Keep the medicine out of the reach of children.
Compound:
100 g of vaginal cream contains:
Active ingredient: econazole nitrate 1.00 g.
Excipients: Polyglycol ester of saturated fatty acids – Propylene glycol – Methyl p-hydroxybenzoate – Propyl p-hydroxybenzoate – Deionized water.
Packaging: tube 30 g”
