GLUMETZA (SB) TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

A10BA02

INN (International Name):

METFORMIN

Dosage:

1000MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

METFORMIN HYDROCHLORIDE 1000MG

Administration route:

ORAL

Units in package:

30/90/500/1000

Prescription type:

Prescription

Therapeutic area:

BIGUANIDES

Product summary:

Active ingredient group (AIG) number: 0101773003; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-12-22

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLUMETZA
®
Metformin Hydrochloride Extended- Release Tablets, Mfr. Std.
500 mg and 1000 mg
PR
GLUMETZA
® (SB)
Metformin Hydrochloride Extended- Release Tablets, Mfr. Std.
1000 mg
ORAL ANTIHYPERGLYCEMIC AGENT
BAUSCH HEALTH, CANADA INC. DATE OF INITIAL AUTHORIZATION:
2150 St-Elzear Blvd. West
November 03, 2015
Laval, Quebec
H7L 4A8
DATE OF REVISION:
February 14, 2023
Submission Control number: 264310
_Pr_
_GLUMETZA_
_®_
_ and GLUMETZA_
_®_
_ (SB) Product Monograph _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
...................................................... 5
4
DOSAGE AND
ADMINISTRATION..............................................................................
5
4.1
Dosing Considerations
........................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 6
4.4
Administration.....................................................................................................
7
4.5
Missed Dose
..........................................................................