Phenytoin Tablets (Greenstone LLC)

SECTION 2: Hazards identification

Appearance: Yellow chewable tablet

Signal word

WARNING

Hazard statements

Suspected of causing cancer. May cause harm to the unborn child.

Additional information

Short Term: Active ingredient may be harmful if swallowed. Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood and blood forming organs gastrointestinal system and liver Known Clinical Effects: The most common adverse effects observed with clinical use of phenytoin are lack of appetite, headache, dizziness, transient nervousness, ataxia, slurred speech, decreased coordination, mental confusion, insomnia, and GI disturbances (nausea, vomiting, and constipation). IV administration has been associated with hypotension and CNS depression. Mild hypersensitivity reactions (skin rashes) are common. Effects on blood- forming organs and the liver have occurred rarely. Other less common effects include swollen lymph nodes, sore mouth, and symptoms of dependence/withdrawal. There is an unconfirmed association between the use of anticonvulsants during pregnancy and an increased risk of birth defects. This material has been shown to be secreted in low concentrations in human breast milk. EU Indication of danger: Carcinogenic: Category 3 Toxic to Reproduction: Category 2 EU Hazard Symbols: EU Risk Phrases: R40 - Limited evidence of a carcinogenic effect R61 - May cause harm to the unborn child. Australian Hazard Classification

Hazardous Ingredients

Non-Dangerous Goods (NOHSC): Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.