GLUCOPHAGE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-09-2015
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Active ingredient:
METFORMIN HYDROCHLORIDE
Available from:
SANOFI-AVENTIS CANADA INC
ATC code:
A10BA02
INN (International Name):
METFORMIN
Dosage:
1000MG
Pharmaceutical form:
TABLET
Composition:
METFORMIN HYDROCHLORIDE 1000MG
Administration route:
ORAL
Units in package:
30/60/100/120/500
Prescription type:
Prescription
Therapeutic area:
BIGUANIDES
Product summary:
Active ingredient group (AIG) number: 0101773003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-06-28
Summary of Product characteristics
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_Page 1 of 35_
PRODUCT MONOGRAPH
GLUCOPHAGE
®
Metformin Hydrochloride Tablets
Manufacturer’s standard
500 mg, 850 mg, and 1000 mg tablets
Oral Antihyperglycemic Agent
sanofi-aventis Canada Inc.
Date of Revision:
2150 St. Elzear Blvd. West
September 10, 2015
Laval, Quebec H7L 4A8
Submission Control No.:156892
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_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
6
ADVERSE
REACTIONS
.........................................................................................................
12
DRUG
INTERACTIONS
.........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
18
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
18
STORAGE
AND
STABILITY
.................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION
.................................................................................
21
CLINICAL
TRIALS
...........................................
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