ACH-METFORMIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-02-2021
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Active ingredient:
METFORMIN HYDROCHLORIDE
Available from:
ACCORD HEALTHCARE 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:
2021-03-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
ACH-METFORMIN
Metformin Hydrochloride Tablets, Mfr Std
500 mg and 850 mg tablets
Oral Antihyperglycemic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
DATE OF REVISION:
FEBRUARY 23, 2021
SUBMISSION CONTROL NO.: 244440
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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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
CLINICAL TRIALS
........................................................................................
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