Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

As with related compounds, alcoholic beverages should be avoided during PROTOCIDE therapy because of the possibility of a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia). Alcohol should be avoided until 72 hours after discontinuing PROTOCIDE .

Drugs of similar chemical structure have also produced various neurological disturbances such as dizziness, vertigo, incoordination and ataxia. If during therapy with PROTOCIDE abnormal neurological signs develop, therapy should be discontinued.

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although carcinogenicity data is not available for tinidazole, the two drugs are structurally related and therefore there is a potential for similar biologic effects. Mutagenicity results with tinidazole were mixed (positive and negative) (see section 5.3). The use of tinidazole for longer treatment than usually required should be carefully considered.

Effects on Driving

4.7 Effects on ability to drive and use machines

No special precautions should be necessary. However, drugs of similar chemical structure, including PROTOCIDE , have been associated with various neurological disturbances such as dizziness, vertigo, ataxia, peripheral neuropathy (paraesthesia, sensory disturbances, hypoaesthesia) and rarely convulsions. If any abnormal neurological signs develop during PROTOCIDE therapy, the drug should be discontinued.