292 TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-06-2018
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Active ingredient:
ACETYLSALICYLIC ACID; CAFFEINE (CAFFEINE CITRATE); CODEINE PHOSPHATE
Available from:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC code:
N02AJ07
INN (International Name):
CODEINE AND ACETYLSALICYLIC ACID
Dosage:
375MG; 15MG; 30MG
Pharmaceutical form:
TABLET
Composition:
ACETYLSALICYLIC ACID 375MG; CAFFEINE (CAFFEINE CITRATE) 15MG; CODEINE PHOSPHATE 30MG
Administration route:
ORAL
Units in package:
50/500
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0301235005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-04-29
Summary of Product characteristics
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N.
282
®
ACETYLSALICYLIC ACID (375 MG), CODEINE PHOSPHATE (15 MG),
CAFFEINE (15 MG*) TABLETS
*
equivalent to 30 mg caffeine citrate
N.
292
®
ACETYLSALICYLIC ACID (375 MG), CODEINE PHOSPHATE (30 MG),
CAFFEINE (15 MG*) TABLETS
*
equivalent to 30 mg caffeine citrate
ANALGESIC
ANTIPYRETIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
June 22, 2018
SUBMISSION CONTROL NO.:
214268
282
and 292
are registered trademarks of Pharmascience Inc.
_282_
_®_
_ and 292_
_®_
_ Prescribing Information _
_Page 2 of 33_
_ _
TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION
.......................
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