Given the available data on interactions with duloxetine, childhood intoxication, and Brugada syndrome, PRAC considers the causal relationship between amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide and these risks at least a reasonable possibility. PRAC concluded that information about products containing amitriptyline, amitriptyline/amitriptylinoxide, and amitriptylinoxide should be changed accordingly.

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