Foille Sole
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: information for the patient
Foille Sole cream
benzyl alcohol, benzocaine, chloroxylenol
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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.
Contents of this leaflet:
- What Foille Sole cream is and what it is used for
- What you need to know before using Foille Sole cream
- How to use Foille Sole cream
- Possible side effects
- How to store Foille Sole cream
- Contents of the pack and other information
1. What Foille Sole cream is and what it is used for
Foille Sole cream is a topical medicinal product containing benzocaine (which relieves pain, burning, and itching of the skin), benzyl alcohol (with antiseptic and analgesic properties), and chloroxylenol (with antiseptic action).
Foille Sole cream is used:
in cases of skin redness due to excessive and prolonged sun exposure (sunburns), minor burns, skin irritations caused by various physical-chemical agents, and insect bites;
for the treatment of superficial skin lesions (excoriations and abrasions) and superficial wounds.
Consult your 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 must not be applied to the eyes.
Warnings and precautions
Talk to your doctor or pharmacist before using Foille Sole cream.
Foille Sole cream should be used only on the skin (for topical use), on superficial and limited lesions, and for a short period of time.
Use this medicine only after consulting your doctor in the following cases:
- if you have deep wounds, multiple insect bites, formation of fluid-filled blisters, or if the skin surface is burned (severe burns) or extensively affected by 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 dosing; therefore, use the smallest amount of medicine sufficient to achieve pain relief.
Apply Foille Sole cream with caution if you have severely damaged mucous membranes or if redness (inflammation) is present, to avoid excessive absorption of benzocaine into the body.
Avoid prolonged use of Foille Sole cream, especially over large areas of skin. The use, particularly if prolonged, of medicines on the skin (topical products) may lead to irritation or allergic reactions (sensitization). If this occurs, stop treatment and consult your doctor to receive appropriate therapy.
If the lesion does not improve within a few days, if redness, pain or swelling worsens, or if signs of infection appear, discontinue use of the medicine and consult your doctor immediately.
Consult your doctor also if such symptoms have occurred in the past.
Children
Foille Sole cream 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 cream
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
No interactions with other medicines are known for Foille Sole cream.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
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 vehicles or operate machinery.
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 (including delayed reactions).
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 cream contains eugenol (allergen)
It may cause allergic reactions.
3. How to use Foille Sole cream
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, both in adults and children, is up to a maximum of 4 applications per day.
Warning: Do not exceed the recommended doses.
Instructions for use
Apply a thin, uniform layer of cream directly to the affected area. In the case of small lesions, after applying the cream, cover the lesion with sterile gauze.
If using sterile gauze, do not remove the dressing before 48 hours, so as not to interfere with the healing process. It is possible not to remove the sterile gauze for several days: in this case, keep the dressing moist by applying Foille Sole cream directly onto the sterile gauze.
For larger lesions, Foille Sole cutaneous spray solution is preferred.
If there is no improvement after a short period of treatment, consult your doctor.
Also consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics (see "Warnings and precautions").
If you use more Foille Sole cream than you should
In case of accidental ingestion/overdose of Foille Sole cream, inform your doctor immediately or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and elderly patients, may rarely cause a bluish discoloration of the skin and mucous membranes (cyanosis); in such cases, go immediately to the nearest hospital (see "Possible side effects").
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 can cause side effects, although not everybody gets them.
The use of Foille Sole, especially if prolonged, may lead to allergic reactions (sensitization), resulting in redness and itching. In such cases, stop treatment and consult your doctor to receive appropriate therapy.
Rarely, excessive absorption of benzocaine may cause, particularly in children and elderly patients, a bluish discoloration (cyanosis), most noticeably on the lips and fingers. In this case, go immediately to the nearest hospital.
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 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 Foille Sole 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.
Store 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. Package contents and other information
What Foille Sole cream contains
- The active substances are: benzyl alcohol, benzocaine and chloroxylenol. 100 g of cream contain 4 g of benzyl alcohol, 5 g of benzocaine and 0.4 g of chloroxylenol.
- The other components are: stearic acid, cetyl alcohol, glycerin, vaseline oil, isopropyl myristate palmitate and stearate, polysorbate 60, cocoa butter, triethanolamine, carbomer 974P, sorbitan tristearate, methyl p-hydroxybenzoate, eugenol, propyl p-hydroxybenzoate, butylhydroxyanisole, purified water.
Description of the appearance of Foille Sole cream and package contents
Tube of 30 g.
Marketing Authorization Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (The Netherlands)
Manufacturer
Sanofi Winthrop Industrie – F-45200 Amilly (France)
Sales Licensee
Vemedia Pharma S.r.l – Parma
INSTRUCTIONS FOR USE
Patient Information Leaflet
Foille Ole Spray Cutaneo, Solution
Benzyl alcohol, benzocaine, chloroxylenol
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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What Foille Ole Cutaneous Spray, Solution is and what it is used for
- What you need to know before using Foille Ole Cutaneous Spray, Solution
- How to use Foille Ole Cutaneous Spray, Solution
- Possible side effects
- How to store Foille Ole Cutaneous Spray, Solution
- Contents of the pack and other information
1. What Foille Sole cutaneous spray, solution is and what it is used for
Foille Sole cutaneous spray, solution is a topical medicinal product containing benzocaine (capable of relieving pain, burning, and itching of the skin), benzyl alcohol (with antiseptic action and able to soothe pain), and chloroxylenol (with antiseptic action).
Foille Sole cutaneous spray, solution is used:
in cases of skin redness due to excessive and prolonged sun exposure (sunburns), minor burns, skin irritations caused by various chemical-physical agents, and insect bites;
for the treatment of superficial skin lesions (excoriations and abrasions) and superficial wounds.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you should 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
Talk to your doctor or pharmacist before using Foille Sole cutaneous spray, solution.
Foille Sole cutaneous spray, solution is intended for topical use only (on the skin), on limited superficial lesions and for a short period of time only.
Use this medicine only after consulting your doctor in the following cases:
- if you have deep wounds, multiple insect bites, blisters with fluid, or if the skin surface is burned (severe burns) or has 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 near flames or hot surfaces. Do not inhale: prolonged inhalation of Foille Sole cutaneous spray, solution may cause dizziness and feelings of discomfort.
The efficacy and safety of benzocaine depend on correct dosing; therefore, use the smallest amount of medicine sufficient to achieve pain relief.
Apply Foille Sole cutaneous spray, solution with caution if you have severely damaged mucous membranes or skin redness (inflammation), to avoid excessive absorption of benzocaine into the body.
Avoid prolonged use of Foille Sole cutaneous spray, solution, especially over large skin areas.
The use, particularly if prolonged, of topical medicines on the skin may lead to irritation or allergic reactions (sensitization). If this occurs, discontinue treatment and consult your doctor for appropriate therapy.
If the lesion does not improve within a few days, or if redness, pain, or swelling worsens or signs of infection appear, stop using the medicine and consult your doctor immediately.
Consult your doctor also if such symptoms have occurred previously.
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 using, have recently used, or might use any other medicines.
No interactions with other medicines are currently known for Foille Sole cutaneous spray, solution.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 or operate machinery.
Foille Sole cutaneous spray, solution contains propylene glycol
This medicine contains 700 mg of propylene glycol per package (70 g), equivalent to 10 mg/g.
Foille Sole cutaneous spray, solution contains ethanol
This medicine contains 58.19 g of alcohol (ethanol) per package (70 g), 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 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, both in adults and children, is up to a maximum of 4 applications per day.
Warning: Do not exceed the recommended doses.
Instructions for use
For application, carefully follow the instructions below:
1 shake the bottle and then remove the cap;
2 direct the spray nozzle towards the area to be treated, keeping it approximately one hand's breadth away;
3 press the spray nozzle to obtain a thin, even layer.
If there is no improvement after a short period of treatment, consult your doctor.
Also consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics (see "Warnings and precautions").
If you use more Foille Sole cutaneous spray, solution than you should
In case of accidental ingestion/overdose of Foille Sole cutaneous spray, solution, contact your doctor immediately or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and elderly patients, may rarely cause a bluish discoloration of the skin and mucous membranes (cyanosis); in such cases, go to the nearest hospital (see "Possible side effects").
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 can cause side effects, although not everybody will experience them.
The use of Foille Sole cutaneous spray, solution, especially if prolonged, may lead to allergic reactions (sensitization), resulting in redness and itching. If this occurs, stop treatment and consult your doctor for appropriate therapy.
Rarely, high absorption of benzocaine may cause, particularly in children and elderly patients, a bluish discoloration (cyanosis), especially noticeable on the lips and fingers. In such case, seek immediate medical attention at the nearest hospital.
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 Foille Sole cutaneous spray, solution
Keep this medicine out of 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.
Store below 25°C. Keep the container in the outer packaging to protect the medicine from light.
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 Foille Sole cutaneous spray, solution contains
- The active substances 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 components are: ethanol 96%, PPG20 methyl glucose ether, ammonium spirit, glycerol, propylene glycol.
Description of the appearance of Foille Sole cutaneous spray, solution and contents of the pack
Container of 70 g.
Marketing Authorization 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)
Authorized distributor for sale
Vemedia Pharma S.r.l. – Parma