PMS-TRAMADOL-ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-09-2022
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
PHARMASCIENCE 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:
30/100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0250601001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-02-08
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-TRAMADOL-ACET
Tramadol Hydrochloride and Acetaminophen Tablets, House Standard
37.5 mg tramadol hydrochloride
/ 325 mg acetaminophen
OPIOD ANALGESIC AND CENTRALLY ACTING ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
September 27, 2022
SUBMISSION CONTROL NO: 264215
_pms-TRAMADOL-ACET Product Monograph _
_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.................................................................................
5
ADVERSE
REACTIONS................................................................................................
19
DRUG INTERACTIONS
................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE
..............................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY...........................................................
33
STORAGE AND STABILITY
........................................................................................
41
SPECIAL HANDLING
INSTRUCTIONS......................................................................
41
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 41
PART II: SCIENTIFIC INFORMATION
..........................................................................
42
PHARMACEUTICAL INFORMATION
...................................
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