FIORINAL-C 1/2 CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ACETYLSALICYLIC ACID; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL

Disponible depuis:

ARALEZ PHARMACEUTICALS CANADA INC

Code ATC:

N02AA79

DCI (Dénomination commune internationale):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Dosage:

330MG; 40MG; 30MG; 50MG

forme pharmaceutique:

CAPSULE

Composition:

ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG; BUTALBITAL 50MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Narcotic (CDSA I)

Domaine thérapeutique:

OPIATE AGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0401238001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-12-01

Résumé des caractéristiques du produit

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