Report side effects

Reporting Side Effects from Medicines

Any side effects that occur during the course of treatment with medication must be reported promptly to your primary care healthcare professional or pharmacist, or directly to the referring healthcare facility.

In accordance with the current regulations in Italy, physicians and other healthcare professionals must submit reports of suspected adverse events to the pharmacovigilance officer of their healthcare facility.

If you wish to report side effects related to Bayer drugs, please follow the instructions on the Italian Medicines Agency (AIFA) website:

https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse

You can also call Bayer S.p.A. at:

Telephone (Switchboard): 02.3978. 1

Reporting Side Effects from Cosmetics

If you wish to report side effects that are potentially due to the use of a cosmetic product, report them to your healthcare professional or pharmacist, or to the Ministry of Health using the National Reporting Form that can be downloaded from the website:

http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=3846&area=cosmetici&menu=vigilanza

You can also call Bayer S.p.A. at:

Telephone (Switchboard): 02.3978. 1

Reporting Side Effects from Medicinal Plant Products and Dietary Supplements

If you want to report side effects from medicinal plant products or dietary supplements, report them to your healthcare professional or pharmacist, or to the Ministry of Health using the National Reporting Form that can be downloaded from the website:

http://www.epicentro.iss.it/focus/erbe/fitosorveglianza.asp

You can also call Bayer S.p.A. at:

Telephone (Switchboard): 02.3978. 1

Reporting Accidents and Near Misses Possibly Related to Medical Devices

Public or private healthcare professionals who in the course of their activities identify an accident involving a medical device are required to notify the Ministry of Health, within the time limits and in the manner established by the regulations, as set out on the following website:

http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=26&area=dispositivi-medici&menu=vigilanza

The report must also be sent to the manufacturer using the following contact details:

Telephone (Switchboard): 02.3978. 1

Fax (Pharmacovigilance): 02.3978.4486

Complaints Relating to the Quality of Bayer Products

For any complaints regarding the quality of Bayer products for human use, please use the following contact details:

Telephone (Switchboard): 02.3978. 1

Fax (Quality Assurance): 02.3978.4914

Reporting Side Effects from Veterinary Products

For veterinary medicines, veterinarians and pharmacists are required by law to report to the Ministry of Health and Regional Centers.

Reporting side effects to the company that holds the Marketing Authorization for the drug at the same time is a valuable contribution to the company's ongoing monitoring of the safety of its drugs.

If you would like to report adverse events related to Bayer veterinary medicines to the Ministry of Health, use this link:

http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=MDV&idAmb=FMV&idSrv=PSK&flag=P

However, to contact Bayer Animal Health Pharmacovigilance, including in relation to products other than veterinary medicines, and for any complaints related to product quality, please contact the Bayer switchboard at 02.3978.1, which will transfer you to the appropriate point of contact.

In accordance with the current regulations in Italy, physicians and other healthcare professionals must submit reports of suspected adverse events to the pharmacovigilance officer of their healthcare facility.

If you wish to report side effects related to Bayer drugs, please follow the instructions on the Italian Medicines Agency (AIFA) website:

https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse

You can also call Bayer S.p.A. at:

Telephone (Switchboard): 02.3978. 1



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