FOILLE 30 G Cream

Зміст інструкції

1. Foille ole cream
   1. What is Foille Sole cream and what is it used for
   2. What you need to know before using Foille Sole cream
   3. How to use Foille Sole cream
   4. Possible side effects
   5. How to store Foille Sole cream
   6. Contents of the pack and other information
2. Foille ole cutaneous spray, solution
   1. What is Foille Sole cutaneous spray, solution and what it is used for
   2. What you need to know before using Foille Sole cutaneous spray, solution
   3. How to use Foille Sole cutaneous spray, solution
   4. Possible side effects
   5. How to store Foille Sole spray cutaneo, solution
   6. Contents of the pack and other information

Foille ole cream

benzyl alcohol, benzocaine, chloroxylenol

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 to do.

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

1. What is Foille Sole cream and what is it used for

Foille Sole cream is a medicine for use on the skin, which contains benzocaine (capable of relieving
pain, burning and itching on the skin), benzyl alcohol (with a disinfectant action and capable of calming
pain) and chloroxylenol (with a disinfectant action).
Foille Sole cream is used:
in case of skin redness due to excessive and prolonged exposure to the sun (sunburns), minor burns, skin irritations from various chemical-physical agents, insect bites;
in the treatment of superficial lesions (abrasions and scratches) and superficial skin wounds.
See a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Foille Sole cream

Do not use Foille Sole cream

• if you are allergic to benzyl alcohol, benzocaine, chloroxylenol or any of the other ingredients of this medicine (listed in section 6);

This medicine should not be applied to the eyes.

Warnings and precautions
Consult your doctor or pharmacist before using Foille Sole cream.
Foille Sole cream should only be used on the skin (for external use), on superficial, non-extensive lesions and for a short period of time.
In the following cases, use this medicine only after consulting your doctor:

• if you have deep wounds, numerous insect bites, when a blister forms with fluid or the skin surface is burned (severe burns) or particularly extensive mild burns;
• in children between 6 months and 2 years of age (see “Children”);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Avoid contact with the eyes.
The effectiveness and safety of benzocaine depend on correct dosage, therefore you must use the minimum amount of medicine sufficient to achieve pain relief.
Apply Foille Sole cream with caution if you have severely damaged mucous membranes or in the presence of redness (inflammation), in order to avoid excessive absorption of benzocaine into the body.
Avoid prolonged use of Foille Sole cream, especially on large areas. The use, especially if prolonged, of medicines on the skin (topical products) can cause irritation or allergic reactions (sensitization). In such cases, stop treatment and consult your doctor in order to receive appropriate therapy.
If the lesion does not improve after a few days, if redness, pain or swelling worsen or if infection occurs, stop using the medicine and consult your doctor immediately.
Also consult your doctor in cases where these disorders have occurred in the past.

Children
Foille Sole cream should not be used in children under 6 months of age.
In children between 6 months and 2 years of age, use this medicine only after consulting your doctor (see “Warnings and precautions”).

Other medicines and Foille Sole cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No disturbances (interactions) are known regarding the association between Foille Sole cream and other medicines.

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.
During pregnancy and breastfeeding, use Foille Sole cream only after consulting your doctor.

Driving and using machines
Foille Sole cream has no effect on the ability to drive and operate machines.

Foille Sole cream contains cetyl alcohol
It may cause localized skin reactions (e.g. contact dermatitis).

Foille Sole cream contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (parabens)
They may cause allergic reactions (even delayed).

Foille Sole cream contains butylated hydroxyanisole (E320)
It may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

Foille Sole creamcontains eugenol (allergen)
It may cause allergic reactions.

3. How to use Foille Sole cream

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 in both adults and children is up to a maximum of 4 applications per
day.

Warning:do not exceed the indicated doses.

Method of use
Apply a light and uniform layer of cream directly to the lesion. In case of small lesions,
after applying the cream, cover the lesion with sterile gauze.
If you use sterile gauze, do not remove the dressing before 48 hours, so as not to interfere
with healing. It is possible not to remove the sterile gauze even for a few days: in this case
keep the dressing moist by applying Foille Sole cream directly to the sterile gauze.
In case of more extensive lesions, it is preferable to use Foille Sole cutaneous spray, solution.
If you do not observe an improvement after a short period of treatment, consult your doctor.
Also consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics (see “Warnings and precautions”).

If you use more Foille Sole cream than you should
In case of ingestion/accidental intake of an excessive dose of Foille Sole cream, immediately notify
your doctor or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and the elderly, can
rarely cause a bluish discoloration of the skin and mucous membranes (cyanosis); in these cases, go to the nearest hospital (see “Possible side effects”).
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.
The use of Foille Sole, especially if prolonged, may give rise to allergic reactions
(sensitization), with the appearance of redness and itching. In this case, discontinue treatment and consult
your doctor to receive appropriate therapy.
Rarely, high absorption of benzocaine may cause, particularly in children and the elderly, a bluish
discoloration (cyanosis) particularly evident on the lips and fingers. In this case, go to the nearest
hospital.

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 provide more information on the safety of this
medicine.

5. How to store Foille Sole cream

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.
Store 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 Foille Sole cream contains

• The active ingredients are: benzyl alcohol, benzocaine and chloroxylenol. 100 g of cream contains 4 g of benzyl alcohol, 5 g of benzocaine and 0.4 g of chloroxylenol.
• The other components are: stearic acid, cetyl alcohol, glycerin, petrolatum oil, isopropyl myristate palmitate and stearate, polysorbate 60, cocoa butter, triethanolamine, carbomer 974P, sorbitan tristearate, methyl parahydroxybenzoate, eugenol, propyl parahydroxybenzoate, butylated hydroxyanisole, purified water.

Description of the appearance of Foille Sole cream and pack contents
Tube containing 30 g.

Marketing Authorisation Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (Netherlands)

Manufacturer
Sanofi Winthrop Industrie – F-45200 Amilly (France)

Distributor
Vemedia Pharma S.r.l – Parma

Foille ole cutaneous spray, solution

benzyl alcohol, benzocaine, chloroxylenol

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 to do.

• 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 Foille Sole cutaneous spray, solution is and what it is used for
• 2. What you need to know before using Foille Sole cutaneous spray, solution
• 3. How to use Foille Sole cutaneous spray, solution
• 4. Possible side effects
• 5. How to store Foille Sole cutaneous spray, solution
• 6. Contents of the pack and other information

1. What is Foille Sole cutaneous spray, solution and what it is used for

Foille Sole cutaneous spray, solution is a medicine for use on the skin, which contains benzocaine
(capable of relieving pain, burning and itching on the skin), benzyl alcohol (with a disinfectant action and
capable of calming pain) and chloroxylenol (with a disinfectant action).
Foille Sole cutaneous spray, solution is used:
in case of skin redness due to excessive and prolonged exposure to the sun (sunburns), minor burns, skin irritations from various chemical-physical agents, insect bites;
in the treatment of superficial lesions (abrasions and scratches) and superficial skin wounds.
See a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Foille Sole cutaneous spray, solution

Do not use Foille Sole cutaneous spray, solution

• if you are allergic to benzyl alcohol, benzocaine, chloroxylenol or any of the other ingredients of this medicine (listed in section 6).

This medicine must not be applied to the eyes.

Warnings and precautions
Consult your doctor or pharmacist before using Foille Sole cutaneous spray, solution.
Foille Sole cutaneous spray, solution must only be used on the skin (for external use), on
superficial, non-extensive lesions and for a short period of time.
In the following cases, use this medicine only after consulting your doctor:

• if you have deep wounds, numerous insect bites, when a blister forms with fluid or the skin surface is burned (severe burns) or particularly extensive mild burns;
• in children between 6 months and 2 years of age (see “Children”);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Avoid contact with the eyes.
Do not spray onto a flame or incandescent bodies. Do not inhale: continuous inhalation of Foille
Sole cutaneous spray, solution may cause dizziness and a feeling of unwellness.
The effectiveness and safety of benzocaine depend on correct dosage, therefore you must
use the minimum amount of medicine sufficient to achieve pain relief.
Apply Foille Sole cutaneous spray, solution with caution if you have severely damaged mucous membranes
or in the presence of redness (inflammation), in order to avoid excessive absorption of benzocaine into the
body.
Avoid prolonged use of Foille Sole cutaneous spray, solution, especially on large areas.
The use, especially if prolonged, of medicines on the skin (topical products) can cause
irritation or allergic reactions (sensitization). In such cases, stop treatment and
consult your doctor to receive appropriate therapy.
If the lesion does not improve after a few days, if redness, pain or swelling worsen or
if infection occurs, stop using the medicine and consult your doctor immediately.
Consult your doctor also in cases where these symptoms have occurred in the past.

Children
Foille Sole cutaneous spray, solution must not be used in children under 6 months of age.
In children between 6 months and 2 years of age, use this medicine only after consulting your doctor
(see “Warnings and precautions”).

Other medicines and Foille Sole cutaneous spray, solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No disturbances (interactions) are known regarding the association between Foille Sole cutaneous spray, solution and
other medicines.

Pregnancy and breastfeeding
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.
During pregnancy and breastfeeding, use Foille Sole cutaneous spray, solution only after
consulting your doctor.

Driving and using machines
Foille Sole cutaneous spray, solution has no effect on the ability to drive vehicles and operate
machinery.

Foille Solecutaneous spray, solution contains propylene glycol
This medicine contains 700 mg of propylene glycol in each pack (70 g) equivalent to 10 mg/g.

Foille Solecutaneous spray, solution contains ethyl alcohol
This medicine contains 58.19 g of alcohol (ethanol) in each pack (70 g) which is equivalent to 831.29
mg/g (83.1% w/w).
It may cause a burning sensation on damaged skin.

3. How to use Foille Sole cutaneous spray, solution

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in both adults and children is up to a maximum of 4 applications per day.

Warning:do not exceed the indicated doses.

Mode of use
Follow these instructions carefully for application:
1 shake the bottle and then remove the cap;
2 direct the hole of the dispensing valve towards the area to be treated, keeping it about a palm’s width away;
3 press the dispensing valve, in order to obtain a light and uniform layer.
If you do not observe an improvement after a short period of treatment, consult your doctor.
Also, consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics (see “Warnings and precautions”).

If you use more Foille Sole cutaneous spray, solution than you should
In case of ingestion/accidental intake of an excessive dose of Foille Sole cutaneous spray, solution, immediately notify your doctor or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and the elderly, can rarely cause a bluish discoloration of the skin and mucous membranes (cyanosis); in these cases, go to the nearest hospital (see “Possible side effects”).
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.
The use of Foille Sole spray cutaneo, solution, especially if prolonged, may give rise to allergic
reactions (sensitization), with the appearance of redness and itching. If this occurs, stop the
treatment and consult your doctor to receive appropriate therapy.
Rarely, high absorption of benzocaine can cause, particularly in children and the elderly, a bluish
discoloration (cyanosis) particularly evident on the lips and fingers. In this case, go to the nearest
hospital.

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 Foille Sole spray cutaneo, solution

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.
Store at a temperature below 25°C. Keep the container in the outer packaging to
protect the medicine from light.
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 Foille Sole cutaneous spray, solution contains

• The active ingredients are: benzyl alcohol, benzocaine and chloroxylenol. 100 g of spray contain 4 g of benzyl alcohol, 5 g of benzocaine and 0.6 g of chloroxylenol
• The other ingredients are: ethanol96%, PPG20 methyl glucose ether, ammonium spirit, glycerol, propyleneglycol.

Description of the appearance of Foille Sole cutaneous spray, solution and contents of the pack
Container of 70 g.

Marketing Authorisation Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (Netherlands)

Manufacturer
Farmol Health Care S.r.l.– Via Del Maglio, 6 – IT-23868 Valmadrera (LC)

Sales representative
Vemedia Pharma S.r.l – Parma