TEVA-LISINOPRIL/HCTZ (TYPE Z) TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISINOPRIL (LISINOPRIL DIHYDRATE); HYDROCHLOROTHIAZIDE

Available from:

TEVA CANADA LIMITED

ATC code:

C09BA03

INN (International Name):

LISINOPRIL AND DIURETICS

Dosage:

10MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL (LISINOPRIL DIHYDRATE) 10MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0222417003; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-12-08

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-LISINOPRIL/HCTZ (TYPE Z)
Lisinopril and Hydrochlorothiazide Tablets
Tablets, 10 mg / 12.5 mg, 20 mg / 12.5 mg and 20 mg / 25 mg, Oral
Angiotensin Converting Enzyme Inhibitor / Diuretic (C09BA03)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control Number: 262161
Date of Initial Authorization:
November 21, 2007
Date of Revision:
August 11, 2022
TEVA-LISINOPRIL/HCTZ (TYPE Z) Page 2 of 63
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions – Ophthalmologic
08/2022
7 Warnings and Precautions – Carcinogenesis and Mutagenesis
08/2022
7 Warnings and Precautions – Skin
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS............................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
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