ALFUZOSIN TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-08-2017
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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
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:
CANCELLED POST MARKET
Authorization date:
2018-11-30
Summary of Product characteristics
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
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
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision: August 11, 2017
Submission Control No.: 208229
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
6
DRUG INTERACTIONS
........................................................................................................
11
DOSAGE AND ADMINISTRATION
....................................................................................
13
OVERDOSAGE
......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 14
STORAGE AND
STABILITY................................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 19
PART II: SCIENTIFIC INFORMATION
...........................................
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