MED-OLMESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-05-2017
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Active ingredient:
OLMESARTAN MEDOXOMIL
Available from:
GENERIC MEDICAL PARTNERS INC
ATC code:
C09CA08
INN (International Name):
OLMESARTAN MEDOXOMIL
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
OLMESARTAN MEDOXOMIL 20MG
Administration route:
ORAL
Units in package:
2X14/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0152496002; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-05-01
Summary of Product characteristics
_Page 1 of 27_
PRODUCT MONOGRAPH
PR
MED-OLMESARTAN
Olmesartan Medoxomil Tablets
20 mg, and 40 mg olmesartan medoxomil,
Angiotensin II AT
1
Receptor
Blocker
GENERIC MEDICAL PARTNERS INC.
251 Consumers Road, Suite 1200
Toronto, Ontario
M2J 4R3
Date of Revision:
APRIL 24, 2017
Submission Control No: 178734, 204768
_Page 2 of 27_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
...................................................................................................
10
DOSAGE AND ADMINISTRATION
...............................................................................
12
OVERDOSAGE
.................................................................................................................
14
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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