Posted on February 12, 2019February 13, 2019 by OnlineSPHAdverse Drug Reactions Reporting Form Please, use this form if you wish to report suspected adverse drug reactions involving Sopharma medicinal products. The submitted information is of major importance for the detection of unknown adverse reactions to our medicinal products. Please, do not hesitate to send a report even if you do not have all required data to fill out the form! Your contact information will be used in the following cases/situations: if we need to ask you for further information; to confirm that we received the report; to inform you about the measures taken; for feedback. We assure you that the reporter’s/patient’s personal data will be treated in compliance with the Personal Data Protection Act. Address: Sopharma AD, Drug Safety Department 5 Lachezar Stanchev Street, 1797, Sofia, Bulgaria Telephone: +359 700 47474; +359 800 20222; E-mail: safety@sopharma.bg Data about the person providing the information Medical specialist? * Yes No Name: * Work address: Telephone number: * Email: Data about the patient Full name/Initials: * Sex: * Male Female Age: Suspected medication Drug name: * Pharmaceutical form/unit dose: Batch number of the medicinal product: Daily dose: Treatment onset: Treatment end: Routе of administration: Indications/reason for taking the medicine: Did the patient use the suspected drug before? Yes No Unknown Was the suspected drug discontinued? Yes No Reduced drug dosage Did you take any measures to treat the reaction? Yes No Unknown Description of the measures (if taken) Add suspected medicine Remove Adverse drug reaction Description of the adverse drug reaction: * Start date: Stop date: Outcome: Recovered Recovering with sequelae Improvement Worsening No change Lethal outcome Unknown Causal link: Certain Probable Possible Improbable Conditional Unclassifiable Did the adverse reaction disappear after the drug was discontinued? Yes No Unknown Did the adverse reaction reappear after the drug re-administration? Yes No Unknown Did the adverse reaction lead to: Hospitalization or prolongation of patient’s hospital stay? Life-threatening condition? Congenital anomaly or birth defect? Permanent and significant disability? Significant medical events, such as surgical or another intervention, in order to prevent the outcomes, listed above? Death? If you give us permission to seek further information on this case from your attending physician, please specify his/her contact details. Add adverse drug reaction Remove Additional information: (treatment details, diagnostic procedures, consequences, concomitant diseases, pregnancy, abuse, allergies, medical history etc.) * Check here to indicate that you have read and agree to the terms of Sopharma AD GDPR compliant policy reCAPTCHA Send