TROSYD GINECOL 50 MG OVA 15 OVA

Name
TROSYD GYNECOLOGICAL 1% vaginal cream
TROSYD GYNECOLOGICAL 50 mg ovules
Equivalent medicine


What is it and what is it for?
Vulvovaginal mycoses (Trichophyton mentagrophytes, Epidermophyton, Malassetia furfur, Candida albicans, Nocardia minutissima).


What you need to know before taking the medicine
Hypersensitivity to the active substance or to any of the excipients.


Warnings and precautions
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
In animal studies, econazole nitrate has not shown teratogenic effects but has been shown to be fetotoxic at high doses. The relevance of this effect to humans is unknown.
Due to vaginal absorption, TROSYD GINECOLOGICO should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the health of the patient.
TROSYD GINECOLOGICO can be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus.

Breastfeeding
Following oral administration of econazole nitrate to lactating rats, econazole and/or its metabolites were excreted in milk and were detected in nursing pups.
It is not known whether econazole nitrate is excreted in human breast milk.
Caution should be exercised when TROSYD GINECOLOGICO is administered to women who are breastfeeding.

Effects on ability to drive and use machines
No one known.

Concomitant use of latex-containing condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptives. Therefore, products such as TROSYD GINECOLOGICO cream should not be used concomitantly with diaphragms or latex-containing condoms. Patients using spermicidal contraceptives should consult their doctor as local vaginal treatments may inactivate the effectiveness of spermicidal contraceptives (see section "Interactions").
TROSYD GYNECOLOGICO should not be used in combination with other products for the internal or external treatment of the genitals. If marked irritation or sensitivity occurs, treatment should be discontinued.
Patients with sensitivity to imidazoles have also reported sensitivity to econazole nitrate.
TROSYD GYNECOLOGICO is not for ophthalmic or oral use.


Possible side effects
Like all medicines, TROSYD GINECOLOGICO can cause side effects, although not everybody gets them.
The most frequently reported adverse reactions in clinical studies were application-site reactions, such as burning and stinging sensations, itching, and erythema. Use of the product, especially if prolonged, may result in sensitization. If hypersensitivity reactions occur, treatment should be discontinued and appropriate therapy instituted; similar steps should be taken if non-susceptible microorganisms develop.
The following table lists the ADRs that have been reported with the use of the gynaecological formulation in clinical trials or in post-marketing experience, including the adverse reactions mentioned above (ADRs - Adverse Drug Reactions).
Frequency categories are reported according to 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 (frequency cannot be estimated from the available data from clinical trials).
All ADRs with known incidence (common or uncommon) are from clinical trial data and all ADRs with unknown incidence are from postmarketing data.

Classification by systems and organs	Adverse Drug Reactions
	Frequency class
			Not known
Skin and body diseases of the subcutaneous tissue			Angioedema Rash Urticaria Erythema Itching Burning sensation Hypersensitivity

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.