TWYNSTA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

C09DB04

INN (International Name):

TELMISARTAN AND AMLODIPINE

Dosage:

80MG; 10MG

Pharmaceutical form:

TABLET

Composition:

TELMISARTAN 80MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Administration route:

ORAL

Units in package:

14/28

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0252947004; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-08-03

Summary of Product characteristics

_ _
_Product Monograph _
_ _
_TWYNSTA (telmisartan/amlodipine) _
_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TWYNSTA
®
Telmisartan / Amlodipine (as Amlodipine Besylate) Tablets
Tablet, 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg, Oral
Angiotensin II AT1 Receptor Blocker / Calcium Channel Blocker
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Initial Authorization:
AUG 11, 2011
Date of Revision:
October 4, 2022
Submission Control Number: 264045
BICL CCDS# 0275-08
Twynsta
®
is a registered trademark used under license by Boehringer Ingelheim
(Canada) Ltd.
_ _
_Product Monograph _
_ _
_TWYNSTA (telmisartan/amlodipine) _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
10/2022
7 WARNINGS AND PRECAUTIONS
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......