SANDOZ GLIMEPIRIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-02-2021
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Active ingredient:
GLIMEPIRIDE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosage:
4MG
Pharmaceutical form:
TABLET
Composition:
GLIMEPIRIDE 4MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0146247003; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-01-27
Summary of Product characteristics
_Sandoz Glimepiride _
_ Page 1 of 48 _
PRODUCT MONOGRAPH
PR
SANDOZ GLIMEPIRIDE
Glimepiride Tablets
1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
February 4, 2021
Boucherville,
Quebec
J4B 1E6
Submission
Control No: 243337
_Sandoz Glimepiride _
_ Page 2 of 48 _
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...................................................................................................
11
DOSAGE AND
ADMINISTRATION................................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 16
STORAGE AND
STABILITY...........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 20
PART II: SCIENTIFIC INFORMATION
..........................................................................
22
PHARMACEUTICAL
INFORMATION............................................................................
22
CLINICAL TRIALS
..........................................................................................................
23
DETAILED PHARMACOLOGY
..............
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