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TROSYD * EMULS CUT 30G 1%

  • Giuliani S.p.A.
  • 025647049
Trosyd 1% Cutaneous emulsion is a drug based on the active ingredient tioconazole (DC.IT) (FU), belonging to the category of antifungals and specifically imidazole and triazole derivatives. Trosyd 1% Cutaneous emulsion can be prescribed with OTC Recipe - self-medication. TROSYD 1% Cream - 1% Skin powder - 1% Skin emulsion Dermatomycosis caused by dermatophytes, yeasts and other fungi sensitive to thioconazole. Skin infections caused by drug-sensitive Gram-positive bacteria. Due to the concomitant antifungal and antibacterial activity, it is particularly indicated in mixed skin infections.TROSYD 28% Cutaneous solution for nail useOnicomycosis caused by dermatophytes and yeasts. Due to the concomitant antibacterial activity, it is particularly indicated in mixed nail infections. TroSyd 1% Cutaneous solution Topical antifungal treatment of skin infections caused by fungi (dermatophytes and yeasts), even if associated with superinfections with Gram-positive bacteria sensitive to the drug, as adjuvant to therapy with other specific topical preparations. The skin solution allows greater ease of application in the most extensive dermatomycoses and performs a medicated cleansing of hairless or hairy skin.Moreover, by allowing the treatment of a large skin surface, it makes it possible to eliminate the pathogen not only where they are detectable skin morphological variations but also where the skin is apparently healthy.
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TROSYD * EMULS CUT 30G 1%

Therapeutic indications

TROSYD 1% Cream - 1% Skin powder - 1% Skin emulsionDermatomycosis caused by dermatophytes, yeasts and other fungi sensitive to tioconazole. Skin infections caused by drug-sensitive Gram-positive bacteria. Due to the concomitant antifungal and antibacterial activity, it is particularly indicated in mixed skin infections.TROSYD 28% Cutaneous solution for nail useOnychomycosis caused by dermatophytes and yeasts. Due to the concomitant antibacterial activity, it is particularly indicated in mixed nail infections.TROSYD 1% Cutaneous solutionTopical antifungal treatment of skin infections caused by fungi (dermatophytes and yeasts), even if associated with superinfections with drug-sensitive Gram-positive bacteria, as an adjunct to therapy with other specific topical preparations. The skin solution allows greater ease of application in the most extensive dermatomycoses and performs a medicated cleansing of the hairless or hairy skin. Furthermore, allowing the treatment of a large skin surface, it makes it possible to eliminate the pathogen not only where skin morphological changes are detectable but also where the skin is apparently healthy.

Dosage and method of use

Dosage TROSYD1% Cream - 1% Powder - 1% Skin emulsion The medicine should be applied with a light massage twice a day, morning and evening, on the affected skin and on that immediately surrounding it. The duration of treatment required to achieve healing varies from patient to patient and in relation to the infecting agent and site of infection. A 7-day treatment is usually sufficient to achieve healing in most patients withPityriasis versicolor, while it may take up to 6 weeks of treatment in case of severe forms ofTinea pedis(athlete's foot), especially with regard to the chronic hyperkeratotic clinical variety. The duration of treatment required for dermatophytic infections at other locations (body, skin folds) for Candidiasis and Erythrasma is usually between 2 and 4 weeks. Trosyd 28% Cutaneous solution for nail use The medicine should be applied on the infected nail and in the periungual region twice a day, morning and evening, using the special brush. The duration of treatment required to achieve healing varies from patient to patient, and is related to the infecting agent and extent of the lesion. Generally, therapy can last up to 6 months on average, but can be extended up to a year. Trosyd 1% Cutaneous solution The medicine should be applied once a day. The use of TROSYD 1% cutaneous solution must be carried out together with concomitant specific topical antifungal treatment, applied after the use of the solution. The duration of treatment required to achieve healing varies with the infecting agent and site of infection and is usually between two and four weeks. In the opinion of the doctor, treatment with the cutaneous solution can be continued even after the end of other specific topical therapies in order to reduce the risk of relapse. Pediatric population There are no data on the safety and efficacy of TROSYD in children and adolescents.Method of administration Trosyd 1% Cream - 1% Powder - 1% Skin emulsion - In the areas of intertrigoTROSYD 1% Creamit should be applied in small quantities and well spread, to avoid maceration phenomena. -TROSYD 1% Skin powderit is available in a container with which it can be directly applied in a uniform layer. -TROSYD 1% Skin emulsionit should be applied with the fingertips and with a cotton swab. Trosyd 28% Cutaneous solution for nail use The solvent contained in Trosyd dries in 5 minutes leaving a thin transparent and oily film. Even if this film is randomly removed this does not decrease the drug's activity, and therefore it is not necessary to apply it again. It is recommended not to use an occlusive dressing. Trosyd 1% Cutaneous solution It should be applied as a liquid detergent, and it should be rinsed with water waiting a few minutes. Use the amount of solution necessary in relation to the skin surface to be treated, because in contact with the skin it forms a foamy solution.

Contraindications

Hypersensitivity to the active substance or to any of the other ingredients of this medicinal product listed in section 6.1.Trosyd 1% Cutaneous solution is contraindicated inpregnancy (see section 4.6).

Side effects

In very rare cases a slight and transient local irritation has been observed. However, in the presence of hypersensitivity reactions, treatment should be discontinued and appropriate therapy instituted.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows for continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

The application of topical medicines, especially if prolonged, can give rise to sensitization phenomena.Important information about some of the ingredients: TROSYD 1% Cream - 1% Skin emulsion contain cetostearyl alcohol which can cause local skin reactions (eg contact dermatitis).TROSYD 1% Skin emulsion contains propylene glycol which may cause skin irritation.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.Trosyd 28% cutaneous solution for nail use: although systemic absorption after topical administration is negligible, however, as the treatment of onychomycosis can last for many months, the use of Trosyd cutaneous solution for nail use in pregnancy is contraindicated.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interactions or incompatibilities with other medicines are known so far

Overdose

No cases of overdose have been reported so far.

Active principles

TROSYD 1% Cream1 g of cream contains:Active principle:Tioconazole 10 mgTROSYD 1% Skin powder100 g of powder contain:Active principle:Tioconazole 1 gTROSYD 1% Skin emulsion100 g of emulsion contain:Active principle:Tioconazole 1 gTROSYD 28% Cutaneous solution for nail use100 g of solution contain:Active principle:Tioconazole 28 gTROSYD 1% Cutaneous solutionEach 10 g sachet of solution contains:Active principle:Tioconazole 0.10 g Excipients with known effects: cetostearyl alcohol and propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Trosyd 1% Cream: polysorbate 60, sorbitan monostearate, cetostearyl alcohol, 2-octyldodecanol, cetyl ester wax, benzyl alcohol, purified water.Trosyd 1% Skin powder:talc, magnesium myristate, kaolin, precipitated silica.Trosyd 1% Skin emulsion: emulsifying wax, cetyl alcohol, cetylstearyl alcohol, coconut oil, glycerylstearate and palmitate, propylene glycol, benzyl alcohol, purified water.Trosyd 28% Cutaneous solution for nail use: undecylenic acid, ethyl acetate.Trosyd 1% Cutaneous solution:monoethanolamine lauryl sulfate, lecithinamide, polyglycollum, undebenzophene, lactic acid, soothing lipoessential, purified water.

025647049

Data sheet

Packaging
1% skin emulsion 30 g
Product Type
HUMAN DRUG
ATC code
D01AC07
ATC description
Tioconazole
Therapeutic Group
Antifungals
Active principle
tioconazole (DC.IT) (FU)
Class
C.
Pharmaceutical form
emulsion
Type of Administration
topical
Container
bottle
Quantity
1 vial / vial / vial
Capacity
30 grams
Quantity of the Active Ingredient
1G
Recipe required
OTC - self-medication medicine
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