APO-CETIRIZINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-12-2019
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Active ingredient:
CETIRIZINE HYDROCHLORIDE
Available from:
APOTEX INC
ATC code:
R06AE07
INN (International Name):
CETIRIZINE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
CETIRIZINE HYDROCHLORIDE 5MG
Administration route:
ORAL
Units in package:
15/30
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0122686002; AHFS:
Authorization status:
APPROVED
Authorization date:
1999-09-28
Summary of Product characteristics
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_Page 1 of 36_
PRODUCT MONOGRAPH
APO-CETIRIZINE
Cetirizine Hydrochloride Tablets
Apotex Standard
5 mg and 10 mg
Histamine H
1
Receptor Antagonist
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
December 02, 2019
Submission Control No: 231982
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_Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
.........................................................
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