FOILLE SKOTTATURE 29.5 G Cream

Зміст інструкції

1. Foille cottature crema
   1. What is Foille Scottature and what is it used for
   2. What you need to know before using Foille Scottature
   3. How to use Foille Scottature
   4. Possible side effects
   5. How to store Foille Scottature
   6. Contents of the pack and other information

Foille cottature crema

benzyl alcohol, benzocaine, chloroxylenol

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What Foille Scottature is and what it is used for
• 2. What you need to know before using Foille Scottature
• 3. How to use Foille Scottature
• 4. Possible side effects
• 5. How to store Foille Scottature
• 6. Contents of the pack and other information

1. What is Foille Scottature and what is it used for

Foille Scottature 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
soothing pain) and chloroxylenol (with a disinfectant action).
Foille Scottature is used:

• in case of skin redness due to excessive and prolonged exposure to the sun (sunburns), minor burns, skin irritations from various chemical-physical agents, insect bites;
• in the dressing of superficial lesions (abrasions and excoriations) and superficial 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
Consult your doctor or pharmacist before using Foille Scottature.
Foille Scottature should only be used on the skin (for external use), on superficial, non-extensive lesions and for a short period of time.
In the following cases, use this medicine only after consulting your doctor:

• if you have deep or severe wounds, numerous insect bites,
• when a blister with fluid forms or the skin surface is burned (severe burns) or particularly extensive mild burns;

severe 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 dosage, therefore you must use the minimum amount of medicine sufficient to achieve pain relief.
Apply Foille Scottature with caution if you have severely damaged mucous membranes or in the presence of redness (inflammation), in order to avoid excessive absorption of benzocaine into the body.
Avoid prolonged use of Foille Scottature, especially on large areas. The use, especially if prolonged, of medicines on the skin (topical products) can give rise to irritation or allergic reactions (sensitization). In such cases, discontinue treatment and consult your doctor in order to receive appropriate therapy.
If the lesion does not improve after a few days, if the redness, pain or swelling worsen or if infection occurs, stop using the medicine and consult your doctor immediately.
Also consult your doctor in cases where these disorders have occurred in the past.

Children
Foille Scottature 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”).

Other medicines and Foille Scottature
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No disturbances (interactions) related to the association between Foille Scottature and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice 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 and operate machines.

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 can cause skin irritation (tingling 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 following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, 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 and uniform layer of cream directly to the lesion. In case of small lesions
following application of the cream, cover the lesion with sterile gauze.
If you use sterile gauze, do not remove the dressing before 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 to the sterile gauze.
If you do not observe an improvement after a short period of treatment, consult your doctor.
Also, consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics (see “Warnings and precautions”).

If you use more Foille Scottature than you should
In case of ingestion/accidental intake of an excessive dose of Foille Scottature, immediately notify
your doctor or go to the nearest hospital.
Excessive absorption of benzocaine into the body, particularly in children and the elderly, can
rarely cause a bluish discoloration of the skin and mucous membranes (cyanosis); in these cases, go
to the nearest hospital (see “Possible side effects”).
If you have any doubts 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 Scottature, especially if prolonged, may give rise to allergic reactions
(sensitization), with the appearance of redness and itching. In this case, discontinue treatment and
consult your doctor to receive appropriate therapy.
Rarely, high absorption of benzocaine can cause, particularly in children and the elderly, the
appearance of cyanosis, that is, a bluish discoloration particularly evident on the lips and
fingers. In this case, go to the nearest hospital.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through 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 Scottature

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Foille Scottature contains

• The active ingredients 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, monoglycerides of higher fatty acids, corn oil, hydrated calcium, sodium borate, PEG 32, sodium lauryl sulfate, maleic anhydride, eugenol, sodium calcium EDTA, 8-hydroxyquinoline, purified water.

Description of the appearance of Foille Scottature and contents of the pack
Foille Scottature is presented as a cream.
The pack contains a tube of 29.5 g.

Marketing Authorisation Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (Netherlands)

Distributor for sales
Vemedia Pharma S.r.l – Parma

Manufacturer
Sanofi Winthrop Industrie – F-45200 Amilly (France)