RISPERIDONE TABLET, FILM-COATED

SECTION 2: Hazards identification

Product definition

This product is supplied as odorless, round, dark yellow (0.25 mg), red-brown (0.5 mg), white to off-white (1 mg), orange (2 mg), yellow (3 mg) or green (4 mg) tablets. Health Hazards: In the workplace, exposure via inhalation and skin contact may cause irritation. Dusts from tablets can cause mechanical irritation to the eyes. Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported include somnolence, increased appetite, fatigue, insomnia, sedation, parkinsonism, unpleasant sensations of inner restlessness, vomiting, cough, constipation, nasopharyngitis, drooling, runny nose, dry mouth, abdominal pain upper, dizziness, nausea, anxiety, headache, nasal congestion, inflammation of nasal mucous membranes, tremor, and rash. Therapeutic use may cause adverse effects on the metabolic, central nervous and cardiovascular systems, and can cause blood disorders, which can be severe or fatal. In susceptible persons, therapeutic use may cause a severe reaction (Neuroleptic Malignant Syndrome [NMS]) accompanied with fever and body rigidity, renal failure and other serious symptoms, which can also be fatal. In certain individuals, long-term use may cause a condition that causes involuntary movements and can be permanent. Severe anaphylactic reactions have been reported. Some human evidence indicates possible harm to fetus during pregnancy. Limited evidence of adverse effect on fertility, based on animal information. Breast-feeding during therapeutic use may harm to infants. These effects may be possible as a result of workplace exposure. See Section 11 (Toxicological Information) for information on other potential health hazards known from therapeutic use. 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 aluminum, carbon, iron, magnesium, titanium, silicon, sodium and nitrogen oxides and hydrogen fluoride). Reactivity Hazards This product is not reactive.

Environmental hazards

The active ingredient is toxic to aquatic organisms and can cause long term damage in an aquatic environment. 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.