FITOSTIMOLINE 15% Cream

Зміст інструкції

1. FITOSTIMOLINE 600 mg suppositories
   1. What is FITOSTIMOLINE 600 mg suppositories and what is it 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
2. FITOSTIMOLINE 20 % vaginal cream
   1. What is FITOSTIMOLINE 20 % vaginal cream and what is it 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
3. FITOSTIMOLINE 4 % vaginal solution
   1. What is FITOSTIMOLINE 4 % vaginal solution and what is it 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. Package contents and other information
4. FITOSTIMOLINE 15% cream
   1. WHAT FITOSTIMOLINE 15% cream IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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
5. FITOSTIMOLINE 15% impregnated gauzes
   1. WHAT FITOSTIMOLINE 15% impregnated gauzes ARE AND WHAT THEY ARE USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE FITOSTIMOLINE 15% impregnated gauzes
   3. HOW TO USE FITOSTIMOLINE 15% impregnated gauze
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FITOSTIMOLINE 15% impregnated gauze
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

FITOSTIMOLINE 600 mg suppositories

aqueous extract of Triticum vulgare

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.

Contents of this leaflet:

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

FITOSTIMOLINE 600 mg suppositories contains aqueous extract of Triticum vulgareand is indicated in adult subjects for the treatment of inflammatory (with an inflammatory component) and dystrophic (with small lesions) diseases of any nature of 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 600 mg suppositories

Do not use FITOSTIMOLINE 600 mg suppositories
If you are allergic to the active ingredient (aqueous extract of Triticum vulgare) or to any of the other ingredients 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
Consult your doctor or pharmacist before using FITOSTIMOLINE 600 mg suppositories.
Immediately discontinue treatment if sensitization phenomena (excessive reactivity to the product) occur. The use, especially if prolonged, of all topical (local) products can give rise to these types of phenomena.
Also discontinue treatment in case of development of germs that are insensitive (that do not respond to treatment with the drug).

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, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
You can use FITOSTIMOLINE 600 mg suppositories if you are pregnant or breastfeeding.

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

3. How to use FITOSTIMOLINE 600 mg suppositories

Use this medicine following the instructions provided 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 suppository in the evening or as advised by your doctor.
Method of administration:
Insert the suppository deeply into the vagina.

If you use more FITOSTIMOLINE 600 mg suppositories than you should
No cases of overdose have been reported.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported.
The use, especially if prolonged, of all topical products may give rise to sensitisation phenomena.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help to 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 which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
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.

6. Contents of the pack and other information

What FITOSTIMOLINE 600 mg suppositories contain
One 3.5 g suppository contains:

Active ingredient: aqueous extract of Triticum vulgare(dry residue equivalent to 200 mg/100 ml) 600 mg.

Other ingredients: 2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 12000.

Description of the appearance of FITOSTIMOLINE 600 mg suppositories and contents of the pack
Homogeneous white suppositories.
Pack of 6 suppositories of 3.5 g.

Marketing authorisation holder and manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Napoli.

FITOSTIMOLINE 20 % vaginal cream

aqueous extract of Triticum vulgare

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.

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 is FITOSTIMOLINE 20 % vaginal cream and what is it used for

FITOSTIMOLINE 20 % vaginal cream contains aqueous extract of Triticum vulgare and is indicated in
adults for the treatment of inflammatory (with an inflammatory component) and dystrophic (with
small lesions) diseases of any nature of the female genital tract.
See a 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 ingredient (aqueous extract of Triticum vulgare) or to any of the other
ingredients of this medicine (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.
Stop treatment immediately if you experience sensitization phenomena (excessive reactivity to the
product). The use, especially if prolonged, of all topical (local) products can give rise to
these types of phenomena.
Also discontinue treatment in case of development of germs insensitive (that do not respond to treatment with
the drug).

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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No interactions between FITOSTIMOLINE 20 % vaginal cream and 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.
You can use FITOSTIMOLINE 20 % vaginal cream if you are pregnant or breastfeeding.

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

FITOSTIMOLINE 20 % vaginal cream contains cetyl stearyl alcoholwhich may cause local skin
reactions (e.g. contact dermatitis).

FITOSTIMOLINE 20 % vaginal cream contains methyl parahydroxybenzoate and propyl
parahydroxybenzoatewhich may cause allergic reactions (including delayed reactions).

3. How to use FITOSTIMOLINE 20 % vaginal cream

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.
The recommended dose is 1-2 vaginal applications per day or as directed by your doctor.
Method of application:

• 1) Pierce the tube of cream for the first time, using the perforator contained in the top of the closure cap.
• 2) Screw on a vaginal applicator.
• 3) Press the tube of cream until the applicator is completely filled.
• 4) Unscrew the applicator from the tube, insert it into the vagina and press the plunger until the end of its stroke.
• 5) Use each applicator only once.

If you use more FITOSTIMOLINE 20 % vaginal cream than you should
No cases of overdose have been reported.
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.
No side effects have been reported.
The use, especially if prolonged, of all topical products may give rise to sensitization phenomena.

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 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 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 and to the product in intact packaging, correctly stored.
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.

6. Contents of the pack and other information

What FITOSTIMOLINE 20 % vaginal cream contains
100 g of cream contains:

Active ingredient: aqueous extract of Triticum vulgare(dry residue equivalent to 200 mg/100 ml) 20 g.

Other components: 2-phenoxyethanol; glycerin; white petrolatum; sodium cetyl stearyl sulfate; cetyl stearyl alcohol; decyl oleate; methyl parahydroxybenzoate; propyl parahydroxybenzoate; purified water.

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

Marketing authorisation holder and manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Napoli.

FITOSTIMOLINE 4 % vaginal solution

aqueous extract of Triticum vulgare

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.

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 is FITOSTIMOLINE 4 % vaginal solution and what is it used for

FITOSTIMOLINE 4 % vaginal solution contains aqueous extract of Triticum vulgareand is indicated in
adults for the treatment of inflammatory (with an inflammatory component) and dystrophic (with
small lesions) diseases of any nature of the female genital tract.
FITOSTIMOLINE 4 % vaginal solution is also indicated in pre- and post-operative prevention in case
of gynecological surgical interventions.
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 ingredient (aqueous extract of Triticum vulgare) or to any of the other
ingredients 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 you experience sensitization phenomena (excessive reactivity to the
product). The use, especially if prolonged, of all topical (local) products can give rise to these types of
phenomena.
Also discontinue treatment in case of development of germs insensitive (that do not respond to treatment with
the drug).

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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No interactions between FITOSTIMOLINE 4 % vaginal solution and 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,
ask your doctor or pharmacist for advice before using this medicine.
You can use FITOSTIMOLINE 4 % vaginal solution if you are pregnant or breastfeeding.

Driving and operating machinery
FITOSTIMOLINE 4 % vaginal solution does not impair the ability to drive or operate machinery.

FITOSTIMOLINE 4 % vaginal solution contains benzalkonium chloridewhich may cause
local re-irritation.

3. How to use FITOSTIMOLINE 4 % vaginal solution

Use this medicine following exactly as described in this leaflet or as instructed 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 doctor.
Method of application:

• 1) Hold the bottle by the closing ring and bend the cap until the safety seal is broken.
• 2) Extract the applicator until it stops, so you can feel it click into the correct position. Caution: only correct extraction of the applicator allows complete release of the liquid.
• 3) Gently insert the applicator into the vagina, orienting it at the desired angle.
• 4) Slowly press the walls of the bottle to allow complete emptying.

The application should preferably be performed in a lying position, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No adverse effects have been reported.
The use, especially if prolonged, of all topical products may give rise to sensitisation phenomena.

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 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 4 % vaginal solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to
the last day of that month and to the product in intact packaging, correctly stored.
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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What FITOSTIMOLINE 4 % vaginal solution contains
100 ml of solution contains:

Active ingredient: aqueous extract of Triticum vulgare4 g (dry residue equivalent to 200 mg/100 ml).

Other components: 2-phenoxyethanol; benzalkonium chloride; purified water.

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

Marketing authorisation holder and manufacturer
Marketing authorisation holder
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Napoli.

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

FITOSTIMOLINE 15% cream

Aqueous extract of Triticum vulgare

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.

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 cicatrizing action.
This medicine is indicated for the treatment of superficial skin erosions and of mild pressure ulcers
(skin lesions that occur in parts of the body subjected to pressure for a long time during a
prolonged stay in bed or in a seated position).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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
ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using FITOSTIMOLINE 15% cream.
Immediately discontinue treatment if sensitization phenomena occur (excessive reactivity to the
product). The use, especially if prolonged, of all topical (local) products can give rise to phenomena
of this type.
Also discontinue treatment if infections develop.

Other medicines and FITOSTIMOLINE 15% cream
Tell 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 are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
FITOSTIMOLINE 15% cream can be used during pregnancy or breastfeeding, always under
medical supervision.

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

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

3. HOW TO USE FITOSTIMOLINE 15% cream

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 applications per day. These applications, depending on the extent, size and
location of the manifestations, may consist of simple absorption massages, or
it may be necessary to cover the affected part according to the suggested application methods.
Method of application
To open the tube for the first time, puncture the protective membrane of the tube using the perforator contained
in the upper part of the cap.
Spread an adequate amount of cream on the affected area and cover the area with sterile gauze,
possibly impregnated with the same cream in order to maintain the softness and plasticity
of its application.
In subsequent dressings, unless specific contraindications, it will be sufficient to perform a washing of the
affected skin area with simple sterile water, as the cream is completely water-dispersible (dissolves in water) and does not leave residues.

If you use more FITOSTIMOLINE 15% cream than you should
No cases of overdose have been reported.
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.
No adverse effects have been reported at this time.

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
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 15% cream

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 and to the product in intact packaging, correctly stored.
Store the product at a temperature below 30 °C.
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What FITOSTIMOLINE 15% cream contains
100 g of cream contains:

Active ingredient: aqueous extract of Triticum vulgare15 g (dry residue equivalent to 200 mg/100 ml).

Other components: 2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 3000; macrogol 4000; liquid paraffin;
cetyl alcohol; stearyl alcohol; glycerol; purified water.

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

Marketing authorization holder and manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Napoli.

FITOSTIMOLINE 15% impregnated gauzes

Aqueous extract of Triticum vulgare

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.

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 ARE AND WHAT THEY ARE USED FOR

FITOSTIMOLINE 15% impregnated gauzes contains an aqueous extract of Triticum vulgare and has a
wound-healing action.
This medicine is indicated for the treatment of superficial skin erosions and mild pressure ulcers
(skin lesions that occur in parts of the body subjected to pressure for a long time during a
long stay in bed or in a seated position).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FITOSTIMOLINE 15% impregnated gauzes

Do not use FITOSTIMOLINE 15% impregnated gauzes
If you are allergic to the active ingredient aqueous extract of Triticum vulgare or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using FITOSTIMOLINE 15% impregnated gauzes.
Immediately stop treatment if you experience sensitization phenomena (excessive reactivity to the
product). The use, especially if prolonged, of all topical (local) products can give rise to
these types of phenomena.
Also discontinue treatment if infections develop.

Other medicines and FITOSTIMOLINE 15% impregnated gauzes
Tell 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 are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
FITOSTIMOLINE 15% impregnated gauzes can be used during pregnancy or breastfeeding,
always under medical supervision.

Driving and operating machinery
FITOSTIMOLINE 15% impregnated gauzes does not impair the ability to drive vehicles or operate machinery.

3. HOW TO USE FITOSTIMOLINE 15% impregnated gauze

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.
The recommended dose is 1-2 applications per day.
Ensure that the dressing remains always moist, soft and pliable (deformable).
Open a sachet, remove the protective plastic film, take the gauze and apply it directly to the previously cleansed (cleaned) and disinfected area.
Cover the area with a sterile gauze and, if necessary, with cotton wool.
In subsequent dressings, unless specific contraindications, it will be sufficient to perform a washing of the affected area with sterile solution, as the cream is completely water-dispersible (dissolves in water) and does not leave residues.

If you use more FITOSTIMOLINE 15% impregnated gauze than you should
No cases of overdose have been reported.
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.
No side effects have been reported to date.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 15% impregnated gauze

Keep this medicine out of 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 and the product in intact packaging, correctly stored.
Store the product at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What FITOSTIMOLINE 15% impregnated gauzes contain
Each gauze is impregnated with 4 g of cream with the following composition (per 100 grams):

Active ingredient: aqueous extract of Triticum vulgare15 g (dry residue equivalent 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 contents of the pack
10 Impregnated gauzes 10 cm x 10 cm impregnated with 4 grams of fluid, water-dispersible white cream,
packaged in single sachets.

Marketing authorisation holder and manufacturer
FARMACEUTICI DAMOR S.p.A. Via E. Scaglione, 27 - 80145 Napoli.