BIO-TRAMADOL/ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-06-2018
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
BIOMED PHARMA
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:
30/60/100/500
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0250601001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2021-09-10
Summary of Product characteristics
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BIO-TRAMADOL/ACET
Acetaminophen and Tramadol Hydrochloride Tablets, House Std.
37.5 mg Tramadol Hydrochloride/325 mg Acetaminophen
Centrally Acting Analgesic
Date of preparation
June 7, 2018
Biomed Pharma
1565 boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Control# 215703
_Page 2 of 56 _
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
.......................................................................................................................
15
DRUG INTERACTIONS
.......................................................................................................................
20
DOSAGE AND ADMINISTRATION
...................................................................................................
23
OVERDOSAGE
......................................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
27
STORAGE AND STABILITY
...............................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 33
PART II: SCIENTIFIC INFORMATION
.............................................................
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