TROSYD 1% Cream

Зміст інструкції

1. TROSYD 28%
   1. WHAT IS TROSYD AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TROSYD
   3. HOW TO USE TROSYD
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TROSYD
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
2. TROSYD 1% CUTANEOUS SPRAY, SOLUTION
   1. WHAT TROSYD IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TROSYD
   3. HOW TO USE TROSYD
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TROSYD
   6. PACKAGE CONTENTS AND OTHER INFORMATION
   7. WHAT TROSYD IS AND WHAT IT IS USED FOR
   8. WHAT YOU NEED TO KNOW BEFORE USING TROSYD
   9. HOW TO USE TROSYD
   10. POSSIBLE SIDE EFFECTS
   11. HOW TO STORE TROSYD
   12. CONTENTS OF THE PACK AND OTHER INFORMATION
3. TROSYD 1% CUTANEOUS SOLUTION
   1. WHAT TROSYD IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TROSYD
   3. HOW TO USE TROSYD
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TROSYD
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

TROSYD 28%

Tioconazole

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after a short period of treatment.

Contents of this leaflet:

• 1. What TROSYD is and what it is used for
• 2. What you need to know before you use TROSYD
• 3. How to use TROSYD
• 4. Possible side effects
• 5. How to store TROSYD
• 6. Contents of the pack and other information

1. WHAT IS TROSYD AND WHAT IT IS USED FOR

TROSYD contains the active ingredient tioconazole, an antifungal used for the treatment of nail infections caused by fungi such as:

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

Consult your doctor if you do not notice any improvement or if your symptoms worsen 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 ingredient or to any of the other ingredients of this medicine listed in section 6.
• During pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using TROSYD.
Application of topical medicines, especially if prolonged, may cause allergic reactions
(hypersensitivity).

Children and adolescents
There is 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 drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.
Do not use TROSYD during pregnancy because, even if the absorption of the medicine after application on the
nails is negligible, the therapy may last for many months.

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

3. HOW TO USE TROSYD

Use this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply TROSYD to the infected nail and in the periungual region (around the nail) 2 times a day, morning and
evening, using the special brush attached to the cap.
The solvent contained in TROSYD dries in 5 minutes leaving a thin, transparent and oily film. Even if
this film is accidentally removed, this does not decrease the activity of the drug.
It is recommended not to use an occlusive bandage.

Warning: do not exceed the indicated doses without the advice of your doctor.
The duration of treatment required to achieve healing varies from patient to patient and in relation to the infecting
agent and the extent of the lesion.
Generally, therapy can last on average up to 6 months, but may be prolonged up to one year.

If you use more TROSYD than you should
No cases of overdose have been reported.
In case of accidental ingestion/intake of TROSYD, immediately inform your doctor or go to the nearest
hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people)
Mild and transient local skin irritation.
If allergic reactions (hypersensitivity) occur, treatment should be discontinued and appropriate therapy
initiated.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist.
You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects 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 which is stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 have the information about the medicine available, therefore keep both the box and the

6. CONTENTS OF THE PACK 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 contents of the pack
Cutaneous solution.
Bottle containing 12 ml of cutaneous solution for nail use at 28%.

Marketing Authorisation Holder
Giuliani S.p.A
Via Palagi, 2 – 20129 Milano

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)

TROSYD 1% CUTANEOUS SPRAY, SOLUTION

Tioconazole

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What TROSYD is and what it is used for
• 2. What you need to know before you use TROSYD
• 3. How to use TROSYD
• 4. Possible side effects
• 5. How to store TROSYD
• 6. Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active ingredient tioconazole, an antifungal used for the treatment of skin infections caused by fungi such as:

• Dermatophytoses caused by dermatophytes, yeasts and other fungi sensitive to tioconazole
• Mixed skin infections due to the concomitant antifungal (against fungi) and antibacterial (against bacteria) activity. Consult your doctor if you do not notice any improvement or if your symptoms worsen 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 ingredient or to any of the other ingredients of this medicine
listed in section 6.

Warnings and precautions
Consult your doctor or pharmacist before using TROSYD.
Application of topical medicines, especially if prolonged, may cause allergic
(hypersensitivity) reactions.
Avoid spraying the medicine into your eyes.

Children and adolescents
There is 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 drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you 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/her
the risk/benefit ratio in your case.

Driving and operating machinery
No effects of TROSYD on the ability to drive and operate machinery have been reported.

3. HOW TO USE TROSYD

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or
pharmacist.
If you have any doubts, ask your doctor or pharmacist.
Apply twice a day (once in the morning and once in the evening) by spraying the medicine evenly onto the area to be
treated.
TROSYD 1% Cutaneous Spray, solution is particularly useful for treating skin areas covered with hair and in
skin folds. It is also indicated to facilitate application to large areas of the body
(back, abdomen, chest). It can also be used with the can inverted.

Warning: do not exceed the indicated doses without your doctor's 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 manifesting as coffee-with-milk coloured 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 variety (skin thickening).
• Fungal infections in other locations (body, skin folds), candidiasis and erythrasma(bacterial infection): the duration of treatment required is usually between 2 and 4 weeks. Consult your doctor if the condition recurs or if you have noticed any recent change in its characteristics. If you use more TROSYD than you shouldNo cases of overdose have been reported. In case of accidental ingestion/intake of TROSYD, immediately inform your doctor or go to the nearest hospital.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people)
Mild and transient local skin irritation.
If allergic reactions (hypersensitivity) occur, treatment should be discontinued and appropriate therapy initiated.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects 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 which is stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the box and the

6. PACKAGE CONTENTS AND OTHER INFORMATION

What TROSYD contains
1 g of cutaneous spray solution contains:

Active ingredient: Tioconazole: 10 mg

Other ingredients: Isopropyl myristate, Isopropyl alcohol

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

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

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

TROSYD1% CREAM
TROSYD1% CUTANEOUS POWDER
TROSYD1% CUTANEOUS EMULSION
Tioconazole

Read this leaflet carefully before you start using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after a short period of treatment.

Contents of this leaflet:

• 1. What TROSYD is and what it is used for
• 2. What you need to know before you use TROSYD
• 3. How to use TROSYD
• 4. Possible side effects
• 5. How to store TROSYD
• 6. 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 used for the treatment of fungal skin infections such as:

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

Contact your doctor if you do not notice any improvement or if your symptoms worsen 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 ingredient or to any of the other ingredients of this medicine
listed in section 6.

Warnings and precautions
Consult your doctor or pharmacist before using TROSYD.
Application of topical medicines, especially if prolonged, may cause allergic reactions
(hypersensitivity).

Children and adolescents
There is 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 drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you 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 case.

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

TROSYD 1% cream and 1% emulsion contain cetostearyl alcohol (also called cetyl stearyl 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 following 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 twice a day (once in the morning and once in the evening) a thin layer of the medicine with gentle
massage on the affected skin and the immediately surrounding area.

Warning: do not exceed the indicated doses without the advice of your doctor.
TROSYD 1% Cream: apply the medicine with gentle massage on the affected skin and the immediately
surrounding area.
In areas of intertrigo (skin folds), the medicine should be applied in small amounts and spread well to
avoid maceration.
TROSYD 1% Cutaneous powder: the medicine is available in a container with which it can be directly
applied in a uniform layer on the affected skin and the immediately surrounding area.
TROSYD 1% Cutaneous emulsion: apply the medicine with gentle massage with the fingertips or
with a cotton swab on the affected skin and the immediately 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(fungal infection that manifests with coffee-with-milk colored spots, usually located on the trunk): a treatment of 7 days is usually sufficient to achieve healing in most patients.
• Tinea pedis(athlete's foot): up to 6 weeks of treatment may be necessary, especially regarding the chronic hyperkeratotic clinical variety (skin thickening).
• Fungal infections at other sites (body, skin folds), candidiasis and erythrasma(bacterial infection): the duration of treatment required is usually between 2 and 4 weeks.

Consult your doctor if the disorder recurs or if you have noticed any recent change
in its characteristics.

If you use more TROSYD than you should
No cases of overdose have been reported.
In case of ingestion/accidental intake of TROSYD, immediately inform your doctor or go to the nearest
hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people)
Mild and transient local skin irritation.
If allergic reactions (hypersensitivity) occur, it is necessary to stop treatment and establish appropriate therapy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects 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 which is 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 in waste water 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 have the information about the medicine available, therefore keep both the box and the

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What TROSYD contains
TROSYD 1% Cream
1 g of cream contains:

Active ingredient: Tioconazole: 10 mg

Other ingredients: Polysorbate 60, Sorbitan monostearate, Cetostearyl alcohol, 2 Octyldodecanol, Cetyl esters wax
cetyl alcohol, Benzyl alcohol, Purified water.
TROSYD 1% Cutaneous powder
100 g of powder contain:

Active ingredient: Tioconazole: 1g

Other ingredients: Talc, Magnesium myristate, Kaolin, Precipitated silica.
TROSYD 1% Cutaneous emulsion
100 g of emulsion contain:

Active ingredient: Tioconazole: 1g

Other ingredients: Emulsifying wax, Cetyl alcohol, Cetylstearyl alcohol, Coconut oil, Glyceryl stearate and
palmitate, Propylene glycol, Benzyl alcohol, Purified water.

Description of the appearance of TROSYD and contents of the pack
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 Authorisation Holder
Giuliani S.p.A
Via Palagi, 2 - 20129, Milan

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

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

TROSYD 1% CUTANEOUS SOLUTION

Tioconazole

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What TROSYD is and what it is used for
• 2. What you need to know before you use TROSYD
• 3. How to use TROSYD
• 4. Possible side effects
• 5. How to store TROSYD
• 6. Contents of the pack and other information

1. WHAT TROSYD IS AND WHAT IT IS USED FOR

TROSYD contains the active ingredient tioconazole, an antifungal agent used for:

• The treatment of skin infections caused by fungi such as dermatophytes and yeasts, even if associated with superinfections by Gram-positive bacteria sensitive to the medicine
• As an adjunct (helping) to therapy with other specific topical preparations.

The cutaneous solution allows for greater ease of application in more extensive dermatomycoses (skin infections caused by fungi) and performs a medicated cleansing of glabrous or hairy skin.
Furthermore, by allowing the treatment of a large skin surface, it allows the elimination of the pathogenic agent not
only where morphological (alteration) changes of the skin are detectable, but also where the skin is apparently
healthy.
Consult your doctor if you do not notice any improvement or if your symptoms worsen 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 ingredient or to any of the other ingredients of this medicine
listed in section 6.

Warnings and precautions
Consult your doctor or pharmacist before using TROSYD.
The application of topical medicines, especially if prolonged, may cause allergic
(hypersensitivity) reactions.
The cutaneous solution is an adjunct product (which helps) and, as such, should always be used in association with
a topical therapy with a specific product (creams, lotion, powder).

Children
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 drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with milk
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
the risk/benefit ratio in your case with him.

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

3. HOW TO USE TROSYD

Use this medicine following 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 TROSYD once a day, as a liquid cleanser, and rinse with water after a few
minutes.
Use the amount of solution necessary in relation to the skin surface to be treated,
because when in contact with the skin it forms a foamy solution.

Warning: do not exceed the indicated doses without the advice of your doctor.
The use of TROSYD 1% cutaneous solution must be carried out together with concomitant specific topical
antifungal treatment, applied after using the solution.
The duration of treatment required to achieve healing varies depending on the infecting agent and the site of
infection and is usually between 2 and 4 weeks.
At the doctor's discretion, treatment with the solution may be prolonged even after the end 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/intake of TROSYD, immediately inform your doctor or go to the nearest
hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people)
Mild and transient local skin irritation.
If allergic reactions (hypersensitivity) occur, treatment should be discontinued and appropriate therapy should be initiated.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects 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 which is stated on the packaging. The expiry date refers
to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the box and

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What TROSYD contains
Each 10 g sachet of solution contains:

Active ingredient:Tioconazole: 100 mg

Other components:Monoethanolamine lauryl sulfate; Lecithinamide; Polyglycolum; Undecylenoyl phenylalaninate; Lactic acid;
Soothing lipoessential; 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 Authorisation Holder
Giuliani S.p.A.
via Palagi 2 - 20129 Milano

Manufacturer
Haupt Pharma Latina S.r.l
Borgo San Michele S.S. 156 km. 47,600
04010 Latina