TROSYD 1% Крем

TROSYD GINECOLOGICO 1% cream
TROSYD GINECOLOGICO 1% cutaneous solution
Generic medicine

PHARMACOTHERAPEUTIC CATEGORY
Topical antimycotics.

THERAPEUTIC INDICATIONS
Skin mycoses caused by dermatophytes, yeasts and molds, also accompanied by infections
caused by Gram-positive bacteria.

CONTRAINDICATIONS
TROSYD GINECOLOGICO is contraindicated in patients who have shown hypersensitivity to the
active ingredient or to any of the excipients.

PRECAUTIONS FOR USE
For external use only. TROSYD GINECOLOGICO is not for ophthalmic or oral use.
If a sensitization reaction or irritation occurs, the use of the product must be
discontinued.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
Econazole is a known inhibitor of cytochrome CYP3A4 and CYP2C9. Despite the poor
systemic availability after topical application, clinically relevant interactions may occur that have been reported in patients receiving oral anticoagulants,
such as warfarin and acenocoumarol. In these patients, caution should be exercised and the INR should
be monitored more frequently. An adjustment of the dose of the oral anticoagulant drug
may be necessary during treatment with econazole and after its
discontinuation.

SPECIAL WARNINGS

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

Use during pregnancy
In animal studies, econazole nitrate has not shown teratogenic effects but has been
shown to be fetotoxic in rodents at maternal subcutaneous doses of 20mg/Kg/day and at maternal oral doses of 10mg/Kg/day. The relevance of this effect to humans is unknown.
In humans, the systemic absorption of econazole is low (<10%) after topical application on
intact skin. There are no adequate and controlled studies on the undesirable effects resulting
from the use of TROSYD GINECOLOGICO during pregnancy, and no other relevant epidemiological data are available. From the limited post-marketing data, no
adverse effects of TROSYD GINECOLOGICO on pregnancy or on the health
of the fetus and newborn have been identified.
Due to systemic absorption, TROSYD GINECOLOGICO should not be used in 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 trimester of
pregnancy if the potential benefits to the mother outweigh the possible risks to the fetus.

Use during breastfeeding
After oral administration of econazole nitrate to rats during lactation,
econazole and/or its metabolites have been excreted in milk and have been detected in suckling pups.
It is not known whether topical administration of TROSYD GINECOLOGICO may cause
systemic absorption of econazole sufficient to produce detectable amounts in human breast milk.
Caution should be exercised when TROSYD GINECOLOGICO is administered to women
during breastfeeding.

Effects on ability to drive and operate machinery
None known.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Apply morning and evening to the affected skin areas with gentle massage.
In the case of moist intertriginous spaces (spaces between the toes, gluteal folds) it is advisable to cleanse with gauze or bandages before applying TROSYD
GINECOLOGICO.
In the treatment of onychomycosis, an occlusive bandage is recommended.

OVERDOSE
TROSYD GINECOLOGICO is intended exclusively for topical application. In case of
accidental ingestion, nausea, vomiting and diarrhea may occur, treat with symptomatic therapy.
Given the pharmaceutical forms available, intended for topical application, cases of
acute overdose due to ingestion are extremely unlikely and have never been reported.
If the product accidentally comes into contact with the eyes, wash with clean water or
physiological solution and consult a doctor if symptoms persist.
In case of accidental ingestion/intake of an excessive dose of TROSYD
GINECOLOGICO, immediately inform the doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF TROSYD GINECOLOGICO, ASK YOUR
DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, TROSYD GINECOLOGICO can cause side effects, although
not everyone will experience them.

Data from clinical studies
The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) has been
evaluated on 470 subjects participating in 12 clinical studies, who received at least one of the
formulations. Based on the safety data collected
from these clinical studies, the most commonly reported adverse drug reactions (ADRs) (incidence ≥ 1%), are (with incidence in %): pruritus (1.3%),
burning skin sensation (1.3%), and pain (1.1%).
The following table reports the ADRs that have been reported with the use of dermatological formulations of econazole in clinical studies or in post-marketing experience. The frequency classes are reported in accordance with the following convention: very common (≥ 1/10);
common (≥ 1/100 to <1>1/1,000); very rare (<1>data available from clinical studies).
In the following table, all ADRs with known incidence (common or uncommon) come
from data from clinical studies and all ADRs with unknown incidence come from post-
marketing data.

Table 1: Adverse Drug Reactions (ADRs)

The use of the product, especially if prolonged, may lead to sensitization phenomena. In
case of hypersensitivity reactions, it is necessary to interrupt the treatment and institute
appropriate therapy; the same behavior must be adopted in case of development of
microorganisms not sensitive.
undesirable.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be
reported directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting of adverse reactions helps to provide more information on the
safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The date refers to the product in intact packaging, stored correctly.
WARNING: do not use the medicine after the expiry date printed on the
packaging.
No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

COMPOSITION
TROSYD GINECOLOGICO 1% cream:
100 g of cream contains:

Active ingredient: Econazole nitrate g 1.00

Excipients:polyglycol esters of fatty acids, propylene glycol, methyl parahydroxybenzoate,
propyl parahydroxybenzoate, deionized water.
TROSYD GINECOLOGICO 1% cutaneous solution:
100 ml of solution contains:

Active ingredient:Econazole nitrate g 1.00

Excipients:ethyl alcohol, propylene glycol, methyl parahydroxybenzoate, propyl
parahydroxybenzoate.

PHARMACEUTICAL FORM AND CONTENT
1% Cream – Tube of 30 g
1% Cutaneous solution – 1 Bottle of 30 ml

MARKETING AUTHORISATION HOLDER
Giuliani S.p.a. - Via Palagi, 2 - 20129 Milan

MANUFACTURER AND FINAL CONTROLLER
TROSYD GINECOLOGICO 1% cream:
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 – 03012 ANAGNI (FR)
TROSYD GINECOLOGICO 1% cutaneous solution:
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 POMEZIA (Rome)

MEDICINE:
TROSYD GINECOLOGICO 1% vaginal cream
TROSYD GINECOLOGICO 50 mg pessaries
Generic medicine

PHARMACOTHERAPEUTIC CATEGORY
Gynaecological anti-infectives and antiseptics.

THERAPEUTIC INDICATIONS
Vulvovaginal mycoses (Trichophyton mentagrophytes, Epidermophyton, Malassezia furfur,
Candida albicans, Nocardia minutissima).

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.

PRECAUTIONS FOR USE
Concomitant use of latex or diaphragm-containing contraceptives with vaginal anti-
infective preparations may decrease the effectiveness of latex contraceptives. Therefore, products such as
TROSYD GINECOLOGICO cream should not be used in conjunction with
diaphragms or latex contraceptives. 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 sensitivity to imidazoles have also reported sensitivity to econazole nitrate.
TROSYD GINECOLOGICO is not for ophthalmic or oral use.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
Econazole is a known inhibitor of cytochrome CYP3A4 and CYP2C9. Despite the poor
systemic availability after vaginal application, clinically relevant interactions may occur that have been reported in patients receiving oral anticoagulants,
such as warfarin and acenocoumarol. In these patients, caution should be exercised and the INR should
be monitored more frequently. An adjustment of the dose of the oral anticoagulant drug
may be necessary during treatment with econazole and after its
discontinuation.
Contact between products containing latex, such as diaphragms and
contraceptives, and TROSYD GINECOLOGICO cream should be avoided as the constituents of TROSYD
GINECOLOGICO may damage the latex. Patients using spermicidal
contraceptives should consult their doctor as any local vaginal treatment may
inactivate the spermicidal contraceptive (see section “Precautions for use”).

SPECIAL WARNINGS

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 in 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 trimester if the
potential benefits outweigh the possible risks to the fetus.
Breastfeeding
After oral administration of econazole nitrate to rats during lactation,
econazole and/or its metabolites have been excreted in milk and have been 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 operate machinery
None known.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Vaginal cream:
one applicator filled with cream every evening for two weeks.
Vaginal pessaries:
one pessary in the evening for two weeks.
Pregnant women should wash their hands thoroughly before self-administration of TROSYD GINECOLOGICO pessaries (for further information
see section “Special warnings”). In addition, regarding TROSYD
GINECOLOGICO cream, it is recommended that administration be carried out without
using the applicator, or that it be performed by the doctor.

OVERDOSE
Overdose with econazole nitrate has not been reported to date.
Given the available pharmaceutical forms, intended for vaginal application, cases of
acute overdose by ingestion are extremely unlikely and have never been reported so far. In
case of accidental ingestion, nausea, vomiting and diarrhea may occur. If necessary, treat
with symptomatic therapy.
In case of accidental ingestion/intake of an excessive dose of TROSYD
GYNECOLOGICAL, immediately notify a doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF TROSYD GYNECOLOGICAL, CONTACT
YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, TROSYD GYNECOLOGICAL can cause undesirable effects although
not all people will experience them.
The adverse reactions most frequently reported in clinical studies were reactions at the
application site, such as a burning sensation and stinging pain, itching and erythema.
Use of the product, especially if prolonged, may lead to sensitization phenomena. In
case of hypersensitivity reactions, it is necessary to discontinue treatment and establish
appropriate therapy; the same behavior must be adopted in case of development of
microorganisms that are not sensitive.
The following table lists the ADRs that have been reported with the use of the gynecological
formulation in clinical studies or in post-marketing experience, including the adverse reactions
mentioned above (ADRs - Adverse Drug Reactions).
The frequency classes are reported in accordance with the following convention:
very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1,000 to < 1/100); rare
(from ≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (the frequency cannot be
defined based on the available data from clinical studies).
All ADRs with known incidence (common or uncommon) come from clinical study data and all ADRs with unknown incidence come from post-marketing data.

Table 1: Drug-related adverse reactions (ADRs)

undesirable effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet,
contact your doctor or pharmacist. Adverse effects can also be reported directly through the
national reporting system at the address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting of adverse effects helps to provide more information on the
safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
WARNING: do not use the medicine after the expiry date indicated on the
packaging.
No special precautions for storage.
Medicines should not be disposed of via drains or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. This will help
to protect the environment.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

COMPOSITION
TROSYD GYNECOLOGICAL 1% vaginal cream:
100 g of cream contains:

Active ingredient:Econazole nitrate g 1.00

Excipients:Polyglycolic ester of saturated fatty acids, Propylene glycol, Methyl
parahydroxybenzoate, Propyl parahydroxybenzoate, Deionized water.
TROSYD GYNECOLOGICAL 50 mg vaginal suppositories:
One suppository contains:

Active ingredient:Econazole nitrate g 0.05

Excipients:Semisynthetic glycerides.

PHARMACEUTICAL FORM AND CONTENT
1% Vaginal cream – 1 Tube of 78 g with applicator
50 mg Suppositories – 15 suppositories

MARKETING AUTHORISATION HOLDER
Giuliani S.p.a. - Via Palagi, 2 - 20129 Milan

MANUFACTURER AND FINAL CONTROLLER
Special Product’s Line S.p.A.- Via Campobello, 15 - 00040 POMEZIA (Rome)

DRUG: