APO-TRAMADOL/ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-09-2022
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
APOTEX INC
ATC code:
N02AJ13
INN (International Name):
TRAMADOL AND PARACETAMOL
Dosage:
325MG; 37.5MG
Pharmaceutical form:
TABLET
Composition:
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0250601001; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-11-06
Summary of Product characteristics
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
APO-TRAMADOL/ACET
Tramadol Hydrochloride/Acetaminophen Tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
September 14, 2022
SUBMISSION CONTROL NUMBER: 266547
_Page 2 of 70 _
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
..............................................................................................
18
DRUG INTERACTIONS
.............................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE..........................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 32
STORAGE AND STABILITY
.......................................................................................
40
SPECIAL HANDLING INSTRUCTIONS
....................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
........................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
.......................
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