Fitostimoline

Package leaflet: Information for the user

FITOSTIMOLINE 600 mg suppositories

aqueous extract of Triticum vulgare
Please read all of this leaflet carefully before you use 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 instructed you.

• 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 you experience worsening of symptoms.

Contents of this leaflet:

1. What FITOSTIMOLINE 600 mg suppositories are and what they are used for
2. What you need to know before using FITOSTIMOLINE 600 mg suppositories
3. How to use FITOSTIMOLINE 600 mg suppositories
4. Possible side effects
5. How to store FITOSTIMOLINE 600 mg suppositories
6. Contents of the pack and other information

1. What FITOSTIMOLINE 600 mg suppositories is and what it is used for

FITOSTIMOLINE 600 mg suppositories contains an aqueous extract of Triticum vulgare and is indicated in adults for the treatment of inflammatory (with inflammatory component) and dystrophic (with minor lesions) diseases of any nature affecting the female genital tract.
Consult a doctor if you do not feel better or feel worse after treatment.

2. What you should know before using FITOSTIMOLINE 600 mg suppositories

Do not use FITOSTIMOLINE 600 mg suppositories
If you are allergic to the active substance (aqueous extract of Triticum vulgare) or to any of the other
components of this medicine (listed in section 6).
Do not use FITOSTIMOLINE 600 mg suppositories in children or adolescents (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using FITOSTIMOLINE 600 mg suppositories.
Immediately stop treatment if sensitization reactions (excessive reactivity towards the product) occur.
The use, especially if prolonged, of any topical (local) products may lead to such reactions.
Discontinue treatment also in case of emergence of insensitive germs (microorganisms not responding to the treatment with the medicine).

Children and adolescents
Do not use FITOSTIMOLINE 600 mg suppositories in children or adolescents (see "Do not use
FITOSTIMOLINE 600 mg suppositories").

Other medicines and FITOSTIMOLINE 600 mg suppositories
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between FITOSTIMOLINE 600 mg suppositories and other drugs are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use FITOSTIMOLINE 600 mg suppositories during pregnancy or while breastfeeding.

Driving and using machines
FITOSTIMOLINE 600 mg suppositories do not affect the ability to drive vehicles or operate machinery.

3. How to use FITOSTIMOLINE 600 mg vaginal tablets

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.
The recommended dose is 1 tablet at bedtime, or as directed by the physician.
Method of administration:
Insert the tablet deeply into the vagina.
If you use more FITOSTIMOLINE 600 mg vaginal tablets than you should
Cases of overdose have not been reported.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
No side effects have been reported.
The use, especially if prolonged, of any topical products may lead to sensitization phenomena.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FITOSTIMOLINE 600 mg suppositories

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 and to the product in its original, undamaged packaging, properly stored.
Do not store above 25°C.
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.

6. Package contents and other information

What FITOSTIMOLINE 600 mg suppositories contains
One 3.5 g suppository contains:
Active substance: aqueous extract of Triticum vulgare (dry residue equal to 200 mg/100 ml) 600 mg.
Other components: 2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 12000.

Description of the appearance of FITOSTIMOLINE 600 mg suppositories and package contents
Homogeneous white suppositories.
Packaging: 6 suppositories of 3.5 g.

Marketing Authorization Holder and Manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Naples.

Package leaflet: information for the user

FITOSTIMOLINE 20% vaginal cream

aqueous extract of Triticum vulgare
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 your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What FITOSTIMOLINE 20% vaginal cream is and what it is used for
2. What you need to know before using FITOSTIMOLINE 20% vaginal cream
3. How to use FITOSTIMOLINE 20% vaginal cream
4. Possible side effects
5. How to store FITOSTIMOLINE 20% vaginal cream
6. Contents of the pack and other information

1. What FITOSTIMOLINE 20% vaginal cream is and what it is used for

FITOSTIMOLINE 20% vaginal cream contains an aqueous extract of Triticum vulgare and is indicated in
adults for the treatment of inflammatory (with inflammatory component) and dystrophic (with minor lesions)
conditions of any nature affecting the female genital tract.
Consult your doctor if you do not feel better or if you feel worse after treatment.

2. What you need to know before using FITOSTIMOLINE 20% vaginal cream

Do not use FITOSTIMOLINE 20% vaginal cream
If you are allergic to the active substance (aqueous extract of Triticum vulgare) or to any of the other
components of this medicinal product (listed in section 6).
Do not use FITOSTIMOLINE 20% vaginal cream in children or adolescents (see "Children and
adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using FITOSTIMOLINE 20% vaginal cream.
Immediately discontinue treatment if sensitization reactions occur (excessive reactivity to the
product). The use, especially if prolonged, of any topical (local) products may lead to such
reactions.
Stop treatment also in case of development of insensitive germs (microorganisms unresponsive to the drug treatment).

Children and adolescents
Do not use FITOSTIMOLINE 20% vaginal cream in children or adolescents (see "Do not use
FITOSTIMOLINE 20% vaginal cream").

Other medicines and FITOSTIMOLINE 20% vaginal cream
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interactions between FITOSTIMOLINE 20% vaginal cream and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before using this medicinal product.
You may use FITOSTIMOLINE 20% vaginal cream during pregnancy or while breastfeeding.

Driving and using machines
FITOSTIMOLINE 20% vaginal cream does not affect the ability to drive or operate machinery.

FITOSTIMOLINE 20% vaginal cream contains cetyl stearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis).
FITOSTIMOLINE 20% vaginal cream contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use FITOSTIMOLINE 20% vaginal cream

Use this medicinal product exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 vaginal applications per day, or as directed by the physician.
Instructions for use:

1. Pierce the cream tube for the first time using the perforator located in the top part of the closure cap.
2. Screw on a vaginal applicator.
3. Squeeze the cream tube until the applicator is completely filled.
4. Unscrew the applicator from the tube, insert it into the vagina and press the plunger fully to its end position.
5. Use each applicator only once.
   If you use more FITOSTIMOLINE 20% vaginal cream than you should
   Cases of overdose have not been reported.
   If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No side effects have been reported.
The use, especially if prolonged, of any topical products may lead to sensitization phenomena.
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FITOSTIMOLINE 20% vaginal cream

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging, correctly stored.
This medicinal product does not require any special storage conditions.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FITOSTIMOLINE 20% vaginal cream contains
Each 100 g of cream contains:
Active substance: aqueous extract of Triticum vulgare (dry residue equivalent to 200 mg/100 ml) 20 g.
Other components: 2-phenoxyethanol; glycerin; white soft paraffin; sodium cetostearyl sulfate; cetyl stearyl alcohol; decyl oleate; methyl 4-hydroxybenzoate; propyl 4-hydroxybenzoate; purified water.

Description of the appearance of FITOSTIMOLINE 20% vaginal cream and package contents
Homogeneous white vaginal cream.
Tube containing 60 g of cream with 12 single-use vaginal applicators.

Marketing Authorization Holder and Manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Naples.

Patient Information Leaflet: Information for the user

FITOSTIMOLINE 4% vaginal solution

aqueous extract of Triticum vulgare
Please read this entire 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 instructed you.

• 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.

Contents of this leaflet:

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

1. What FITOSTIMOLINE 4% vaginal solution is and what it is used for

FITOSTIMOLINE 4% vaginal solution contains an aqueous extract of Triticum vulgare and is indicated in
adults for the treatment of inflammatory (with inflammatory component) and dystrophic (with minor lesions) diseases of any nature affecting the female genital tract.
FITOSTIMOLINE 4% vaginal solution is also indicated for pre- and post-operative prevention in connection with gynecological surgical procedures.
Consult your doctor if you do not feel better or if you feel worse after treatment.

2. What you need to know before using FITOSTIMOLINE 4% vaginal solution

Do not use FITOSTIMOLINE 4% vaginal solution
If you are allergic to the active substance (aqueous extract of Triticum vulgare) or to any of the other
components of this medicine (listed in section 6).
Do not use FITOSTIMOLINE 4% vaginal solution in children or adolescents (see "Children and
adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using FITOSTIMOLINE 4% vaginal solution.
Stop treatment immediately if sensitization symptoms occur (excessive reactivity to the product). The use, especially prolonged, of any topical (local) products may lead to such reactions.
Discontinue treatment also in case of development of insensitive germs (germs that do not respond to treatment with the medicine).

Children and adolescents
Do not use FITOSTIMOLINE 4% vaginal solution in children or adolescents (see "Do not use FITOSTIMOLINE 4% vaginal solution").

Other medicines and FITOSTIMOLINE 4% vaginal solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between FITOSTIMOLINE 4% vaginal solution and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use FITOSTIMOLINE 4% vaginal solution during pregnancy or while breastfeeding.

Driving and using machines
FITOSTIMOLINE 4% vaginal solution does not affect the ability to drive or operate machinery.

FITOSTIMOLINE 4% vaginal solution contains benzalkonium chloride, which may cause local irritation.

3. How to use FITOSTIMOLINE 4% vaginal solution

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.
The recommended dose is 1-2 vaginal applications per day, or as directed by your physician.
Instructions for use:

1. Hold the bottle by the closure ring and bend the cap until the safety seal breaks.
2. Pull out the cannula until it stops, making sure you hear the click indicating correct positioning.
   Warning: Only correct extraction of the cannula ensures complete release of the liquid.
3. Gently insert the cannula into the vagina, directing it at the desired angle.
4. Slowly press the sides of the bottle to completely empty its contents.
   It is preferable to perform the application while lying down, retaining the liquid in the vagina for a few minutes.
   If you use more FITOSTIMOLINE 4% vaginal solution than you should
   Cases of overdose have not been reported.
   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 may cause adverse reactions, although not everybody will experience them.
No adverse reactions have been reported.
The use, especially if prolonged, of any topical products may lead to sensitization phenomena.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store FITOSTIMOLINE 4% vaginal solution

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 and applies to the product in its original, unopened packaging, stored correctly.
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 you no longer use. This will help protect the environment.

6. Pack contents and other information

What FITOSTIMOLINE 4% vaginal solution contains
100 ml of solution contain:
Active substance: 4 g aqueous extract of Triticum vulgare (corresponding to a dry residue of 200 mg/100 ml).
Other components: 2-phenoxyethanol; benzalkonium chloride; purified water.

Description of the appearance of FITOSTIMOLINE 4% vaginal solution and pack contents
Vaginal solution. Clear, slightly yellowish liquid.
5 plastic bottles of 140 ml, each equipped with a pre-inserted vaginal cannula.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
FARMACEUTICI DAMOR S.p.A., Via E. Scaglione, 27 - 80145 Naples, Italy.

Manufacturer
FARMACEUTICI DAMOR S.p.A., Via E. Scaglione, 27 - 80145 Naples, Italy.
COC FARMACEUTICI S.r.l., Via Modena 15 – 40019 Sant’Agata Bolognese (BO), Italy.

Package leaflet: Information for the user

FITOSTIMOLINE 15% cream

Aqueous extract of Triticum vulgare
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.

Contents of this leaflet:

1. What FITOSTIMOLINE 15% cream is and what it is used for
2. What you need to know before using FITOSTIMOLINE 15% cream
3. How to use FITOSTIMOLINE 15% cream
4. Possible side effects
5. How to store FITOSTIMOLINE 15% cream
6. Contents of the pack and other information

1. WHAT FITOSTIMOLINE 15% CREAM IS AND WHAT IT IS USED FOR

FITOSTIMOLINE 15% cream contains an aqueous extract of Triticum vulgare and has a healing action.
This medicinal product is indicated for the treatment of superficial skin erosions and mild pressure ulcers (skin lesions that develop on body parts subjected to prolonged pressure during extended bed rest or sitting).

2. WHAT YOU NEED TO KNOW BEFORE USING FITOSTIMOLINE 15% CREAM

Do not use FITOSTIMOLINE 15% cream
If you are allergic to the active ingredient, aqueous extract of Triticum vulgare, or to any of the other
components of this medicinal product (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using FITOSTIMOLINE 15% cream.
Immediately discontinue treatment if sensitization reactions occur (excessive reactivity to the product).
The use, especially if prolonged, of any topical (local) products may lead to such reactions.
Stop treatment also if infections develop.

Other medicines and FITOSTIMOLINE 15% cream
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between FITOSTIMOLINE 15% cream and other drugs are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
FITOSTIMOLINE 15% cream may be used during pregnancy or breastfeeding, but only under medical supervision.

Driving and operating machinery
FITOSTIMOLINE 15% cream does not affect the ability to drive vehicles or operate machinery.

FITOSTIMOLINE 15% cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

3. HOW TO USE FITOSTIMOLINE 15% cream

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.
The recommended dose is 2 applications per day. Depending on the severity, extent and location of the lesions, these applications may consist of simple massage for absorption, or it may be necessary to cover the affected area as described in the application instructions below.

Instructions for use
To open the tube for the first time, pierce the protective membrane of the tube using the perforator located on the top of the closure cap.
Apply an adequate amount of cream to the affected area and cover the site with a sterile gauze dressing, optionally impregnated with the same cream, in order to maintain softness and plasticity of the application.
During subsequent dressing changes, unless otherwise contraindicated, it is sufficient to wash the affected skin area with sterile water alone, as the cream is completely hydrodispersible (dissolves in water) and leaves no residue.

If you use more FITOSTIMOLINE 15% cream than you should
Cases of overdose have not been reported.
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 everyone experiences them.
No adverse reactions have been reported so far.
Following the instructions 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FITOSTIMOLINE 15% cream

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 and to the product in its original, undamaged packaging, properly stored.
Store the product at a temperature below 30 °C.
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.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What FITOSTIMOLINE 15% cream contains
100 g of cream contain:
Active substance: aqueous extract of Triticum vulgare 15 g (dry residue equal to 200 mg/100 ml).
Other components: 2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 3000; macrogol 4000; liquid paraffin; cetyl alcohol; stearyl alcohol; glycerin; purified water.

Description of the appearance of FITOSTIMOLINE 15% cream and contents of the package
Cream.
Aluminum tube containing 32 g of cream.

Marketing Authorization Holder and Manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Naples.

Package leaflet: Information for the user

FITOSTIMOLINE 15% impregnated gauzes

Aqueous extract of Triticum vulgare
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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

1. What FITOSTIMOLINE 15% impregnated gauzes is and what it is used for
2. What you need to know before using FITOSTIMOLINE 15% impregnated gauzes
3. How to use FITOSTIMOLINE 15% impregnated gauzes
4. Possible side effects
5. How to store FITOSTIMOLINE 15% impregnated gauzes
6. Contents of the pack and other information

1. WHAT FITOSTIMOLINE 15% IMPREGNATED Gauzes IS AND WHAT IT IS USED FOR

FITOSTIMOLINE 15% impregnated gauzes contains an aqueous extract of Triticum vulgare and has a
healing action.
This medicinal product is indicated for the treatment of superficial skin erosions and mild pressure ulcers (skin lesions occurring in body areas subjected to prolonged pressure during extended bed rest or sitting).

2. WHAT YOU SHOULD KNOW BEFORE USING FITOSTIMOLINE 15% IMPREGNATED Gauzes

Do not use FITOSTIMOLINE 15% IMPREGNATED Gauzes
If you are allergic to the active substance, aqueous extract of Triticum vulgare, or to any of the other
components of this medicinal product (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using FITOSTIMOLINE 15% IMPREGNATED Gauzes.
Immediately discontinue treatment if sensitization reactions (excessive reactivity to the product) occur.
The use, especially if prolonged, of any topical (local) products may lead to such reactions.
Stop treatment also if infections develop.

Other medicines and FITOSTIMOLINE 15% IMPREGNATED Gauzes
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between FITOSTIMOLINE 15% IMPREGNATED Gauzes and other drugs are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
FITOSTIMOLINE 15% IMPREGNATED Gauzes may be used during pregnancy or breastfeeding, but only under medical supervision.

Driving and using machines
FITOSTIMOLINE 15% IMPREGNATED Gauzes does not affect the ability to drive or operate machinery.

3. HOW TO USE FITOSTIMOLINE 15% impregnated gauzes

Use this medicinal product exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 applications per day.
Ensure that the dressing remains constantly moist, soft, and pliable (deformable).
Open a sachet, remove the protective plastic film, take out the gauze and apply it directly to the area previously cleansed and disinfected.
Cover the area with a sterile gauze and, if necessary, with hydrophilic cotton.
For subsequent dressing changes, unless specific contraindications exist, it will be sufficient to wash the affected area with a sterile solution, as the cream is completely hydrodispersible (dissolves in water) and leaves no residue.

If you use more FITOSTIMOLINE 15% impregnated gauzes than you should
Cases of overdose have not been reported.
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 may cause adverse reactions, although not everyone experiences them.
No adverse reactions have been reported to date.
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 the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE FITOSTIMOLINE 15% impregnated gauzes

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 and to the product kept in its original, undamaged packaging, properly stored.
Store the product at a temperature below 30 °C.
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.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What FITOSTIMOLINE 15% impregnated gauzes contain
Each gauze is impregnated with 4 g of cream having the following composition (per 100 grams):
Active substance: aqueous extract of Triticum vulgare 15 g (dry residue equal to 200 mg/100 ml).
In 4 g of cream (content of each gauze) there are 0.6 g of aqueous extract of Triticum vulgare.
Other components: 2-phenoxyethanol; macrogol 400; macrogol 600; macrogol 1500; macrogol 4000; glycerin;
purified water.

Description of the appearance of FITOSTIMOLINE 15% impregnated gauzes and packaging contents
10 impregnated gauzes 10 cm x 10 cm, each impregnated with 4 grams of white, fluid, hydrodispersible cream, individually packaged in single sachets.

Marketing Authorization Holder and Manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Naples.