Active ingredients: Hydrocortisone (Hydrocortisone acetate)
SINTOTRAT 0.5% Cream
Why is Sintotrat used? What is it for?
Sintotrat contains the active ingredient hydrocortisone acetate and belongs to the category of cortisone for dermatological use with anti-inflammatory and anti-itching activity.
Sintotrat is indicated for the treatment of skin disorders such as eczema, insect bites, erythema or localized burns and reduces itching.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Sintotrat should not be used
Do not use Sintotrat
- if you are allergic to hydrocortisone acetate or any of the other ingredients of this medicine.
- in case of viral, bacterial and fungal diseases.
- in case of vulvar treatment if associated with vaginal discharge.
Precautions for use What you need to know before taking Sintotrat
Talk to your doctor or pharmacist before using Sintotrat.
Sintotrat is indicated for external use only. The cream should not be used directly on the mucous membrane of the eyes, but should be applied to the surrounding areas.
Avoid prolonged applications, especially on large surfaces.
"For those who practice sports:" the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests. "
Children
In children under 2 years of age, the medicine should be administered only in cases of real need and under the direct supervision of the doctor.
Interactions Which drugs or foods can modify the effect of Sintotrat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No negative interactions or incompatibility of use with other drugs commonly used in therapy have ever been described.
Warnings It is important to know that:
Pregnancy and breastfeeding
In pregnant women, the product should be administered in cases of real need and under direct medical supervision.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
It does not affect the ability to drive and use machines.
Sintotrat contains propylene glycol which can cause skin irritation, methyl phydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (possibly delayed).
Dose, Method and Time of Administration How to use Sintotrat: Posology
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 skin area, massaging lightly, no more than 2-3 times a day.
Do not exceed the prescribed dose unless recommended by your physician.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Use only for short periods of treatment.
If the symptoms do not resolve within a few days, the treatment should be stopped and the doctor consulted.
Use in children
In children under 2 years of age, the medicine should be administered only in cases of real need and under the direct supervision of the doctor.
Overdose What to do if you have taken too much Sintotrat
In case of accidental ingestion / intake of an excessive dose of Sintotrat, notify your doctor immediately or go to the nearest hospital.
Cases of overdose are not known with the local use of hydrocortisone acetate at the concentration contained in Sintrotrat; however, prolonged applications should be avoided, especially on large surfaces.
Side Effects What are the side effects of Sintotrat
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use, especially if prolonged, of products for local use can give rise to local phenomena of irritation or sensitization; in this case it is necessary to interrupt the treatment and consult the doctor in order to establish a suitable therapy. The systemic side effects of the preparations Corticosteroids for local use are extremely unlikely due to the low dosages employed and, if they occur, they are generally transient.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 / responsible. 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 that refers to the unopened, correctly stored product.
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 Sintotrat contains
- The active ingredient is hydrocortisone acetate. 100 g of cream contains 0.5 g of hydrocortisone acetate.
- The other ingredients are: polyglycolic esters of fatty acids, silicone oil 350 cP, propylene glycol, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethylenediaminetathetic acid, purified water.
What Sintotrat looks like and contents of the pack
20g cream 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
SINTOTRAT 0.5% CREAM 1 TUBE OF 20 G
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principle:
Hydrocortisone acetate 0.5 g
03.0 PHARMACEUTICAL FORM
Cream for dermatological use
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Sintotrat 0.5% cream is indicated for the symptomatic treatment of itching, eczema, insect bites, erythema or localized burns.
04.2 Posology and method of administration
For adults and children over 2 years of age:
apply a thin layer of cream on the affected skin area, massaging lightly, no more than 2-3 times a day.
Do not exceed the recommended dose
If the symptoms do not resolve within a few days, the treatment should be stopped and the doctor consulted.
04.3 Contraindications
Individual ascertained hypersensitivity to the product.
As for any other cortisone preparation for topical use, the use of Sintotrat 0.5% cream is contraindicated in the case of viral, bacterial and fungal diseases.
04.4 Special warnings and appropriate precautions for use
Sintotrat 0.5% cream is indicated for external use only. The cream is not for ophthalmological use, but should be applied in the periocular areas. Avoid prolonged applications especially on large surfaces. Not to be used in the treatment of vulvar itching if associated with vaginal discharge.
In children under two years of age, the product should be administered in cases of real need under the direct supervision of the doctor.
Keep this medicine out of the reach of children. Do not use the drug beyond the expiration date indicated on the package.
04.5 Interactions with other medicinal products and other forms of interaction
No negative interactions or incompatibility of use with other drugs commonly used in the relevant therapy have ever been identified.
04.6 Pregnancy and breastfeeding
In pregnant women, the product should be administered in cases of real need under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
The product does not compromise the ability to drive and use machines.
04.8 Undesirable effects
The use, especially if prolonged, of products for topical use can give rise to local phenomena of irritation or sensitization; in this case it is necessary to interrupt the treatment and consult the doctor in order to establish a suitable therapy. The systemic side effects of Corticosteroid preparations for topical use are extremely unlikely due to the low dosages used; in case of onset it is necessary to stop the therapy and consult your doctor or pharmacist
04.9 Overdose
Cases of overdose are not known with the topical use of hydrocortisone at the concentration contained in Sintotrat 0.5% cream; however, avoid prolonged applications, especially on large surfaces.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Sintotrat 0.5% cream contains a corticosteroid, hydrocortisone 17-acetate, commonly used in dermatology for its high anti-inflammatory and anti-itching activity.
5.1 Pharmacodynamic properties
Hydrocortisone, like the other glucocorticoids, has an anti-inflammatory and anti-allergic action, with mechanisms still not fully understood. The theory according to which hydrocortisone stabilizes some membrane enzymes and prevents the conversion of precursors to prostaglandins seems now accepted. Of great importance is the topical use of corticosteroids and therefore of hydrocortisone acetate, which has revolutionized the therapy of dermatological diseases. The 0.5% dosage has been defined "safe and effective" by the F.D.A., In O.T.C. products, indicated in the treatment of minor skin disorders, identifiable by the same patient.
05.2 Pharmacokinetic properties
Although hydrocortisone is absorbed through the skin, the blood levels reached are so low that it is unlikely that they can cause the secondary effects associated with systemic administration.
05.3 Preclinical safety data
The acute toxicity of hydrocortisone, determined orally in mice, rats, guinea pigs and cats, was found to be of relative magnitude: subcutaneously and for prolonged treatments (toxicity at three weeks), toxic effects occurred at the dose of 2.4 mg / kg.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polyglycolic esters of fatty acids, 350 cP silicone oil, propylene glycol, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethylenediaminetetraacetic acid, purified water.
06.2 Incompatibility
None
06.3 Period of validity
5 years
06.4 Special precautions for storage
None
06.5 Nature of the immediate packaging and contents of the package
Aluminum tubes coated with protective epoxy resins equipped with a special plastic cap.
20 g tube of cream
06.6 Instructions for use and handling
None
07.0 MARKETING AUTHORIZATION HOLDER
BRACCO S.p.A.
Via E.Folli, 50 - 20134 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC 025753017 - October 1987
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 1987 / June 2010
10.0 DATE OF REVISION OF THE TEXT
June 2010
