UROMAX TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-10-2013
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Active ingredient:
OXYBUTYNIN CHLORIDE
Available from:
PURDUE PHARMA
ATC code:
G04BD04
INN (International Name):
OXYBUTYNIN
Dosage:
15MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
OXYBUTYNIN CHLORIDE 15MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
Antimuscarinics
Product summary:
Active ingredient group (AIG) number: 0114692005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2013-08-01
Summary of Product characteristics
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_Page 1 of 26_
PRODUCT MONOGRAPH
Pr
UROMAX
®
Oxybutynin Chloride
Controlled Release Tablets – 5, 10 and 15 mg
Anticholinergic-Antispasmodic
ATC: G04BD04
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
DATE OF REVISION:
October 16, 2013
SUBMISSION CONTROL NO: 167196
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_Page 2 of 26_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.................................................
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