SANDOZ ALFUZOSIN TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

SANDOZ CANADA INCORPORATED

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:

2008-07-08

Summary of Product characteristics

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_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr SANDOZ ALFUZOSIN
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
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision:
April 3, 2019
Submission Control No.: 225472
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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
........................................................................................................
12
DOSAGE AND ADMINISTRATION
....................................................................................
15
OVERDOSAGE
......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 16
STORAGE AND
STABILITY................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................