APO-RAMIPRIL/HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROCHLOROTHIAZIDE; RAMIPRIL

Available from:

APOTEX INC

ATC code:

C09BA05

INN (International Name):

RAMIPRIL AND DIURETICS

Dosage:

12.5MG; 2.5MG

Pharmaceutical form:

TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5MG; RAMIPRIL 2.5MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0251649002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-07-02

Summary of Product characteristics

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_APO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RAMIPRIL/HCTZ
Ramipril and Hydrochlorothiazide Tablets
Tablets, 2.5 /12.5 mg, 5 /12.5 mg, 10 /12.5 mg, 5 /25 mg, 10 /25 mg,
oral
Angiotensin converting enzyme inhibitor plus diuretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario M9L 1T9
Date of Initial Authorization:
JUL 02, 2010
Date of Revision:
APR 28, 2022
Submission Control Number: 258626
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_APO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................................
4
1
INDICATIONS..........................................................................................................................
4
1.1
Pediatrics........................................................................................................................
4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND
ADMINISTRATION...............................................................................................
6
4.1 Dosing
Considerations..................................................................................