AMARYL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-01-2017
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:
GLIMEPIRIDE
Available from:
SANOFI-AVENTIS CANADA INC
ATC code:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
GLIMEPIRIDE 1MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0146247001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-31
Summary of Product characteristics
_ _
_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
AMARYL
®
glimepiride
Tablets 1, 2 and 4 mg
Manufacturer’s standard
Oral Hypoglycemic (Sulfonylurea)
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
December 29, 2016
Submission Control No.: 198596
s-a Version 5.0 dated December 23, 2016
_ _
_ _
_Page 2 of 49_
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
................................................................................................
9
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 18
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
......................................................................
23
CLINICAL TRIALS
......................................................................................................
24
DETAILED PHARMACOLOGY
...................................
Read the complete document
