FIORINAL-C 1/2 CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-07-2023
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Active ingredient:
ACETYLSALICYLIC ACID; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL
Available from:
ARALEZ PHARMACEUTICALS CANADA INC
ATC code:
N02AA79
INN (International Name):
CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
Dosage:
330MG; 40MG; 30MG; 50MG
Pharmaceutical form:
CAPSULE
Composition:
ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG; BUTALBITAL 50MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0401238001; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-12-01
Summary of Product characteristics
Page 1 of 47
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.
6733 Mississauga Rd., Suite 800
Mississauga, Ontario
L5N 6J5
www.miravohealthcare.com
Date of Revision:
July 18, 2023
Submission Control No: 270298
Page 2 of 47
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
..................................................................................................17
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
................................................................................31
PHARMACEUTICAL INFORMATION
...............................................
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