BIO-ZOPICLONE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ZOPICLONE

Tilgængelig fra:

BIOMED PHARMA

ATC-kode:

N05CF01

INN (International Name):

ZOPICLONE

Dosering:

7.5MG

Lægemiddelform:

TABLET

Sammensætning:

ZOPICLONE 7.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

(3X10)/100/500

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Produkt oversigt:

Active ingredient group (AIG) number: 0122562001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2018-09-20

Produktets egenskaber

Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
BIO-ZOPICLONE
Zopiclone Tablets
Tablets, 3.75 mg, 5 mg and 7.5 mg, Oral
House Standard
Hypnotic and Sedative
Biomed Pharma
1B-9450 Boulevard Langelier
Montreal, Quebec
H1P3H8, Canada
Date of Initial Authorization:
SEP 20, 2018
Date of Revision:
MAY 19, 2023
Submission Control Number: 273689
Page 2 of 38
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
05/2023
3 Serious Warnings and Precautions Box
05/2023
4 Dosage and Administration, 4.1 Dosing Considerations
05/2023
7 Warnings and Precautions
05/2023
TABLE OF CONTENTS
_ _
_Sections or subsections that are not applicable at the time of
authorization are not listed._
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics (< 18 years of age)
...................................................................................
4
1.2
Geriatrics (

65 years of age)
..................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
4.4
Administration
.....................................