APO-TEMAZEPAM CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TEMAZEPAM

Available from:

APOTEX INC

ATC code:

N05CD07

INN (International Name):

TEMAZEPAM

Dosage:

30MG

Pharmaceutical form:

CAPSULE

Composition:

TEMAZEPAM 30MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0114415001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-01-05

Summary of Product characteristics

_APO-TEMAZEPAM (Temazepam Capsules) _
_ _
_Page 1 of 31 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
APO-TEMAZEPAM
Temazepam Capsules
Capsules, 15 mg and 30 mg, Oral
USP
Hypnotic
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control
Number: 271083
Date of Initial Authorization:
AUG 06, 1996
Date of
Revision:
JAN
27, 2023
_APO-TEMAZEPAM (Temazepam Capsules) _
_ _
_Page 2 of 31 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
01/2023
3 Serious Warnings and Precautions Box
01/2023
4 Dosage and Administration, 4.1 Dosing considerations
01/2023
7 Warnings and Precautions
01/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
01/2023
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
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustme