Antidepressant drugs increased the risk, compared to placebo, of suicidal thinking and behaviour (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of EXINUS PLUS or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants, compared to placebo, in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behaviour. Families and caregivers should be advised about the need for close observation and communication with the prescriber EXINUS PLUS is not approved for use in paediatric patients less than 12 years of age.

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