Foille scottature
Italy
Table of Contents
Package leaflet: Information for the patient
Foille Scottature cream
benzyl alcohol, benzocaine, chloroxylenol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- 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 Scottature is and what it is used for
- What you need to know before using Foille Scottature
- How to use Foille Scottature
- Possible side effects
- How to store Foille Scottature
- Contents of the pack and other information
1. What Foille Scottature is and what it is used for
Foille Scottature is a topical medicine containing benzocaine (which relieves pain, burning, and itching of the skin), benzyl alcohol (with antiseptic and pain-relieving properties), and chloroxylenol (with antiseptic action).
Foille Scottature is used:
- for skin redness caused by excessive and prolonged sun exposure (solar erythema), minor burns, skin irritations due to various chemical-physical agents, and insect bites;
- for the treatment of superficial skin lesions (excoriations and abrasions) and minor skin 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 Scottature
Do not use Foille Scottature
- 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 Scottature.
Foille Scottature is intended for topical use only (on the skin), for superficial, non-extensive lesions and for short-term use only.
Use this medicine only after consulting your doctor in the following cases:
- if you have deep or severe wounds, multiple insect bites,
- when a blister with fluid forms or the skin surface appears burned (severe burns) or mild burns that are particularly extensive;
- 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 efficacy and safety of benzocaine depend on correct dosing; therefore, use the smallest amount of medicine sufficient to achieve pain relief.
Apply Foille Scottature 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 Scottature, especially over large skin areas. The use, particularly if prolonged, of medicines on the skin (topical products) 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 after a few days, or if redness, pain, or swelling worsens, or if 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 Scottature 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 Scottature
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between Foille Scottature and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use Foille Scottature only after consulting your doctor.
Driving and using machines
Foille Scottature has no effect on the ability to drive vehicles or operate machinery.
Foille Scottature contains sodium lauryl sulfate
This medicine contains 60 mg of sodium lauryl sulfate per 100 g of cream, equivalent to 0.6 mg/g.
Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.
Foille Scottature contains eugenol
This medicine contains the allergen eugenol, which may cause allergic reactions.
3. How to use Foille Scottature
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.
Apply a thin, even layer of cream directly to the affected area. In the case of small lesions, after applying the cream, cover the area with a sterile gauze dressing.
If using a sterile gauze, do not remove the dressing before 48 hours to avoid interfering with the healing process. It is also possible not to remove the sterile gauze for several days: in such cases, keep the dressing moist by applying Foille Scottature directly onto the sterile gauze.
If there is no improvement after a short period of treatment, consult your doctor.
Also consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics (see "Warnings and precautions").
If you use more Foille Scottature than you should
In case of accidental ingestion or overdose of Foille Scottature, 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 doubts about how to use 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 Scottature, especially if prolonged, may lead to allergic reactions (sensitization), resulting in redness and itching. If this occurs, discontinue treatment and consult your doctor for appropriate therapy.
Rarely, excessive absorption of benzocaine may cause cyanosis—appearing as a bluish discoloration particularly noticeable on the lips and fingers—especially in children and elderly individuals. In such cases, 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, consult 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 further information on the safety of this medicine.
5. How to store Foille Scottature
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 25°C.
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 Scottature 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 0.1 g of chloroxylenol.
- The other components are: hydrogenated vegetable oil, solid paraffin, yellow beeswax, higher fatty acid monoglycerides, corn oil, calcium hydroxide, sodium borate, PEG 32, sodium lauryl sulfate, eugenol, calcium disodium EDTA, 8-hydroxyquinoline, purified water.
Description of the appearance of Foille Scottature and contents of the pack
Foille Scottature is a cream.
The pack contains a 29.5 g tube.
Marketing Authorization Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (The Netherlands)
Sales Licensee
Vemedia Pharma S.r.l – Parma
Manufacturer
Sanofi Winthrop Industrie – F-45200 Amilly (France)