MINT-TRAMADOL/ACET TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-03-2023
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Active ingredient:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Available from:
MINT PHARMACEUTICALS 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:
60/100
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
1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MINT-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario, L5T 2M3
Date of Revision:
March 6, 2023
Submission Control #: 269513
2 | P a g e
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
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
...................................................................................
288
OVERDOSAGE
......................................................................................................................
311
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 332
STORAGE AND STABILITY
.................................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
411
PHARM
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