MIRTAZAPINE TABLET MIRTAZAPINE ORALLY DISINTEGRATING TABLET

SECTION 2: Hazards identification

Product definition

This product is supplied as tablets which are round and off-white (15, 30 or 45 mg), or round and yellow (15mg), red-brown (30 mg) and white to off-white (30 mg). The Film Coated Tablets are odorless; the Orally Disintegrating Tablets (ODT) have an orange odor and flavor. Health Hazards: In the workplace, exposure via inhalation and skin contact may cause irritation. Dusts from tablets can cause mechanical irritation to the eyes. Non-therapeutic ingestion may be harmful. In therapeutic use, the most common adverse effects reported include constipation, weight gain, dizziness, nausea, increased appetite, dry mouth, somnolence, dizziness, peripheral edema, disturbance in thinking, serum triglyceride increase, and lack or loss of strength and energy, weakness. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported (see

TOXICOLOGICAL INFORMATION

for more information on this syndrome. Therapeutic use can cause other serious central nervous system effects, adverse effects on cardiovascular and blood systems. May cause harm to the fetus during pregnancy, based on animal data. Limited evidence of carcinogenic potential, based on animal data. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This product requires substantial pre-heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including carbon, magnesium, silicon, titanium and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

Release to the environment may have adverse effect. Emergency Recommendations Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.