Package leaflet: Information for the patient

Foille Insetti 0.5 g/100 g cream

Hydrocortisone
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What Foille Insetti is and what it is used for
What you need to know before using Foille Insetti
How to use Foille Insetti
Possible side effects
How to store Foille Insetti
Contents of the pack and other information

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

Foille Insect is a topical medicine containing hydrocortisone, an anti-inflammatory.
This medicine is used to treat conditions caused by insect bites, itching, skin redness (erythema), and skin inflammation (eczema).
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 Insetti

Do not use Foille Insetti

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

Warnings and precautions
Talk to 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 over large areas of skin.
The use, particularly if prolonged, of topical skin products may cause irritation or allergic reactions (sensitization). If this occurs, stop treatment and consult your doctor, who will provide appropriate management.
If skin irritation occurs, discontinue treatment.
If you have or may have pheochromocytoma (a benign tumour frequently located in the adrenal gland), consult your doctor, who will advise whether you can take this medicine. In patients with pheochromocytoma, administration of corticosteroids (medicines of the same class as hydrocortisone) may cause pheochromocytoma crisis, which can be life-threatening.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
In children under 2 years of age, Foille Insetti should be used only after consulting a doctor.
Other medicines and Foille Insetti
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions are known to occur with the administration of Foille Insetti together with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
During pregnancy and breastfeeding, use Foille Insetti only after consulting your doctor.
Driving and using machines
Foille Insetti does not affect alertness; therefore, it does not impair the ability to drive or operate machinery.
Foille Insetti contains cetyl alcohol, stearyl alcohol and lanolin
This medicine contains cetyl alcohol, stearyl alcohol and lanolin, which may cause localized skin reactions (e.g. contact dermatitis).

3. How to use Foille Insetti

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.
Adults and children over 2 years of age: apply a thin layer of cream to the affected area, gently massaging it in, twice daily.
Caution: do not exceed the recommended doses. Use only for short-term treatment.
If your condition does not improve after a short period of treatment, consult your doctor.
Consult your doctor if the condition recurs repeatedly or if you notice any recent changes in its characteristics.
If you use more Foille Insetti than you should
In case of accidental ingestion/overdose of Foille Insetti, contact your doctor immediately 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 will experience them.
As with all medicines applied to the skin (topical use), local sensitization reactions (allergy) may occur.
In general, applying medicines similar to this one (corticosteroids) to the skin does not result in obvious disturbances due to absorption into the body (systemic absorption). However, when applied over large areas of skin, for prolonged periods of time, on damaged skin, or under occlusive dressing (using the medicine with an airtight or waterproof dressing), this medicine may be absorbed in sufficient amounts to produce effects on the body.

The following side effects have been reported in patients treated with hydrocortisone or medicines of the same class.
Frequency not known (frequency cannot be estimated from the available data):

blurred vision;
choroidoretinopathy (a disease of the retina);
in patients with phaeochromocytoma (a benign tumour frequently located in the adrenal gland), phaeochromocytoma crisis may occur, which can be life-threatening (see section 4.4);
urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Insect

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 Insetti contains

The active substance is hydrocortisone. 100 g of cream contain 0.5 g of hydrocortisone.
The other components are: isopropyl alcohol, cetyl alcohol, stearyl alcohol, lanolin, stearate macrogol 1000, stearate macrogol 4000, stearate macrogol 6000, bitter almond flavor, and purified water.

Description of the appearance of Foille Insetti and contents of the pack
Foille Insetti is a cream supplied in a 15 g tube.
Marketing Authorization Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands
Marketing Authorization Holder's Representative
Vemedia Pharma S.r.l – Parma
Manufacturer
Sanofi Winthrop Industrie – F-45200 Amilly (France)