292 TABLETS

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ACETYLSALICYLIC ACID; CAFFEINE (CAFFEINE CITRATE); CODEINE PHOSPHATE

MAH:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC_code:

N02AJ07

INN:

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

leaflet_short:

Active ingredient group (AIG) number: 0301235005; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2021-04-29

SPC

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
.......................