ACT TELMISARTAN/HCT TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-05-2017
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Active ingredient:
TELMISARTAN; HYDROCHLOROTHIAZIDE
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
C09DA07
INN (International Name):
TELMISARTAN AND DIURETICS
Dosage:
80MG; 12.5MG
Pharmaceutical form:
TABLET
Composition:
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0244783001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-04-30
Summary of Product characteristics
_ _
_ACT TELMISARTAN/HCT Product Monograph _
_Page 1 of 52_
PRODUCT MONOGRAPH
PR
ACT
TELMISARTAN/HCT
Telmisartan/Hydrochlorothiazide Tablets
80/12.5 mg and 80/25 mg
Angiotensin II AT
1
Receptor Blocker/Diuretic
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
April 26, 2017
Submission Control No: 204813
_ _
_ACT TELMISARTAN/HCT Product Monograph _
_Page 2 of 52_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 34
PART II: SCIENTIFIC INFORMATION
..............................................................................
35
PHARMACEUTICAL INFORMATION
.........................................................................
35
CLINICAL TRIALS
.....................................................................
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