Foille Sunburn - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Benzyl alcohol, benzocaine, chloroxylenol

Foille Sunburn cream

Why is Foille Sunburn 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 Sunburn 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 Sunburn should not be used

Do not use Foille Sunburn if you are allergic to benzyl alcohol, benzocaine, chloroxylenol or any of the other ingredients of this medicine.

This medicine should not be applied to the eyes.

Precautions for use What you need to know before taking Foille sunburn

Talk to your doctor or pharmacist before using Foille Sunburn.

Foille Burns 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 or severe 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.

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 Sunburn with caution if you have severely damaged mucous membranes or in the presence of redness (inflammation), to avoid excessive absorption of benzocaine into the body.

Avoid prolonged use of Foille Sunburn, 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 Sunburn is not for use in children younger than 6 months. 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 sunburn

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 Burns 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 Sunburn only after consulting your doctor.

Driving and using machines

Foille Sunburn has no effect on the ability to drive and use machines.

Dose, Method and Time of Administration How to use Foille scalds: 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.

Apply a light, even layer of cream directly to 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.

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 an overdose of Foille sunburn

In case of accidental ingestion / intake of an overdose of Foille Scalds, notify your doctor immediately or go to the nearest hospital.

Excessive absorption of benzocaine into the body, particularly in children and the elderly, can rarely lead to a bluish discoloration of the skin and mucous membranes (cyanosis); in these cases, please 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 sunburn

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of Foille Burns, 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, the appearance of cyanosis, or a particularly evident bluish color 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. The expiry date refers to the last day of that month.

Store below 25 ° C.

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 Sunburn 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 0.1 g of chloroxylenol.
  • The other ingredients are: hydrogenated vegetable oil, solid paraffin, yellow beeswax, monodiglycerides of higher fatty acids, corn oil, calcium hydrate, sodium borate, PEG 32, sodium lauryl sulfate, maleic anhydride, eugenol, sodium calcium EDTA, 8 -hydroxyquinoline, purified water.

Description of how Foille Sunburn looks and contents of the package

Foille Sunburn comes as a cream. The contents of the package is a 29.5 g tube.

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.

More information on Foille Sunburn can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

FOILLE BURN CREAM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g of cream contain:

Active principles:

benzyl alcohol 4 g

benzocaine 5 g

chloroxylenol 0.10 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Cream.

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

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. The dressing should not be removed for at least 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 must gradually keep it well moistened with FOILLE SCOTTATURE.

It is recommended not to exceed the maximum limit of 4 applications per day, in both adults and children.

04.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

The product is not suitable for ophthalmic use.

04.4 Special warnings and appropriate precautions for use

FOILLE SCOTTATURE is for external use only.

The use, especially if prolonged, of the product can give rise to sensitization phenomena.

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, applying it with caution in subjects with severely damaged mucous membranes and site of inflammatory processes that could cause absorption. excessive of this active ingredient.

FOILLE SCOTTATURE should only be used on non-extensive and superficial skin lesions and for short periods of time.

Do not apply near the eyes.

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 use the product in children under the age of 6 months; administration is recommended only after consulting your doctor between 6 months and 2 years of age.

04.5 Interactions with other medicinal products and other forms of interaction

None known.

04.6 Pregnancy and breastfeeding

There are no known contraindications to use in case of pregnancy or breastfeeding. However, it is advisable to consult your doctor before taking the drug during pregnancy and breastfeeding.

04.7 Effects on ability to drive and use machines

FOILLE SCOTTATURE does not influence the state of vigilance; therefore it does not affect the ability to drive or 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.

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 SCOTTATURE combines the antiseptic and anesthetic properties of its active ingredients and gives quick relief from superficial pain and itching and with its bactericidal action it controls infections.

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 works 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. Like other local anesthetics, it is metabolized by plasma cholinesterases to 4-aminobenzoic acid. Renal excretion is minimal and occurs in unchanged form.

Benzyl alcohol is metabolised to benzoic acid; the latter is conjugated with glycine in the liver to form hippuric acid, which is 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 the maximum daily intake limit for benzyl / benzoic groups at 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

Hydrogenated vegetable oil, ceresin (solid paraffin), yellow beeswax, monodiglycerides (of higher fatty acids), corn oil, calcium hydrate, sodium borate, PEG 32, sodium lauryl sulfate, maleic anhydride, eugenol, sodium calcium EDTA, 8 -hydroxyquinoline, purified water.

06.2 Incompatibility

Not relevant.

06.3 Period of validity

2 years.

06.4 Special precautions for storage

Store below 25 ° C.

06.5 Nature of the immediate packaging and contents of the package

Cream, tube 29.5 g.

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

AIC 006228062

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

12 October 1976/1 June 2010

10.0 DATE OF REVISION OF THE TEXT

October 2014

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

Tags:  toxicity-and-toxicology supplements skin-health