Active ingredients: Benzyl alcohol, benzocaine, chloroxylenol
Foille Sole cream
Foille Sole cutaneous spray, solution
Why is Foille sole used? What is it for?
Foille Sole is a medicine to be used on the skin, which contains benzocaine (capable of relieving pain, burning and itching on the skin), benzyl alcohol (with disinfectant action and capable of calming pain) and chlorine xylenol (with disinfectant action)
Foille Sole is used:
- in case of skin redness due to excessive and prolonged exposure to the sun (sunburn), small burns, skin irritations from various chemical-physical agents, insect bites;
- in the dressing of superficial lesions (excoriations and abrasions) and superficial skin wounds.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Foille sole should not be used
Do not use Foille Sole
- 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.
Precautions for use What you need to know before taking Foille sole
Talk to your doctor or pharmacist before using Foille Sole.
Foille Sole should only be used on the skin (for external use), on non-extensive superficial lesions and for a short period of time.
In the following cases, always use this medicine only after consulting your doctor:
- if you have deep wounds, numerous insect bites, when a blister with liquid forms or the surface of the skin is burned (severe burns)) or particularly extensive minor 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 eyes.
For the spray formulation, do not vaporize on a flame or incandescent bodies. Do not inhale. Continuous inhalation of Foille Sole spray can induce dizziness and a feeling of malaise.
The efficacy and safety of benzocaine depend on a correct dosage, therefore you must use the minimum quantity of medicine sufficient to obtain the improvement of the pain.
Apply Foille Sole with caution if you have severely damaged mucous membranes or in the presence of redness (inflammation), in order to avoid excessive absorption into the body of benzocaine.
Avoid prolonged use of Foille Sole, especially on large surfaces. The use, especially if prolonged, of medicines on the skin (topical products) can give rise to phenomena of irritation or allergy (sensitization). In this case, stop the treatment and consult your doctor in order to receive a suitable therapy .
If the injury does not improve after a few days, if the redness, pain or swelling gets worse, or if an infection occurs, stop using the medicine and see your doctor right away. Also consult your doctor if these problems have occurred in the past.
Children
Foille Sole 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").
Interactions Which drugs or foods can modify the effect of Foille sole
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known disorders (interactions) related to the association between Foille Sole and other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breastfeeding, use Foille Sole only after consulting your doctor.
Driving and using machines
Foille Sole has no effect on the ability to drive and use machines.
Foille Sole cream contains cetyl alcohol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate (parabens) and butyl hydroxyanisole (E320)
The presence of cetyl alcohol can cause local skin reactions (e.g. contact dermatitis), methyl p-hydroxybenzoate and propyl p-hydroxybenzoate can cause skin reactions (including delayed type). The presence of butylhydroxyanisole can cause skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Foille Sole spray contains propylene glycol
The presence of propylene glycol could cause skin irritation.
Foille Sole spray contains ethyl alcohol
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Dose, Method and Time of Administration How to use Foille sole: Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, 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.
How to use
Foille Sole cream: apply a light and even layer of cream directly on the lesion. In case of small lesions following the application of the cream, cover the lesion with sterile gauze.
If you are using sterile gauze, do not remove the dressing for 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 Scottature directly on the sterile gauze.
Foille Sole spray: in case of more extensive lesions it is preferable to use the spray.
For the application, carefully follow the instructions below:
- shake the bottle and then remove the cap;
- direct the hole of the dispensing valve towards the area to be treated, keeping it about a palm away;
- press the dispensing valve, in order to obtain a light and uniform layer.
If you do not see improvement after a short period of treatment, please contact your doctor.
Also consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics (see "Warnings and precautions").
Overdose What to do if you have taken too much Foille sole
In case of accidental ingestion / intake of an excessive dose of Foille Sole, notify your doctor immediately or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and the elderly, may rarely lead to a bluish discoloration of the skin and mucous membranes (cyanosis), in which case contact the nearest hospital (see "Possible side effects").
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Foille sole
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of Foille Sole, especially if prolonged, can give rise to allergy phenomena (sensitization), with the appearance of redness and itching. In this case, stop the treatment and contact your doctor to receive a suitable therapy.
Rarely, a high absorption of benzocaine can cause, particularly in children and the elderly, a particularly evident bluish color (cyanosis) on the lips and fingers. In this case, please contact the nearest hospital.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 package after EXP. The expiry date refers to the last day of that month.
Foille Sole cream: Store below 30 ° C.
Foille Sole spray: Store below 25 ° C. Keep away from light.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Foille Sole contains
Cream
- 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 ingredients are: stearic acid, cetyl alcohol, glycerin, petroleum jelly, isopropyl myristate palmitate and stearate, polysorbate 60, cocoa butter, triethanolamine, carbomer 974P, sorbitan tristearate, methyl p-hydroxybenzoate, eugenol, propyl p-hydroxybenzoate, buthydroxybenzoate , purified water.
Spray
- The active ingredients are: benzyl alcohol, benzocaine and chloroxylenol. 100 g of spray contains 4 g of benzyl alcohol, 5 g of benzocaine and 0.6 g of chloroxylenol
- The other ingredients are: 96% ethanol, PPG20 methylglucose ether, ammonium spirit, glycerol, propylene glycol.
Description of the appearance of Foille Sole and contents of the pack
Foille Sole comes as a dermatological cream or spray.
The contents of the cream pack is a 30 g tube.
The contents of the spray package is a 70 g container.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FOILLE SOLE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principles: Benzyl alcohol 4 g - Benzocaine 5 g - Chloroxylenol 0.4 g.
Excipient (s) with known effects: cetyl alcohol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate (parabens) and butyl hydroxyanisole (E320)
100 g of spray contains:
Active principles: Benzyl alcohol 4 g - Benzocaine 5 g - Chloroxylenol 0.6 g.
Excipient (s) with known effects: ethanol and propylene glycol
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
Skin spray, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Minor burns, sunburn, skin irritation from various chemical-physical agents, insect bites. In the dressing of excoriations, abrasions and superficial skin wounds.
04.2 Posology and method of administration
Cream: apply the cream, in a thin and uniform layer, directly on the lesion. In case of limited lesions it is advisable - following the application of the cream - to cover with sterile gauze, kept moist with further applications from the outside and to bandage carefully. The dressing should not be removed before 48 hours, in order not to disturb the granulation process. In some cases the initial dressing will not have to be removed and changed even for a longer period of time, but it must gradually be kept well moistened with FOILLESOLE.
It is recommended not to exceed the maximum limit of 4 applications per day, in both adults and children.
Spray: In case of more extensive lesions, it is preferable to use the spray.
When using FOILLESOLE cutaneous spray, solution, the following instructions must be carefully observed:
1. shake the can and then remove the protective cap;
2. direct the hole of the dispensing valve towards the area to be treated, keeping it at a distance of about a palm.
3. press the dispensing valve.
It is recommended not to exceed the maximum limit of 4 applications per day, both in adult patients and in children.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
The product cannot be used for ophthalmic use.
04.4 Special warnings and appropriate precautions for use
FOILLESOLE is for external use only and must be used only on superficial and not extensive lesions of the skin, and for short periods of time.
In case of deep wounds, or disseminated insect bites, or severe burns or particularly extensive minor burns, always consult your doctor before using the product. If the morbid condition for which this preparation is used persists longer, if irritation develops, if redness, swelling or pain persists, or if you have an infection, discontinue use and consult your doctor.
Do not apply near the eyes. Do not vaporize on flames or incandescent bodies. Do not inhale: the continuous inhalation of FOILLE SOLE spray can induce the onset of dizziness and feelings of malaise, typical of any aerosol product.
The use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case, treatment must be stopped immediately and suitable therapy instituted.
The efficacy and safety of benzocaine depend on a correct dosage. Therefore it is necessary to use the minimum quantity of product sufficient to obtain the desired effect. excessive absorption of this active ingredient. Do not use the product in children under 6 months of age; administration is recommended only after consulting your doctor between 6 months and 2 years of age.
FOILLE SOLE cutaneous spray contains the excipient ethanol (ethyl alcohol). For those who carry out sports activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations.
The presence of cetyl alcohol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, as excipients of the cream formulation, and of propylene glycol, as excipient of the spray formulation, can be responsible for localized skin reactions (also of the delayed type).
The presence of butylhydroxyanisole as an excipient of the cream formulation can be responsible for localized skin reactions (eg contact dermatitis) or irritation to the eyes and mucous membranes.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and breastfeeding
There are no known contraindications for the use of FOILLE SOLE during pregnancy or breastfeeding; it is however advisable to consult your doctor before taking the drug during pregnancy.
04.7 Effects on ability to drive and use machines
FOILLE SOLE does not influence the state of vigilance; therefore it has no effect on the ability to drive and use machines.
04.8 Undesirable effects
The use of products for topical application, especially if prolonged, can give rise to sensitization phenomena. In this case, stop the treatment and institute a suitable therapy.
Rarely, a high absorption of benzocaine can cause serious reactions (increased methemoglobin, with the appearance of cyanosis), particularly in children and the elderly, which require prompt hospital intervention.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Rare cases of increased methemoglobin related to excessive absorption of benzocaine have been reported in the literature, particularly in children and the elderly. In the event of cyanosis, contact the nearest hospital for appropriate therapy (supportive therapy and intravenous administration of methylene blue).
In case of accidental ingestion, it is advisable to implement the normal medical measures recommended in case of intoxication.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: dermatologicals - local anesthetics.
ATC code: D04AB04.
FOILLE SOLE is a water-soluble medicinal product containing benzocaine, benzyl alcohol and chloroxylenol as active ingredients.
Benzocaine is an ester type local anesthetic. It works by reversibly blocking nerve conduction first in the nerve fibers of the autonomic compartment, then sensory and, finally, motor. Benzocaine acts promptly by relieving pain, burning and itching in the skin.
Benzyl alcohol has antiseptic and analgesic properties and tends to prevent secondary infections, thanks to its bacteriostatic effects.
Chloroxylenol assists this last action with its local antiseptic activity. It is a common constituent of many disinfectants used for skin and wound disinfection.
05.2 Pharmacokinetic properties
Benzocaine, thanks to its low solubility in the aqueous medium, is poorly absorbed; this accounts for its low systemic toxicity. It is metabolized by hydrolysis to 4-aminobenzoic acid. Renal excretion is minimal and occurs in unchanged form.
Benzyl alcohol is metabolised to benzoic acid. It is then conjugated with glycine in the liver to form hippuric acid, excreted in the urine.
Chloroxylenol is partially absorbed in the gastrointestinal tract. It is conjugated with glucuronic acid and sulfuric acid; no further data are available. 1/3 of the ingested dose is excreted in the urine.
05.3 Preclinical safety data
BENZOCAINE: at the concentrations normally used (2-10%), it is relatively non-irritating and non-toxic.
There are no experimental studies on carcinogenicity, mutagenicity / genotoxicity and reproductive toxicity.
BENZYL ALCOHOL: the WHO has set an estimated daily limit for the daily intake of benzyl / benzoic compounds up to 5 mg / kg / day of body weight.
In rabbits, it has not been shown to cause irritative effects on the skin (evaluation according to OECD 404 method), while it has been shown to cause a modest irritative effect on the eyes (evaluation according to OECD 405 method). Chronic exposure to benzyl alcohol can cause dermatitis.
Mutagenicity (Ames test) and carcinogenicity studies gave negative results.
CHLOROXYLENOL: is generally considered to be relatively non-toxic and non-irritating when used as an excipient in topical products. However, chloroxylenol has been classified in Toxicity Category I for its irritating effects on the eye. Allergic skin reactions are also reported. When taken orally, it is moderately toxic; ingestion of disinfectant products containing chloroxylenol has been associated with poisoning. lethal, or very severe.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cream: 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, butylhydroxyanol.
Spray: ethanol 96%, glucam P 20 (PPG 20 methylglucose ether), ammonium spirit, glycerol, propylene glycol.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
FOILLE SOLE cream: 3 years
FOILLE SOLE cutaneous spray, solution: 3 years
06.4 Special precautions for storage
FOILLE SOLE cream: Store at a temperature below 30 ° C.
FOILLE SOLE cutaneous spray, solution: Store below 25 ° C. Keep away from light.
06.5 Nature of the immediate packaging and contents of the package
Cream: 30 g tube;
Skin spray, solution: 70 g container.
06.6 Instructions for use and handling
No particular precautions.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / b - IT-20158 Milan (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
FOILLE SOLE cream AIC 027546011
FOILLE SOLE cutaneous spray, solution 70 g AIC 027546023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
FOILLE SOLE cream - Date of first authorization: 17 December 1991
- Date of most recent renewal: 1 June 2010
FOILLE SOLE cutaneous spray, solution 70 g - Date of first authorization: 17 December 1991 - Date of most recent renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
February 2017
