VAN-TELMISARTAN-HCTZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-11-2014
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Active ingredient:
TELMISARTAN; HYDROCHLOROTHIAZIDE
Available from:
VANC PHARMACEUTICALS INC
ATC code:
C09DA07
INN (International Name):
TELMISARTAN AND DIURETICS
Dosage:
80MG; 25MG
Pharmaceutical form:
TABLET
Composition:
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 25MG
Administration route:
ORAL
Units in package:
28/30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0244783002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2019-07-31
Summary of Product characteristics
_VAN-Telmisartan-HCTZ Product Monograph _
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_ Page 1 of 53_
PRODUCT MONOGRAPH
Pr
VAN-TELMISARTAN-HCTZ
Telmisartan / Hydrochlorothiazide Tablets
80 mg/12.5 mg and 80 mg/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker/Diuretic
MANUFACTURER AND DISTRIBUTOR:
Vanc Pharmaceuticals Inc.
Building 152, 11782 River Road
Richmond, BC V6X 1Z7
www.vancpharm.com
Date of Preparation:
November 7, 2014
Submission Control No: 179134
_VAN-Telmisartan-HCTZ Product Monograph _
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_ Page 2 of 53_
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
...............................................................................................
11
DRUG INTERACTIONS
................................................................................................
21
DOSAGE AND ADMINISTRATION
...........................................................................
25
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND STABILITY
.......................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 34
PART II: SCIENTIFIC INFORMATION
.......................................................................
35
PHARMACEUTICAL INFORMATION
.....................................................................
35
CLINICAL TRIALS
.......................
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