TARO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GLICLAZIDE

Disponible depuis:

SUN PHARMA CANADA INC

Code ATC:

A10BB09

DCI (Dénomination commune internationale):

GLICLAZIDE

Dosage:

30MG

forme pharmaceutique:

TABLET (EXTENDED-RELEASE)

Composition:

GLICLAZIDE 30MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SULFONYLUREAS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-05-04

Résumé des caractéristiques du produit

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_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
...................