GLUCOPHAGE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

A10BA02

INN (International Name):

METFORMIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

METFORMIN HYDROCHLORIDE 500MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

BIGUANIDES

Product summary:

Active ingredient group (AIG) number: 0101773001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-05-12

Summary of Product characteristics

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_Page 1 of 39_
PRODUCT MONOGRAPH
Pr
GLUCOPHAGE
®
Metformin Hydrochloride Tablets
Manufacturer’s standard
500 mg, 850 mg
Oral Antihyperglycemic Agent
®
Registered trade mark of Merck Santé. Used under licence
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) H7V 0A3
Date of revision :
March 2, 2018
Submission Control No.: 211582
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_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION................................................................................
3
INDICATIONS
AND
CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
13
DRUG
INTERACTIONS
.........................................................................................................
15
DOSAGE
AND
ADMINISTRATION
.....................................................................................
18
OVERDOSAGE........................................................................................................................
20
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
21
STORAGE
AND
STABILITY
.................................................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION
.................................................................................
23
CLINICAL
TRIALS
..