TRAMADOL-ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-12-2018
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
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:
CANCELLED POST MARKET
Authorization date:
2019-09-11
Summary of Product characteristics
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRAMADOL-ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
PRO DOC LTÉE
Date of Revision:
2925, boul. Industriel
December 12, 2018
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NUMBER: 221949
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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
.................................................................................
17
DRUG INTERACTIONS
.................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................ 25
OVERDOSAGE
.............................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
36
SPECIAL HANDLING INSTRUCTIONS
....................................................... 37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 37
PART II: SCIENTIFIC INFORMATION
................................................................. 38
PHARMACEUTICAL INFORMATION
............................................................ 38
CLINICAL TRIALS
........................................................................................
39
DETAILED PHARMACOLOGY
......................................................................
43
TOXICOLOGY...............................
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