Country: Canada
Language: English
Source: Health Canada
OLMESARTAN MEDOXOMIL
ANGITA PHARMA INC.
C09CA08
OLMESARTAN MEDOXOMIL
20MG
TABLET
OLMESARTAN MEDOXOMIL 20MG
ORAL
100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0152496002; AHFS:
APPROVED
2018-05-22
_Pr_ _AG-OLMESARTAN_ Page 1 of 24 PRODUCT MONOGRAPH PR AG-OLMESARTAN Olmesartan Medoxomil Tablets 20 mg, and 40 mg Angiotensin II AT 1 Receptor Blocker Angita Pharma Inc. Date of Preparation: 1310 rue Nobel, May 18, 2018 Boucherville, Quebec J4B 5H3 Submission Control No.: 214735 _Pr_ _AG-OLMESARTAN_ Page 2 of 24 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION....................................................... 3 SUMMARY PRODUCT INFORMATION..................................................................... 3 INDICATIONS AND CLINICAL USE........................................................................... 3 CONTRAINDICATIONS................................................................................................ 3 WARNINGS AND PRECAUTIONS............................................................................... 4 ADVERSE REACTIONS................................................................................................. 7 DRUG INTERACTIONS................................................................................................. 10 DOSAGE AND ADMINISTRATION............................................................................. 11 OVERDOSAGE................................................................................................................ 13 ACTION AND CLINICAL PHARMACOLOGY............................................................ 13 STORAGE AND STABILITY......................................................................................... 15 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................ 15 PART II: SCIENTIFIC INFORMATION............................................................................... 16 PHARMACEUTICAL INFORMATION......................................................................... 16 CLINICAL TRIALS......................................................................................................... 16 DETAILED PHARMACOLOGY................................................................. Read the complete document