What is pharmacovigilance?
Pharmacovigilance is that set of activities that aim to continuously collect all the safety data and information available on the use of medicinal products. It therefore takes care of identifying, evaluating, understanding and preventing adverse effects or any problem related to the use of medicines.

What is an adverse event? What is an adverse reaction?
An adverse event is any unfavourable episode that occurs after the administration of a drug, but which is not necessarily caused by taking the drug.

An adverse reaction, on the other hand, is a noxious and unintentional response to a drug for which a causal relationship with the drug taken can be established.

To distinguish an adverse event or an adverse reaction, it must be assessed whether it is possible to trace a cause related to the medicinal product. It is not sufficient that the event occurred within a short time of taking the drug.

What to do in case of an adverse event?
You can report an adverse event:

– in general, talking to your doctor or pharmacist

– in Italy, following the instructions reported on the AIFA (Italian Medicines Agency) at the following link:
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse

– resident in an EU country: following the instructions indicated on the website: https://www.adrreports.eu/en/index.html  

– resident in a non-EU country: checking the websites of the national regulatory agencies / ministries of health

You can also report an alleged adverse reaction directly to Laboratorio Farmaceutico SIT or to one of the companies of the group:

– calling n. +39 0677209020

– sending an e-mail to pharmacovigilance@sit-farmaceutici.com

– filling out the form: