ALEMBIC-TELMISARTAN/HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROCHLOROTHIAZIDE; TELMISARTAN

Available from:

ALEMBIC PHARMACEUTICALS LIMITED

ATC code:

C09DA07

INN (International Name):

TELMISARTAN AND DIURETICS

Dosage:

25MG; 80MG

Pharmaceutical form:

TABLET

Composition:

HYDROCHLOROTHIAZIDE 25MG; TELMISARTAN 80MG

Administration route:

ORAL

Units in package:

(10X10)/30/1000

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0244783002; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-08-09

Summary of Product characteristics

_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 1 of 57 _
_ _
PRODUCT MONOGRAPH
PR
ALEMBIC-TELMISARTAN/HCTZ
Telmisartan and Hydrochlorothiazide Tablets, USP
80 mg/12.5 mg
80 mg/25 mg
(telmisartan/hydrochlorothiazide)
Angiotensin II AT
1
Receptor Blocker/Diuretic
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road,
Vadodara 390003,
Gujarat, India
IMPORTED AND DISTRIBUTED BY:
Alembic Pharmaceuticals Canada Ltd.
225 Gibraltar Road, Unit 5
Vaughan, Ontario
L4H 4P9, Canada
CONTROL NUMBER:
256615
DATE OF PREPARATION:
March 30, 2022
_ _
_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 2 of 57_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................