Package leaflet: Information for the user

SINTOTRAT 0.5% Cream

Hydrocortisone acetate
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.

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

Contents of this leaflet:

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

1. What Sintotrat is and what it is used for

Sintotrat contains the active substance hydrocortisone acetate and belongs to the class of corticosteroids for dermatological use, with anti-inflammatory and antipruritic activity.
Sintotrat is indicated for the treatment of skin disorders such as eczema, insect bites, erythema, or localized burns, and reduces itching.
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 Sintotrat

Do not use Sintotrat

if you are allergic to hydrocortisone acetate or to any of the other ingredients of this medicine (listed in section 6).
in case of viral, bacterial, or fungal infections.
for vulvar treatment if associated with vaginal discharge.

Warnings and precautions
Talk to your doctor or pharmacist before using Sintotrat.
Sintotrat is intended for external use only. The cream must not be applied directly to the mucous membranes of the eyes, but only to the surrounding areas.
Avoid prolonged applications, especially over large areas of skin.
"For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test."
Children
In children under 2 years of age, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Sintotrat
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions or incompatibilities with other commonly used medicines have ever been reported.
Pregnancy and breastfeeding
In pregnant women, this product should be administered only when clearly necessary and under direct medical supervision.
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Sintotrat contains propylene glycol, which may cause skin irritation, methyl p-hydroxybenzoate and
propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Sintotrat

Use this medicine exactly as described 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 of skin, gently massaging it in, no more than 2–3 times daily.
Do not exceed the recommended doses without medical advice.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Use only for short treatment periods.
If symptoms do not resolve within a few days, treatment should be discontinued and you should consult your doctor.
Use in children
In children under 2 years of age, this medicine should be used only when strictly necessary and under direct medical supervision.
If you use more Sintotrat than you should
In case of accidental ingestion/overdose of Sintotrat, contact your doctor immediately or go to the nearest hospital.
Cases of overdose are not known with topical use of hydrocortisone acetate at the concentration contained in Sintotrat; however, prolonged applications should nevertheless be avoided, particularly over large skin areas.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The use, especially if prolonged, of topical products may lead to local irritation or sensitization reactions; in such cases treatment must be discontinued and a doctor should be consulted in order to initiate appropriate therapy. Systemic side effects of topical corticosteroid preparations are extremely unlikely due to the low dosages used, and if they do occur, they are generally transient.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system at the website http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sintotrat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, which refers to the product in its original, unopened packaging properly stored.
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 Sintotrat contains

The active substance is hydrocortisone acetate. 100 g of cream contain 0.5 g of hydrocortisone acetate.
The other components are: polyglycolic esters of fatty acids, silicone oil 350 cP, propylene glycol, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethylenediaminetetraacetic acid, purified water.

Description of the appearance of Sintotrat and the contents of the pack
20 g cream tube.
Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Manufacturers
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)
Zeta Farmaceutici S.p.A. - Via Galvani 10 - Sandrigo (VI)
Bracco S.p.A. - Via Caduti di Marcinelle, 13 - Milano