PRZ-OLMESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-09-2020
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Active ingredient:
OLMESARTAN MEDOXOMIL
Available from:
PHARMARIS CANADA INC
ATC code:
C09CA08
INN (International Name):
OLMESARTAN MEDOXOMIL
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
OLMESARTAN MEDOXOMIL 40MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0152496003; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-09-16
Summary of Product characteristics
_ _
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_Page 1 of 25 _
PRODUCT MONOGRAPH
PR
PRZ-OLMESARTAN
Olmesartan Medoxomil Tablets, USP
20 mg, and 40 mg
Angiotensin II AT
1
Receptor Blocker
Pharmaris Canada Inc.
8310-130
th
Street, Suite 102,
Surrey, British Columbia,
Canada V3W 8J9
Date of Approval: September 14,
2020
Submission Control No: 226771
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_Page 2 of 25 _
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
..............................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND STABILITY
..........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
................................................................................
17
PHARMACEUTICAL INFORMATION
..........................................................................
17
CLINICAL TRIALS
..........................................................................................................
18
DETAILED PHARMACOLOGY
..........
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