TARO-TRAMADOL/ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-10-2023
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
SUN PHARMA CANADA 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:
2012-09-04
Summary of Product characteristics
N
TARO-TRAMADOL/ACET – Product Monograph
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
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TARO-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std.
37.5 mg tramadol hydrochloride / 325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Sun Pharma Canada Inc.
Date of Revision:
126 East Drive
October 25, 2023
Brampton, Ontario
L6T 1C1
Control No.: 272054
N
TARO-TRAMADOL/ACET – Product Monograph
Page 2 of 68
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
.....................................................................................
27
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
31
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 38
PART II: SCIENTIFIC INFORMATION
...............................................................................
39
PHARMACEUTICAL INFORMATION
.............
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