Medicinal safety
Adverse drug reaction reporting forms
Guidelines for reporting an adverse drug reaction:
AN ADVERSE DRUG REACTION is any unwanted and unintended response to a medicinal product. The accompanying leaflet, contains important safety information, with which it is necessary for the user to familiarize himself before use. The section “Adverse drug reactions” contains a description of those already observed and advice on what to do, if the same occur.
If you experience any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
The personal data of the reporter/patient is protected and treated in accordance with the Delegated Regulation for the Protection of Personal Data.
To report an adverse event, related to a medicinal product , whose license holder is Alumed OOD, please contact us via:
Completing and submitting the appropriate form FOR REPORTING ADVERSE DRUG REACTIONS
Phone for 24 hourly connection: +359 895553393
Email:safety@alumed.bg
You can also report adverse reactions directly through the national reporting system to the Bulgarian Medicines Agency – № 8, he is. Damian Gruev, postal code 1303, Sofia, telephone +35928903417, web: www.bda.bg
non-medical persons
The information, which you will provide us, is extremely important for the detection of unknown adverse reactions to medicinal products, authorized for use on the territory of the Republic of Bulgaria. We will need your contact details for feedback purposes, to confirm receipt of the message, if we need to request additional information, as well as to inform you about the measures taken. We assure you, that the personal data of the reporter/patient is treated in accordance with the Personal Data Protection Act.
medical persons
We remind medical professionals, that they are obliged according to the requirements of ZLPHM to notify the Executive Agency for Medicines (IAL) and to the MAH any suspected serious or unexpected adverse drug reaction, regardless of whether or not the medicinal product is used in accordance with the approved Summary of Product Characteristics.