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PRODUCT MONOGRAPH - Sanofi

Page 1 of 36 PRODUCT MONOGRAPH PrIMOVANE (zopiclone) Tablets, mg and mg Hypnotic and Sedative Sanofi -aventis Canada Inc. 2905 Place Louis Laval, Quebec H7V 0A3 Date of Revision: May 8, 2017 Submission Control No.: 202617 s-a version dated May 8, 2017 Page 2 of 36 NAME OF DRUG PrIMOVANE (zopiclone) Tablets, mg and mg Hypnotic and Sedative WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of zopiclone and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS, Risks from concomitant use of opioids and benzodiazepines). Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Page 1 of 37 . PRODUCT MONOGRAPH . PrIMOVANE® (zopiclone) Tablets, 5.0 mg and 7.5 mg . Hypnotic and Sedative. sanofi-aventis Canada Inc. 2905 Place Louis R.-Renaud

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