Trosyd: detailed information

Package leaflet: Information for the user

TROSYD 28%

Tioconazole
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What TROSYD is and what it is used for
What you need to know before using TROSYD
How to use TROSYD
Possible side effects
How to store TROSYD
Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active substance tioconazole, an antifungal agent used for the treatment of fungal nail infections such as:

Onychomycosis caused by dermatophytes and yeasts
Mixed nail infections due to its concomitant antibacterial activity (against bacteria).

Consult your doctor if you do not notice any improvement or if you observe worsening of symptoms after a short period of treatment.

2. WHAT YOU SHOULD KNOW BEFORE USING TROSYD

Do not use TROSYD

If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine listed in section 6.
During pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using TROSYD.
The use of topical medicines, especially if prolonged, may lead to allergic reactions (hypersensitivity).

Children and adolescents
There are no data regarding the safety and efficacy of TROSYD in children and adolescents; consult your doctor.

Other medicines and TROSYD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicinal products are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use TROSYD during pregnancy, since, although absorption of the medicine after application to the nails is negligible, treatment may last for many months.

Driving and using machines
No effects of TROSYD on the ability to drive vehicles or operate machinery have been reported.

3. HOW TO USE TROSYD

Use this medicinal product exactly as described in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply TROSYD to the infected nail and the periungual area (around the nail) twice daily, in the morning and evening, using the brush provided in the cap.
The solvent in TROSYD dries within 5 minutes, leaving a thin, transparent, oily film. Even if this film is accidentally removed, the drug's activity is not reduced.
The use of an occlusive dressing is not recommended.
Caution: Do not exceed the recommended doses without medical advice.
The duration of treatment required to achieve healing varies from patient to patient and depends on the infecting agent and the extent of the lesion.
Generally, treatment may last on average up to 6 months, but may be extended up to one year.
If you use more TROSYD than you should
No cases of overdose have been reported.
In case of accidental ingestion/absorption of TROSYD, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very rare adverse reactions (may affect up to 1 in 10,000 patients)
Mild and transient local skin irritation.
In case of allergic reactions (hypersensitivity), treatment must be discontinued and appropriate therapy initiated.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TROSYD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the carton and the
package leaflet.

6. PACK CONTENTS AND OTHER INFORMATION

What TROSYD contains
100 g of solution contains:
Active substance: Tioconazole 28 g
Other components: Undecylenic acid, Ethyl acetate.
Description of the appearance of TROSYD and pack contents
Cutaneous solution.
Bottle containing 12 ml of 28% cutaneous solution for topical nail use.
Marketing Authorization Holder
Giuliani S.p.A
Via Palagi, 2 – 20129 Milan, Italy
Manufacturers
Farmasierra Manufacturing S.L. – Ctra de Irun, km 26200 – 28700 San Sebastian de los Reyes, Madrid, Spain.
Doppel Farmaceutici – via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC), Italy

Package leaflet: information for the user

TROSYD 1% CUTANEOUS SPRAY, SOLUTION

Tioconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What TROSYD is and what it is used for
What you need to know before using TROSYD
How to use TROSYD
Possible side effects
How to store TROSYD
Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active substance tioconazole, an antifungal agent used to treat fungal skin infections such as:

Dermatomycoses caused by dermatophytes, yeasts, and other fungi sensitive to tioconazole
Mixed skin infections due to its combined antifungal (against fungi) and antibacterial (against bacteria) activity.

Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

2. WHAT YOU NEED TO KNOW BEFORE USING TROSYD

Do not use TROSYD
If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine
listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using TROSYD.
The application of topical medicines, especially if prolonged, may lead to allergic reactions
(hypersensitivity).
Avoid spraying the medicine into the eyes.
Children and adolescents
There are no data available regarding the safety and efficacy of TROSYD in children and adolescents; consult your doctor.
Other medicines and TROSYD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. No interactions with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use TROSYD only after consulting your doctor and having evaluated with him
the risk/benefit ratio in your individual case.
Driving and using machines
No effects of TROSYD on the ability to drive or operate machinery have been reported.

3. HOW TO USE TROSYD

Use this medicinal product exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions.
If you have any doubts, consult your doctor or pharmacist.
Apply the medicine twice daily (once in the morning and once in the evening) by evenly spraying it onto the affected area.

TROSYD 1% Cutaneous Spray, solution is particularly useful for treating hairy skin areas and skin folds. It is also indicated to facilitate application over large body areas (back, abdomen, chest). It can also be used with the container in an inverted position.
Caution: Do not exceed the recommended doses without medical advice.
The duration of treatment required to achieve healing varies from patient to patient, depending on the infecting agent and the site of infection.

Pityriasis versicolor (fungal infection causing light brown spots, usually 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 necessary, especially for the chronic hyperkeratotic clinical form (thickening of the skin).
Fungal infections at other sites (body, skin folds), candidiasis, and erythrasma (bacterial infection): the required duration of treatment is usually between 2 and 4 weeks. Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics.

If you use more TROSYD than you should
No cases of overdose have been reported. In case of accidental ingestion/ingestion of TROSYD, inform your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Very rare adverse reactions (may affect up to 1 in 10,000 patients):
Mild and transient local skin irritation.
In case of allergic reactions (hypersensitivity), treatment must be discontinued and appropriate therapy initiated.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE TROSYD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the packaging and the
package leaflet.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What TROSYD contains
1 g of cutaneous spray solution contains:
Active substance: Tioconazole: 10 mg
Other components: Myristyl isopropylate, Isopropyl alcohol

Description of the appearance of TROSYD and packaging contents
Cutaneous spray, solution.
Spray bottle containing 30 g of 1% solution.

Marketing Authorization Holder
Giuliani S.p.A.
Via Palagi, 2 - 20129, Milan, Italy

Manufacturer
Zellaerosol GmbH
Wiesenstrasse 13
D-79669 Zell in Wiesental (Germany)

Package leaflet: information for the user

TROSYD 1% CREAM, 1% CUTANEOUS POWDER, 1% CUTANEOUS EMULSION

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What TROSYD is and what it is used for
What you need to know before using TROSYD
How to use TROSYD
Possible side effects
How to store TROSYD
Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active substance tioconazole, an antifungal agent used to treat fungal skin infections such as:

Dermatomycoses caused by dermatophytes, yeasts, and other fungi sensitive to tioconazole
Skin infections caused by Gram-positive bacteria sensitive to the drug
Mixed skin infections due to its combined antifungal (against fungi) and antibacterial (against bacteria) activity.

Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

2. WHAT YOU SHOULD KNOW BEFORE USING TROSYD

Do not use TROSYD
If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine
listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using TROSYD.
The application of topical medicines, especially if prolonged, may lead to allergic reactions
(hypersensitivity).
Children and adolescents
There are no data available on the safety and efficacy of TROSYD in children and adolescents; consult your doctor.
Other medicines and TROSYD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use TROSYD only after consulting your doctor and evaluating with him
the risk/benefit ratio in your specific case.
Driving and using machinery
No effects of TROSYD on the ability to drive vehicles or operate machinery have been reported.
TROSYD 1% cream and 1% emulsion contain cetyl stearyl alcohol (also known as cetyl alcohol).
It may cause local skin reactions (e.g. contact dermatitis).
TROSYD 1% cutaneous emulsion contains propylene glycol. It may cause skin irritation.

3. HOW TO USE TROSYD

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of the medicine twice daily (once in the morning and once in the evening) by gently
massaging it into the affected skin and the surrounding area.
Caution: Do not exceed the recommended doses without medical advice.
TROSYD 1% Cream: apply the medicine by gently massaging it into the affected skin and the surrounding area.
In intertriginous areas (skin folds), apply the medicine in small amounts and spread it well to avoid maceration.
TROSYD 1% Cutaneous Powder: the medicine is supplied in a container that allows direct application in an even layer to the affected skin and the surrounding area.
TROSYD 1% Cutaneous Emulsion: apply the medicine by gently massaging with the fingertips or using a cotton swab onto the affected skin and the surrounding area.
The duration of treatment required to achieve healing varies from patient to patient, depending on the infecting agent and the site of infection.

Pityriasis versicolor (a fungal infection causing light brown spots, usually 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 necessary, especially for the chronic hyperkeratotic clinical form (thickening of the skin).
Fungal infections at other sites (body, skin folds), candidiasis, and erythrasma (a bacterial infection): the required duration of treatment is usually between 2 and 4 weeks.

Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics.
If you use more TROSYD than you should
Cases of overdose have not been reported.
In case of accidental ingestion/ingestion of TROSYD, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very rare adverse reactions (may affect up to 1 in 10,000 patients):
Mild and transient local skin irritation.
In the event of allergic reactions (hypersensitivity), treatment must be discontinued and appropriate therapy initiated.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TROSYD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.

6. PACK CONTENTS AND OTHER INFORMATION

What TROSYD contains
TROSYD 1% Cream
Each gram of cream contains:
Active substance: Tioconazole: 10 mg
Other components: Polysorbate 60, Sorbitan monostearate, Cetyl alcohol, 2-Octyldodecanol, Cetyl ester wax, Benzyl alcohol, Purified water.

TROSYD 1% Cutaneous Powder
100 g of powder contain:
Active substance: Tioconazole: 1 g
Other components: Talc, Magnesium myristate, Kaolin, Precipitated silica.

TROSYD 1% Cutaneous Emulsion
100 g of emulsion contain:
Active substance: Tioconazole: 1 g
Other components: Emulsifying wax, Cetyl alcohol, Cetostearyl alcohol, Coconut oil, Glyceryl stearate and palmitate, Propylene glycol, Benzyl alcohol, Purified water.

Description of TROSYD appearance and pack contents
TROSYD 1% Cream
Cream. Tube of 30 g.

TROSYD 1% Cutaneous Powder
Cutaneous powder. Bottle of 30 g.

TROSYD 1% Cutaneous Emulsion
Cutaneous emulsion. Bottle of 30 g.

Marketing Authorization Holder
Giuliani S.p.A
Via Palagi, 2 - 20129, Milan, Italy

Manufacturer of the cream
Doppel Farmaceutici S.r.l.
Via Martiri Delle Foibe, 1 - 29016 Cortemaggiore (PC), Italy

Manufacturer of the powder and cutaneous emulsion
Haupt Pharma Latina S.r.l.
S.S. 156, Km 50 - 04010
Borgo San Michele (LT), Italy

Package leaflet: information for the user

TROSYD 1% CUTANEOUS SOLUTION

Tioconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What TROSYD is and what it is used for
What you need to know before using TROSYD
How to use TROSYD
Possible side effects
How to store TROSYD
Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active substance tioconazole, an antifungal agent used:

For the treatment of fungal skin infections caused by dermatophytes and yeasts, even when associated with superinfections by Gram-positive bacteria sensitive to the medicinal product.
As an adjunct (to assist) to therapy with other specific topical preparations.

The cutaneous solution allows easier application in more extensive cases of dermatomycosis (fungal skin infections) and provides medicated cleansing of glabrous or hairy skin.
Moreover, by enabling treatment over a large skin surface area, it allows elimination of the pathogen not only where morphological (structural) skin changes are evident, but also where the skin appears apparently healthy.
Consult your doctor if you do not notice any improvement or if you observe worsening of symptoms after a short period of treatment.

2. WHAT YOU NEED TO KNOW BEFORE USING TROSYD

Do not use TROSYD
If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicinal product listed in section 6.

Warnings and precautions
Talk to your doctor or pharmacist before using TROSYD.
The application of topical medicines, especially if prolonged, may lead to allergic reactions (hypersensitivity).
The cutaneous solution is an adjunctive product (one that helps) and, as such, should always be used in combination with topical therapy using a specific product (creams, lotions, powders).

Children
There are no data regarding the safety and efficacy of TROSYD in children and adolescents; consult your doctor.

Other medicines and TROSYD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicinal product.
If you are pregnant or breastfeeding, use TROSYD only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.

Driving and using machines
No effects of TROSYD on the ability to drive vehicles and use machinery have been reported.

3. HOW TO USE TROSYD

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply TROSYD once daily as a liquid cleanser, leaving it on the skin for a few minutes before rinsing thoroughly with water.
Use the amount of solution appropriate for the size of the skin area to be treated, as it forms a foamy solution upon contact with the skin.
Caution: Do not exceed the recommended doses without medical advice.
The use of TROSYD 1% cutaneous solution should be combined with concomitant topical antifungal treatment, applied after using the solution.
The duration of treatment required to achieve healing depends on the infecting agent and the site of infection, and usually ranges between 2 and 4 weeks.
At the physician’s discretion, treatment with the solution may be continued even after completion of other specific topical therapies, in order to reduce the risk of recurrence.
If you use more TROSYD than you should
No cases of overdose have been reported.
In case of accidental ingestion/ingestion of TROSYD, inform your doctor immediately or go to the nearest hospital.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very rare adverse reactions (may affect up to 1 in 10,000 patients)
Mild and transient local skin irritation.
In case of allergic reactions (hypersensitivity), treatment must be discontinued and appropriate therapy initiated.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TROSYD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to safely discard medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What TROSYD contains
Each 10 g sachet of solution contains:
Active substance: Tioconazole: 100 mg
Other components: Monoethanolamine lauryl sulfate; Lecithinamide; Polyglycol; Undecylenic acid benzylidene; Lactic acid;
Liposomal soothing complex; Purified water.
Description of the appearance of TROSYD and contents of the pack
Cutaneous solution.
Pack containing 6 sachets of 10 grams of solution each.
Marketing Authorization Holder
Giuliani S.p.A.
Via Palagi 2 - 20129 Milan
Manufacturer
Haupt Pharma Latina S.r.l
Borgo San Michele S.S. 156 km. 47,600
04010 Latina