Active ingredients: Hydrocortisone
Foille Insects 0.5 g / 100g cream
Why is Foille Insect used? What is it for?
Foille Insetti is a medicine to be applied to the skin that contains hydrocortisone, an anti-inflammatory. This medicine is used to treat ailments caused by insect bites, itching, redness of the skin (erythema) and inflammation of the skin (eczema).
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment
Contraindications When Foille Insects should not be used
Do not use Foille Insects
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine;
- if you have a viral, bacterial or fungal infection.
Precautions for use What you need to know before taking Foille Insects
Talk to your doctor or pharmacist before using Foille Insetti. Use on the skin only (for external use). Do not apply to mucous membranes.
Avoid contact with eyes. Avoid prolonged use of Foille Insects, especially on large surfaces.
The use, especially if prolonged, of the products on the skin (topical) can give rise to phenomena of irritation or allergies (sensitization). In this case, stop the treatment and consult your doctor who will provide the necessary remedies.
If skin irritation appears, stop the treatment.
If you have or may have pheochromocytoma (a benign tumor frequently found in the adrenal gland), please contact your doctor who will tell you if you can take this medicine. In patients with pheochromocytoma, administration of corticosteroids (medicines of the same class as hydrocortisone) can cause life-threatening pheochromocytoma crises.
Children
In children under 2 years of age Foille Insetti should only be used after consulting your doctor.
Interactions What drugs or foods can modify the effect of Foille insects
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known disorders (interactions) caused by the administration of Foille Insetti with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
During pregnancy and breastfeeding use Foille Insetti only after consulting your doctor.
Driving and using machines
Foille Insetti does not influence the state of alertness, therefore it does not affect the ability to drive and use machines.
Foille Insetti contains cetyl alcohol, stearyl alcohol and lanolin
This medicine contains cetyl alcohol, stearyl alcohol and lanolin which may cause local skin reactions (such as contact dermatitis, an inflammatory disease).
Dosage and method of use How to use Foille insects: Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children over 2 years of age: apply a thin layer of cream on the affected area, massaging lightly, twice a day.
Warning: 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, please contact your doctor.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Overdose What to do if you have taken an overdose of Foille Insects
In case of accidental ingestion / intake of an excessive dose of Foille Insetti, notify your doctor immediately or contact the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Foille Insects
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), local sensitization reactions (allergy) may occur.
In general, the application on the skin of medicines similar to this (corticosteroids) does not cause obvious disturbances due to absorption into the body (systemic absorption). When applied to large surfaces, or for prolonged periods of time, or to diseased skin, or in the case of an occlusive dressing (use of the medicine with a waterproof dressing), this medicine can be absorbed in sufficient quantities to cause 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)
- in patients with pheochromocytoma (a benign tumor frequently located in the adrenal gland), life-threatening pheochromocytoma crises can occur (see section 4.4).
- urticaria.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store below 25 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
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: isopropanol, cetyl alcohol, stearyl alcohol, lanolin, PEG1000 monostearate, PEG4000 monostearate, PEG6000 monostearate, bitter almond flavor and purified water.
Description of the appearance of Foille Insects and contents of the package
Foille Insetti is a cream contained in a 15 g tube.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FOILLE INSECTS 0.5% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principle: Hydrocortisone 0.5 g
Excipients: cetyl alcohol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Insect bites, itching, rashes and eczema.
04.2 Posology and method of administration
Rubbing lightly, spread the cream on the affected part in a thin layer, twice a day.
Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. The use of hydrocortisone is contraindicated in the case of viral, bacterial and fungal diseases.
04.4 Special warnings and appropriate precautions for use
FOILLE INSETTI must be used for external use only. Do not apply on mucous membranes. Avoid contact with eyes.
In children under 2 years of age, FOILLE INSETTI should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
It is a good idea to avoid prolonged use of FOILLE INSETTI, especially on large surfaces.
The use, especially if prolonged, of products for topical use can give rise to phenomena of irritation or sensitization. In this case, it is necessary to stop the treatment and consult the doctor in order to establish a suitable therapy.
If skin irritation appears, treatment must be suspended.
After a short period of treatment without appreciable results, consult your doctor.
Cetyl alcohol, present as an excipient in Foille Insetti, can cause local skin reactions (such as, for example, contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and breastfeeding
To be used under direct medical supervision.
04.7 Effects on ability to drive and use machines
Foille Insetti does not influence the state of alertness; therefore it does not affect the ability to drive or use machines.
04.8 Undesirable effects
As with all topical preparations, local sensitization reactions may occur.
In general, the topical application of corticosteroids does not produce clinical evidence of systemic absorption. When applied on large surfaces, or for prolonged periods of time, or on non-intact skin, or in the case of an occlusive dressing, hydrocortisone can be absorbed in quantity. sufficient to cause systemic effects.
04.9 Overdose
There are no known symptoms to refer to overdose of the drug.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Medicinal product category: Dermatologicals, corticosteroids, category 1; ATC code: D07AA02.
Hydrocortisone or cortisol is an active glucorticoid steroid for topical application on the skin, as it suppresses the inflammatory and allergic response, eliminating the clinical manifestations, without influencing the causes and the evolution of the pathological process that is responsible.
It also inhibits the synthesis of specific proteins with significance in chemotaxis and immunological reactions and modifies immune and macrophage functions.
05.2 Pharmacokinetic properties
Hydrocortisone is rapidly absorbed in the skin, especially in hairless areas. After topical application, only minimal quantities of the drug reach the dermal layer and, consequently, the systemic circulation; most of it remains localized in the more superficial layers of the skin. This eventuality comes to an end if a conspicuous part of the epidermis is destroyed in depth.
05.3 Preclinical safety data
Based on the results obtained from toxicity tests conducted on animals, in particular rats, a risk of fetal harm must be considered as probable.
According to the AGS, hydrocortisone is not considered carcinogenic or mutagenic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Isopropanol, cetyl alcohol, stearyl alcohol, lanolin, PEG 1000 monostearate, PEG 4000 monostearate, PEG 6000 monostearate, bitter almond flavor and purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
30 months
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
15 g tube
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / b - IT-20158 Milan (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
AIC 020051037
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
26 January 1967/1 June 2010
10.0 DATE OF REVISION OF THE TEXT
October 2014
