ROBAXISAL C 1/4 TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

METHOCARBAMOL; CODEINE PHOSPHATE; ACETYLSALICYLIC ACID

Fáanlegur frá:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC númer:

N02AA59

INN (Alþjóðlegt nafn):

CODEINE, COMBINATIONS EXCL. PSYCHOLEPTICS

Skammtar:

400MG; 16.2MG; 325MG

Lyfjaform:

TABLET

Samsetning:

METHOCARBAMOL 400MG; CODEINE PHOSPHATE 16.2MG; ACETYLSALICYLIC ACID 325MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0301256003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2010-11-08

Vara einkenni

Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ROBAXISAL
®
C ½
(methocarbamol, codeine phosphate and acetylsalicylic acid)
400 mg/32.4 mg/325 mg: per tablet
Skeletal Muscle Relaxant/Analgesic
GlaxoSmithKline Consumer Healthcare ULC
55 Standish Court, suite 450
Mississauga, ON
L5R 4B2
Date of Revision:
March 5, 2024
Submission Control No: 277714
Page 2 of 37
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...........................................................................................
16
DRUG INTERACTIONS
...........................................................................................
18
DOSAGE AND ADMINISTRATION
........................................................................
19
OVERDOSAGE
........................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY........................................................
21
STORAGE AND STABILITY
...................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
..........................................................................
24
PHARMACEUTICAL INFORMATION
....................................................................
24
PATIENT MEDICATION INFORMATION
.....................................................................
27
Page 3 of 37
N
ROBAXISAL
® C ½
(methocarbamol, codeine phosphate and acetylsali