Transcription of PRODUCT MONOGRAPH - Sanofi
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Page 1 of 38 PRODUCT MONOGRAPH PrGLUCOPHAGE Metformin Hydrochloride Tablets Manufacturer s standard 500 mg, 850 mg Oral Antihyperglycemic Agent Registered trade mark of Merck Sant . Used under licence Sanofi -aventis Canada Inc. 2905 Place Laval (Qu bec) H7V 0A3 Date de r vision : March 02, 2018 Submission Control No.: 211582 s-a Version dated March 2, 2018 Page 2 of 38 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .. 3 SUMMARY PRODUCT INFORMATION .. 3 INDICATIONS AND CLINICAL USE .. 3 WARNINGS AND PRECAUTIONS .. 5 ADVERSE REACTIONS .. 12 DRUG INTERACTIONS .. 15 DOSAGE AND ADMINISTRATION .. 17 OVERDOSAGE .. 19 ACTION AND CLINICAL PHARMACOLOGY.
Serious Warnings and Precautions Lactic acidosis is a rare, but serious, metabolic complication that occurs due to metformin accumulation during treatment with GLUCOPHAGE (see Endocrine and Metabolism, Lactic Acidosis section below). Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking GLUCOPHAGE, since alcohol intake potentiates the …
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