RAMIPRIL-HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Available from:

SANIS HEALTH INC

ATC code:

C09BA05

INN (International Name):

RAMIPRIL AND DIURETICS

Dosage:

10.0MG; 25.0MG

Pharmaceutical form:

TABLET

Composition:

RAMIPRIL 10.0MG; HYDROCHLOROTHIAZIDE 25.0MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0251649005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-07-31

Summary of Product characteristics

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_RAMIPRIL-HCTZ Product Monograph _
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_Page 1 of 53 _
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PRODUCT MONOGRAPH
PR
RAMIPRIL-HCTZ
Ramipril and Hydrochlorothiazide Tablets
Tablets
5 mg ramipril/12.5 mg hydrochlorothiazide
10 mg ramipril/12.5 mg hydrochlorothiazide
5 mg ramipril/25 mg hydrochlorothiazide
10 mg ramipril/25 mg hydrochlorothiazide
Angiotensin converting enzyme inhibitor plus diuretic
SANIS HEALTH INC.
Date of Revision:
333 Champlain Drive, Suite 102
July 28, 2014
Dieppe, New Brunswick E1A 1P2
Submission Control No.: 175310
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_RAMIPRIL-HCTZ Product Monograph _
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_Page 2 of 53 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
................................................................................32
PHARMACEUTICAL INFORMATION
........