TROSYD GINECOL*15 VAG OVUL 50MG

TROSYD GINECOLOGICO 1% vaginal cream
TROSYD GINECOLOGICO 50 mg pessaries
Equivalent medicine

What it is and what it is used 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 showed no teratogenic effects but was fetotoxic at high doses. The relevance of this effect in humans is not known.
Due to vaginal absorption, TROSYD GINECOLOGICO should not be used in the first trimester of pregnancy unless the doctor considers it necessary for the patient's health.
TROSYD GINECOLOGICO may be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus.

Breastfeeding
After oral administration of econazole nitrate to lactating rats, econazole and/or its metabolites were excreted in milk and detected in suckling 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 during breastfeeding.

Effects on ability to drive and use machines
None known.

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

Possible side effects
Like all medicines, TROSYD GINECOLOGICO can cause side effects, although not everyone gets them.
The most frequently reported adverse reactions in clinical studies were application site reactions, such as burning sensation and stinging pain, itching, and erythema. The use of the product, especially if prolonged, may lead to sensitization phenomena. In case of hypersensitivity reactions, treatment must be discontinued and appropriate therapy initiated; a similar course of action should be taken in case of development of non-sensitive microorganisms.
The following table shows the ADRs that have been reported with the use of the gynecological formulation in clinical studies or post-marketing experience, including the above-mentioned adverse reactions (ADRs - Adverse Drug Reactions).
Frequency classes 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 available data from clinical studies).
All ADRs with known incidence (common or uncommon) come from clinical trial data, and all ADRs with unknown incidence come from post-marketing data.

System Organ Class	Adverse Drug Reactions
	Frequency Class
			Not known
Skin and subcutaneous tissue disorders			Angioedema Rash Urticaria Erythema Pruritus Burning sensation Hypersensitivity

Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including those 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.