XATRAL TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

G04CA01

INN (International Name):

ALFUZOSIN

Dosage:

10MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

ALFUZOSIN HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

Selective Alfa-1-Adrenergic Blocking Agents

Product summary:

Active ingredient group (AIG) number: 0146806001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-03-20

Summary of Product characteristics

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_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
XATRAL
®
Alfuzosin Hydrochloride
Prolonged-Release Tablets
10 mg
Pharmaceutical standard: Professed
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION
(AUR)
ATC Code: G04CA01
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
January 2, 2019
Submission Control No.: 221120
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_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
6
DRUG INTERACTIONS
........................................................................................................
11
DOSAGE AND ADMINISTRATION
....................................................................................
14
OVERDOSAGE
......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 16
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 23
PART II: SCIENTIFIC INFORMATION
........................................