SYNJARDY TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

A10BD20

INN (International Name):

METFORMIN AND EMPAGLIFLOZIN

Dosage:

12.5MG; 500MG

Pharmaceutical form:

TABLET

Composition:

EMPAGLIFLOZIN 12.5MG; METFORMIN HYDROCHLORIDE 500MG

Administration route:

ORAL

Units in package:

10/60

Prescription type:

Prescription

Therapeutic area:

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors

Product summary:

Active ingredient group (AIG) number: 0258370004; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-29

Summary of Product characteristics

_ _
_ _
_Product Monograph _
_ _
Synjardy
®
_ _
(Empagliflozin and metformin hydrochloride)
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_Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SYNJARDY
®
Empagliflozin and metformin hydrochloride
Tablets, 5 mg/500 mg, 5 mg/850 mg, 5 mg/1000 mg, 12.5 mg/500 mg, 12.5
mg/850 mg,
12.5 mg/1000 mg, Oral
Combinations of oral blood glucose lowering drugs
Boehringer Ingelheim (Canada) Ltd
5180 South Service Rd
Burlington, ON L7L 5H4
Date of Initial Authorization:
JUL 29, 2016
Date of Revision:
MAR 15, 2023
Submission Control Number: 268593
BICL: 0289-17-18
Synjardy
®
is a trademark used under license by Boehringer Ingelheim (Canada)
Ltd.
_ _
_ _
_ _
_Product Monograph _
_ _
Synjardy
®
_ _
(Empagliflozin and metformin hydrochloride)
_ _
_Page 2 of 79_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
03/2023
2 CONTRAINDICATIONS
03/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment, Geriatrics (≥65 years of age), Renal Impairment, Hepatic
Impairment
03/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
03/2023
7 WARNINGS AND PRECAUTIONS, Renal, 7.1.4 Geriatrics
03/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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5
1.1
Pediatrics
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5
1.2
Geriatrics
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