FOILLE 0.5 G Krem

Treść ulotki

1. Foille Insetti 0.5 g/100 g cream
   1. What is Foille Insetti and what is it used for?
   2. What you need to know before using Foille Insetti
   3. How to use Foille Insetti
   4. Possible side effects
   5. How to store Foille Insetti
   6. Contents of the pack and other information

Foille Insetti 0.5 g/100 g cream

Hydrocortisone

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

1. What is Foille Insetti and what is it used for?

Foille Insetti is a medicine to be applied to the skin that contains hydrocortisone, an
anti-inflammatory.
This medicine is used for the treatment of disorders caused by insect bites, itching,
skin redness (erythema) and skin inflammation (eczema).
See a 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 Insetti

Do not use Foille Insetti

• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6);
• if you have a viral, bacterial or fungal infection.

Warnings and precautions
Consult your doctor or pharmacist before using Foille Insetti.
Use only on the skin (for external use). Do not apply to mucous membranes. Avoid contact with the
eyes.
Avoid prolonged use of Foille Insetti, especially on large areas.
The use, especially if prolonged, of products on the skin (topical) can give rise to phenomena of
irritation or allergies (sensitization). In such cases, stop treatment and consult your
doctor who will provide the necessary remedies.
If skin irritation appears, discontinue treatment.
If you suffer from or may suffer from pheochromocytoma (a benign tumor frequently
located in the adrenal gland), consult your doctor who will tell you if you can take this
medicine. In patients with pheochromocytoma, the administration of corticosteroids (medicines
of the same class as hydrocortisone) can cause pheochromocytoma crises that can put you in
danger of life.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
In children under 2 years of age, Foille Insetti should only be used after consulting a
doctor.

Other medicines and Foille Insetti
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No disturbances (interactions) are known caused by the administration of Foille Insetti with other
medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
During pregnancy and breastfeeding, use Foille Insetti only after consulting your doctor.

Driving and operating machinery
Foille Insetti does not affect the state of vigilance, therefore it does not alter the ability to drive vehicles and
use machinery.

Foille Insetti containscetyl alcohol, stearyl alcohol and lanolin
This medicine contains cetyl alcohol, stearyl alcohol and lanolin which can cause
localized skin reactions (e.g. contact dermatitis).

3. How to use Foille Insetti

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 2 years of age:apply a thin layer of cream to the affected area, massaging lightly, twice a day.

Attention: do not exceed the indicated doses. Use only for short periods of treatment. If your condition does not improve after a short period of treatment, consult your doctor. Consult your doctor if the condition recurs or if you notice any recent change in its characteristics.

If you use more Foille Insetti than you should
In case of ingestion/accidental intake of an excessive dose of Foille Insetti, immediately notify your doctor or go to the nearest hospital.
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.
As with all medicines used on the skin (for topical use) it is possible to experience
local sensitisation reactions (allergy).
In general, applying medicines similar to this one (corticosteroids) to the skin does not
cause significant disorders due to absorption into the body (systemic absorption). When
applied to extensive areas, or for prolonged periods of time, or to diseased skin, or in case of
occlusive bandaging (use of the medicine with a waterproof bandage), this medicine can
be absorbed in sufficient quantities to cause effects on the body.
In patients treated with hydrocortisone or with medicines of the same class, the following side
effects have been reported.

Frequency not known(frequency cannot be estimated based on available data):

• blurred vision;
• chorioretinopathy (a disease of the retina);
• in patients affected by pheochromocytoma (a benign tumour frequently located in the adrenal gland) pheochromocytoma crises may occur which can be life-threatening (see section 4.4);
• urticaria.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Foille Insetti

Keep this medicine out of the sight and reach of children.

Do not use this medicine afterthe 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 waste water 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 Insetti contains

• The active ingredient is hydrocortisone. 100 g of cream contains 0.5 g of hydrocortisone.
• The other ingredients are: isopropyl alcohol, cetyl alcohol, stearyl alcohol, lanolin, macrogol 1000 stearate, macrogol 4000 stearate, macrogol 6000 stearate, bitter almond aroma and purified water.

Description of the appearance of Foille Insetti and contents of the pack
Foille Insetti is a cream contained in a 15 g tube.

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)