TRAMADOL/ACET TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Available from:

SANIS HEALTH 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:

CANCELLED POST MARKET

Authorization date:

2020-12-16

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
SANIS HEALTH INC.
Date of Revision:
1 President’s Choice Circle November 27, 2018
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NUMBER: 221806
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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
.............................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
35
SPECIAL HANDLING INSTRUCTIONS
....................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 36
PART II: SCIENTIFIC INFORMATION
................................................................. 37
PHARMACEUTICAL INFORMATION
............................................................ 37
CLINICAL TRIALS
........................................................................................
38
DETAILED PHARMACOLOGY
......................................................................
42
TOXICOLOGY................