FOILLE SOLE CREAM 1 TUBE OF 30 G

Name
Foille Sole cream
Benzyl alcohol, benzocaine, chloroxylenol


What is it and what is it 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 redness of the skin due to excessive and prolonged exposure to the sun (sunburn), small burns, skin irritations caused by various chemical-physical agents, insect bites;
• in the dressing of superficial lesions (grazes and abrasions) and superficial skin wounds.

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
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
Talk to your doctor or pharmacist before using Foille Sole cream.

Foille Sole cream should only be used on the skin (for cutaneous use), on superficial, non-extensive 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 fluid 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 effectiveness and safety of benzocaine depend on correct dosing, so you should use the smallest amount of medicine needed to achieve pain relief.

Apply Foille Sole cream with caution if you have severely damaged mucous membranes or if you experience redness (inflammation), so as to avoid excessive absorption of benzocaine into the body.

Avoid prolonged use of Foille Sole cream, especially on large surfaces.

The use of medications on the skin (topical products), especially if prolonged, can cause irritation or allergy (sensitization). If this occurs, discontinue use and consult your doctor for appropriate treatment.

If the lesion does not improve after a few days, if the redness, pain or swelling worsens or if an infection occurs, stop using the medicine and contact your doctor immediately.

Consult your doctor even if 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”).


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

Use of Foille Sole, especially if prolonged, may cause allergic reactions (sensitization), with the appearance of redness and itching. If this occurs, discontinue use and consult your doctor for appropriate treatment.

Rarely, excessive benzocaine absorption can cause a bluish discoloration (cyanosis), particularly noticeable on the lips and fingers, especially in children and the elderly. If this occurs, contact your nearest hospital.

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.