Summary of the risk management plan for Melatonin Orifarm

VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Symptoms when stopping venlafaxine discontinuation symptoms or withdrawal syndrome

VI.2.4 Summary of safety concerns Important identified risks: Risk What is known Preventability Nervous system disorders • Extrapyramidal symptoms inability to initiate movement,

Summary of safety concerns Important identified risks Second primary malignancies Serious infection due to neutropenia Teratogenicity Important potential risks Cardiac arrhythmias

Table 8: Summary of Safety Concerns List of important risks and missing information Important identified risks x Drug-induced liver injury DILI x Photosensitivity reaction and rash

on the long-term use of the medicine/use in special patient populations etc.; Table 7 Part VI: Summary of safety concerns List of important risks and missing information Important

List of important risks and missing information Important identified risks Electrocardiogram QT prolonged Important potential risks None Missing information Use during pregnancy and

Part VI: Summary of the risk management plan by product VI.1 Elements for summary tables in the EPAR VI.1.1 Summary table of Safety concerns Summary of safety concerns Important

List of important risks and missing information Summary of safety concerns Important identified risks •Sexual adverse events altered [decreased] libido, impotence, ejaculation