APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GLICLAZIDE

MAH:

APOTEX INC

ATC_code:

A10BB09

INN:

GLICLAZIDE

dosage:

30MG

pharmaceutical_form:

TABLET (EXTENDED-RELEASE)

composition:

GLICLAZIDE 30MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

SULFONYLUREAS

leaflet_short:

Active ingredient group (AIG) number: 0119934002; AHFS:

authorization_status:

APPROVED

authorization_date:

2008-06-04

SPC

PRODUCT MONOGRAPH
Pr
APO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
December 27, 2019
TORONTO ONTARIO
M9L 1T9
CONTROL NO: 233440
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
15
OVERDOSAGE
.........................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
17
STORAGE AND STABILITY
..................................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCI