FIORINAL-C 1/4 CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-07-2018
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Active ingredient:
ACETYLSALICYLIC ACID; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE
Available from:
ARALEZ PHARMACEUTICALS CANADA INC
ATC code:
N02AA79
INN (International Name):
CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
Dosage:
330MG; 40MG; 50MG; 15MG
Pharmaceutical form:
CAPSULE
Composition:
ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; BUTALBITAL 50MG; CODEINE PHOSPHATE 15MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0401238002; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-12-01
Summary of Product characteristics
Page
1
of
44
PRODUCT INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
FIORINAL
®
-C ¼
N
FIORINAL
®
-C ½
(acetylsalicylic acid-caffeine-codeine-butalbital)
330-40-15-50 mg
330-40-30-50 mg
Capsules
USP
Combination Analgesic
Aralez Pharmaceuticals Canada Inc.
7100 West Credit Avenue, Suite 101
Mississauga, Ontario
L5N 0E4
Date of Revision:
July 16, 2018
Submission Control No: 213743
Page
2
of
44
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
.....................................................................
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