FIORINAL-C 1/4 CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ACETYLSALICYLIC ACID; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE

Fáanlegur frá:

ARALEZ PHARMACEUTICALS CANADA INC

ATC númer:

N02AA79

INN (Alþjóðlegt nafn):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Skammtar:

330MG; 40MG; 50MG; 15MG

Lyfjaform:

CAPSULE

Samsetning:

ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; BUTALBITAL 50MG; CODEINE PHOSPHATE 15MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0401238002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2015-12-01

Vara einkenni

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