LEVITRA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE)

Available from:

BAYER INC

ATC code:

G04BE09

INN (International Name):

VARDENAFIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE) 20MG

Administration route:

ORAL

Units in package:

4

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0150003003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-05-15

Summary of Product characteristics

__________________________________________________________________________________
_LEVITRA Product Monograph _
_Page 1 of 52 _
PRODUCT MONOGRAPH
Pr
LEVITRA
®
Vardenafil tablets
5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride
Bayer Standard
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
February 25, 2020
Submission Control No: 234111
© 2020, Bayer Inc.
® TM see www.bayer.ca/tm-mc
__________________________________________________________________________________
_LEVITRA Product Monograph _
_Page 2 of 52 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
15
TREATMENT OF PRIAPISM
.................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.....................