AG-OLMESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-05-2018
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Active ingredient:
OLMESARTAN MEDOXOMIL
Available from:
ANGITA PHARMA 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:
2018-05-22
Summary of Product characteristics
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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
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_AG-OLMESARTAN_
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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.................................................................
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