METRONIDAZOLE CAPSULES and TABLETS

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC) 1272/2008 LABELING AND CLASSIFICATION: According to Article 1, item 5 (a) of CLP Regulation (EC) 1272/2008, medicinal products in the finished state for human use, as defined in 2001/83/EC, are excepted from classification and other criteria of 1272/2008. EU LABELING/CLASSIFICATION: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. EMERGENCY OVERVIEW

Product definition

This product is supplied as capsules that are opaque light green and white round and oval tablets. Health Hazards: In the workplace, exposure via inhalation and skin contact may cause irritation. Eye contact with drug product can cause mechanical irritation. Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported are nausea, headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, and abdominal cramping, sharp, metallic taste, overgrowth of Candida. Constipation has also been reported. Rare cases of pancreatitis have been reported. May cause adverse effects on neurological, cardiovascular system, Prolonged therapeutic use may cause super-infections. Use of alcohol while taking Metronidazole can cause an accumulation of systemic acetaldehyde, which can lead to serious effects or be fatal. Animal studies indicate significant carcinogenic potential. Limited evidence of mutagenic effects, 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, iron, magnesium, sodium, silicon, titanium and nitrogen oxides). Reactivity Hazards: This product is not reactive. Environmental Hazards: This product contains a compound that can cause long-term harm to aquatic organisms. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.