SAMI Drug Safety Reporting Online From SAMI Drug Safety Reporting Online Form Patient Information Initials Gender * Please SelectMaleFemale Age Country Suspected Drug Details Drug Name/s* (if it is more than one drug please use comma) Name of Disease for Which Drug was Used(Indication) Batch / Lot Number Dose and Frequency Manufacturer/MarketerPlease SelectSAMI ProductHealthtek ProductAny Other Any Other DosagePlease SelectTabletsCapsuleSuspensionSyrupInjectionSachetTopicalOthers Other Start Date Stop Date Adverse Event (AE) Details Date of Onset Resolved / Improved Date Adverse Event Details * (provide diagnosis if known) Management of Events Did any of the following Occurs? Lack of EfficacyOff label UseMisuseAbuseOverdoseMedication Error (ME)ME with AEME without AEPregnancy Report Infant with AEs following Exposure from BreastfeedingOccupational Exposure with AEDrug InteractionsUnexpected BenefitsTransmission of Infectious Agents via the ProductMedical Device IncidentCounterfeit or Falsified MedicinesNone Seriousness Please SelectDeathLife threatening (Immediate Risk of Death due to an Event)Initial / Prolonged HospitalizationBirth DefectsPersistent / Significant DisabilityMedically Significant (important medical events that may jeopardize the patient and may require medical / surgical intervention to prevent the other outcome)Non Serious Death Date Cause of Death Outcome Please SelectDeathNot ResolvedResolvedResolved with SequelaeResolvingUnknown Pregnancy Exposure Last Date of Menstrual Cycle Expected Delivery Date Reporter Information Name Profession / Qualification Telephone Number * Email Address Additional Information *(provide information about your medical history, other medications or any laboratory finding/s you would think would help) Permission to contact Health Care Professional (HCP) SAMI Pharmaceuticals (Pvt.) Limited has an obligation to seek additional information from your Health Care Professional to gain additional knowledge about the adverse events, please confirm whether SAMI Pharmaceuticals (Pvt.) Limited can contact your doctor? Permission to Contact HCPPlease SelectIf “Yes”, please provide your doctor´s contact detailsNo Name of Doctor Contact Number Email Address Mailing Address If “No”, SAMI Pharmaceuticals (Pvt.) Limited will respect that and not contact your doctor but we highly suggest you to discuss any safety related concern to your prescribing physician. Please fill in the fields as accurate as possible. Fields marked with * must be filled in to submit your form to our Drug Safety Department. Note: Please note, we cannot provide medical advice on your symptoms, if you are concerned about your symptoms, or they worsen, you should contact your doctor or Health Care Professional. All personal information related to the reporting of adverse events is processed in accordance with the data protection legislation. Please learn more using the FAQs on Drug Safety for making effective reporting of adverse event. Thank you for providing the information.