TARO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-03-2020
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
GLICLAZIDE
Available from:
SUN PHARMA CANADA INC
ATC code:
A10BB09
INN (International Name):
GLICLAZIDE
Dosage:
60MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
GLICLAZIDE 60MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0119934003; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-04-02
Summary of Product characteristics
_Pr_
_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
TARO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 11, 2020
Submission Control No.: 236213
_Pr_
_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
_ _
_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
8
DRUG INTERACTIONS
...............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
..............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 18
STORAGE AND STABILITY
.......................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
...................
Read the complete document
