Trosyd - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Tioconazole

TROSYD 1% Cream (tioconazole)
TROSYD 1% Skin powder (thioconazole)
TROSYD 1% Skin emulsion (tioconazole)

Trosyd package inserts are available for pack sizes:
  • TROSYD 1% Cream (tioconazole), TROSYD 1% Skin powder (thioconazole), TROSYD 1% Skin emulsion (tioconazole)
  • TROSYD 28% Cutaneous solution for nail use (tioconazole)
  • TROSYD 1% Cutaneous solution (tioconazole)

Indications Why is Trosyd used? What is it for?

TROSYD is a topical antifungal and is used to treat infections caused by skin fungi.

WHY IT IS USED

TROSYD is used for Dermatomycosis caused by dermatophytes, yeasts and other fungi (infections caused by skin fungi) sensitive to Tioconazole. Drug-sensitive Gram-positive bacterial skin infections. Due to the concomitant antifungal and antibacterial activity, it is particularly indicated in mixed skin infections.

Contraindications When Trosyd should not be used

Hypersensitivity to the active substance or to any of the excipients.

Precautions for use What you need to know before you take Trosyd

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

Pregnancy and breastfeeding (see "WHAT TO DO DURING PREGNANCY AND" BREASTFEEDING ")

Interactions Which drugs or foods can modify the effect of Trosyd

There are no known interactions with other drugs, but if you are using other medicines ask your doctor or pharmacist for advice.

Warnings It is important to know that:

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

During pregnancy and / or breastfeeding, TROSYD should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.

Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.

It is important to know that:

The application of products for topical use, especially if prolonged, can give rise to sensitization phenomena.

Dose, Method and Time of Administration How to use Trosyd: Posology

How many

The product should be applied in a thin layer by lightly massaging the affected skin and that immediately surrounding it. Warning: do not exceed the indicated doses without medical advice.

When and for how long

2 applications per day: one in the morning and one in the evening. The duration of treatment required to achieve healing varies from patient to patient and in relation to the infecting agent and site of infection.

  • Pityriasis versicolor (fungal infection that occurs with coffee-and-milk-colored spots, generally located on the trunk): a 7-day treatment is usually sufficient to achieve healing in most patients.
  • Tinea pedis (athlete's foot): up to 6 weeks of treatment may be required especially for the chronic hyperkeratotic variety
  • Mycosis at other locations (body, skin folds), candidiasis and erythrasma: the duration of the required treatment is usually between 2 and 4 weeks.

Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.

Like

  • TROSYD 1% Cream: the product should be applied by gentle massage on the affected skin and that immediately surrounding it. In the areas of intertrigo (skin folds) the product should be applied in small quantities and well spread to avoid maceration phenomena.
  • TROSYD 1% Skin powder: the product is available in a container with which it can be directly applied in a uniform layer on the affected skin and the one immediately surrounding it.
  • TROSYD 1% Skin emulsion: the product should be applied by gentle massage with the fingertips or with a cotton swab on the affected skin and the one immediately surrounding it.

Overdose What to do if you have taken too much Trosyd

No cases of overdose have been reported.

In case of accidental ingestion / intake of Trosyd, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Trosyd

In very rare cases, mild and transient local irritation has been observed. However, in the presence of hypersensitivity reactions, treatment should be discontinued and appropriate therapy instituted.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet. Request and fill in the Undesirable Effects report form available at the pharmacy (form B).

Expiry and Retention

Warning: do not use the medicine after the expiry date indicated on the package. Keep this medicine out of the reach of children

It is important to always have the information about the medicine available, so keep both the box and the package leaflet.

COMPOSITION

TROSYD 1% Cream

1 g of cream contains:

Active ingredient: Tioconazole: 10 mg

Excipients: Polysorbate 60; Sorbitan monostearate; Cetostearyl alcohol; 2-Octyldodecanol; Cetyl ester wax; Benzyl alcohol; Purified water.

TROSYD 1% Skin powder

100 g of powder contain:

Active ingredient: Tioconazole: 1 g

Excipients: Talc; Magnesium myristate; Kaolin; Precipitated silica.

TROSYD 1% Skin emulsion

100 g of emulsion contain:

Active ingredient: Tioconazole: 1 g

Excipients: Emulsifying wax; Cetyl alcohol; Cetylstearyl alcohol; Coconut oil Glycerylstearate and palmitate; Propylene glycol; Benzyl alcohol; Purified water.

HOW IT LOOKS

  • TROSYD 1% CREAM comes in the form of a 1% cream in a 30 gram tube.
  • TROSYD 1% SKIN POWDER comes in the form of 1% powder in a 30 gram bottle.
  • TROSYD 1% SKIN EMULSION comes in the form of a 1% milky emulsion in a 30 gram bottle.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Trosyd can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TROSYD

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

TROSYD 1% Cream

1 g of cream contains:

Active principle:

Tioconazole 10 mg.

TROSYD 1% Skin powder

100 g of powder contain:

Active principle:

Tioconazole 1 g.

TROSYD 1% Skin emulsion

100 g of emulsion contain:

Active principle:

Tioconazole 1 g.

TROSYD 28% Cutaneous solution for nail use

100 g of solution contain:

Active principle:

Tioconazole 28 g.

TROSYD 1% Cutaneous solution

Each 10 g sachet of solution contains:

Active principle:

Tioconazole 0.10 g.

03.0 PHARMACEUTICAL FORM

Cream.

Skin powder.

Skin emulsion.

Cutaneous solution for nail use.

Skin solution

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

TROSYD 1% Cream - 1% Skin powder - 1% Skin emulsion

Dermatomycosis sustained by dermatophytes, yeasts and other fungi sensitive to Tioconazole. Drug-sensitive Gram-positive bacterial skin infections. Due to the concomitant antifungal and antibacterial activity, it is particularly indicated in mixed skin infections.

TROSYD 28% Cutaneous solution for nail use

Onychomycosis sustained by dermatophytes and yeasts. Due to the concomitant antibacterial activity, it is particularly indicated in mixed infections.

TROSYD 1% Cutaneous solution

TROSYD cutaneous solution is indicated in the topical treatment of skin infections caused by fungi (dermatophytes and yeasts), even if associated with superinfections by Gram-positive bacteria sensitive to it, 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, by 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.

04.2 Posology and method of administration

1% Cream - 1% Powder - 1% Skin emulsion

TROSYD should be applied with a light massage twice a day, morning and evening, on the affected skin and on the immediately surrounding one.

• In areas of intertrigo TROSYD 1% Cream it should be applied in small quantities and well spread, to avoid maceration phenomena.

TROSYD 1% Skin powder it is available in a container with which it can be directly applied in a uniform layer.

TROSYD 1% Skin emulsion it should be applied with the fingertips and with a cotton swab.

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 with Pityriasis versicolor, while it may take up to 6 weeks of treatment in case of severe forms of Tinea pedis (athlete's foot), especially with regard to the chronic hyperkeratotic clinical variety. The duration of treatment required for dermatophytic infections at other locations for Candidiasis and Erythrasma is usually between 2 and 4 weeks.

Trosyd 28% Cutaneous solution for nail use: TROSYD should be applied on the infected nail and in the periungual region twice a day, morning and evening, using the special brush. 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 activity of the drug, and therefore it is not necessary to apply it again. It is recommended not to use an occlusive dressing. The duration of treatment required to achieve healing varies from patient to patient, and it is related to the infectious agent and the extent of the lesion. In general, therapy can last an average of up to 6 months, but can be prolonged up to a year.

Trosyd 1% Cutaneous solution: In contact with the skin it forms a foamy solution: use the amount of solution necessary in relation to the skin surface to be treated, using the product as a liquid detergent, once a day, and rinse with water a few minutes after application. 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 according to the infecting agent and the 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.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy (for Trosyd cutaneous solution for nail use): see point 4.6.

04.4 Special warnings and appropriate precautions for use

The application of products for topical use, especially if prolonged, can give rise to sensitization phenomena.

04.5 Interactions with other medicinal products and other forms of interaction

No interactions or incompatibilities with other medicaments are known so far.

04.6 Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. 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 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.

04.7 Effects on ability to drive and use machines

No effect of TROSYD on the ability to drive and use machines has been reported, nor is it conceivable.

04.8 Undesirable 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.

04.9 Overdose

No cases of overdosing have been reported so far.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: antifungals for topical use.

ATC code: D01AC07.

TROSYD is a powerful, broad spectrum imidazole antifungal, which has shown in vitro a "fungicidal activity against yeasts such as Candida albicans and other species of Candida, of pathogenic dermatophytes and other fungi, also endowed with antibacterial activity against some Gram-positive germs, with anti-Trichomonas and anti-Gardnerella vaginalis, useful properties in the therapy of mixed infections.

05.2 Pharmacokinetic properties

Studies in both animals and humans have shown that cutaneous application of TROSYD does not result in clinically significant absorption.

05.3 Preclinical safety data

Toxicological tests carried out in various animal species have shown that TROSYD is well tolerated, devoid of photosensitizing, teratogenic and mutagenic activity. The oral LD50 is 325 mg / kg in rats and 380 mg / kg in mice.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

1% Cream: polysorbate 60, sorbitan monostearate, cetostearyl alcohol, 2-octyldodecanol, cetyl ester wax, benzyl alcohol, purified water.

1% Skin powder: talc, magnesium myristate, kaolin, precipitated silica.

1% Skin emulsion: emulsifying wax, cetyl alcohol, cetylstearyl alcohol, coconut oil, glycerylstearate and palmitate, propylene glycol, benzyl alcohol, purified water.

28% Cutaneous solution for nail use: undecylenic acid, ethyl acetate.

1% Cutaneous solution: monoethanolamine lauryl sulfate, lecithinamide, polyglycollum, undebenzophen, lactic acid, soothing lipoessential, purified water.

06.2 Incompatibility

Not relevant.

06.3 Period of validity

28% Cutaneous solution for nail use: 36 months.

All other formulations: 24 months.

06.4 Special precautions for storage

No particular precautions for storage.

06.5 Nature of the immediate packaging and contents of the package

TROSYD 1% Cream: flexible aluminum tube of 30 grams.

TROSYD 1% Skin powder: 30 gram polyethylene bottle.

TROSYD 1% Skin emulsion: 30 gram polyethylene container.

TROSYD 28% Cutaneous solution for nail use: bottle of 12 ml.

TROSYD 1% Cutaneous solution: pack of 6 sachets of 10 grams.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

Giuliani Spa

Via Palagi, 2 - 20129 Milan

08.0 MARKETING AUTHORIZATION NUMBER

TROSYD 1% Cream: AIC n .: 025647013

TROSYD 1% Skin powder: AIC n .: 025647037

TROSYD 1% Skin emulsion: AIC n .: 025647049

TROSYD 28% Cutaneous solution for nail use: AIC n .: 025647114

TROSYD 1% Cutaneous solution AIC n .: 025647138

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

May 31, 2000

10.0 DATE OF REVISION OF THE TEXT

November 24, 2009

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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