Remeron Patient, Information, Instructions - Mirtazapine

Remeron Patient, Information, Instructions - Mirtazapine

PATIENT INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe REMERON^® (mirtazapine) Tablets:

Agranulocytosis

Patients who are to receive REMERON^® should be warned about the risk of developing agranulocytosis. Patients should be advised to contact their physician if they experience any indication of infection such as fever, chills, sore throat, mucous membrane ulceration or other possible signs of infection. Particular attention should be paid to any flu-like complaints or other symptoms that might suggest infection.

Clinical Worsening and Suicide Risk Patients and their families should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression, and suicidal ideation, especially early during antidepressant treatment. Such symptoms should be reported to the patient’s physician, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Interference with Cognitive and Motor Performance

REMERON^® may impair judgement, thinking, and particularly, motor skills, because of its prominent sedative effect. The drowsiness associated with mirtazapine use may impair a patient’s ability to drive, use machines or perform tasks that require alertness. Thus, patients should be cautioned about engaging in hazardous activities until they are reasonably certain that REMERON^® therapy does not adversely affect their ability to engage in such activities.

Completing Course of Therapy

While patients may notice improvement with REMERON^® therapy in 1–4 weeks, they should be advised to continue therapy as directed.

Concomitant Medication

Patients should be advised to inform their physician if they are taking, or intend to take, any prescription or over-the-counter drugs since there is a potential for REMERON^® to interact with other drugs.

Alcohol

The impairment of cognitive and motor skills produced by REMERON^® has been shown to be additive with those produced by alcohol. Accordingly, patients should be advised to avoid alcohol while taking mirtazapine.

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during REMERON^® therapy.

Nursing

Patients should be advised to notify their physician if they are breast-feeding an infant.