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Form for reporting an adverse drug reaction
How to fill out the form

Do not hesitate to send a message even when you do not have all data required in the form on your disposal!

This document is confidential! The information from your message is managed under strict confidentiality. The identity of the patient is never disclosed.

Please report all adverse drug reactions that occurred during treatment with Sopharma products using this form.

We will accept all messages sent by doctors, dental doctors, pharmacists and other health professionals with gratitude. Patients that believe they have experienced adverse drug reactions should contact their doctor.

Information about adverse drug reactions can be also reported to:

Tel.: (02) 817 74 13
Fax: (02) 974 37 59
Email: safety@sopharma.bg
Data about the patient:
Sex:
Date of birth:
Month:
Year:
Age:

Information on the suspect medicine
Suspect medicine 1 (trade name):
  *
Pharmaceutical form:
Dose, frequency and route of administration:

Start of treatment
Day:
Month:
Year:

End of treatment
Day:
Month:
Year:
Indications (reason for use):
Was administration of the suspect medicine discontinued?:
Did the patient use the suspect medicine before:
Suspect medicine 2 (trade name):
Pharmaceutical form:
Dose, frequency and route of administration:

Start of treatment
Day:
Month:
Year:

Start of treatment
Day:
Month:
Year:
Indications (reason for use):
Was administration of the suspect medicine discontinued?:
Did the patient use the suspect medicine before:

Concomitant medicines administered at the same time
Medicinal product:
Pharmaceutical form:
Dose, frequency and route of administration:
Indication for use:

Medicinal product 2:
Pharmaceutical form 2:
Dose, frequency and route of administration 2:
Indication for use 2:
Medicinal product 3:
Pharmaceutical form 3:
Dose, frequency and route of administration 3:
Indication for use 3:

Adverse drug reaction
Indication for use 3:

Start date
Day:
Month:
Year:

End date
Day:
Month:
Year:
# Outcome from the adverse reaction:
# Relationship between the suspect drug administration and the adverse reaction:
Additional information ( concomitant diseases, allergies, tests):

Did the adverse reaction cause:
Hospitalization or prolongation of hospitalization?:
Life-threatening condition?:
Persistant or significant disability?:
Surgical or medical intervention to prevent any of the above consequences?:
Congenital anomaly or birth defect?:
Did the patient die?:

Information about the person reporting the adverse reaction
Health professional:
  *
Name and surname:
Address:
Profession:
Contact phone number:
Email:

Sent message to IAL:
* Required field