JAMP-VARDENAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE)

Available from:

JAMP PHARMA CORPORATION

ATC code:

G04BE09

INN (International Name):

VARDENAFIL

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE) 5MG

Administration route:

ORAL

Units in package:

4

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0150003001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-11-01

Summary of Product characteristics

_JAMP-VARDENAFIL Product Monograph_
_Page 1 of 52_
PRODUCT MONOGRAPH
PR
JAMP-VARDENAFIL
Vardenafil tablets
5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride
House Standard
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Submission Control No: 249077
Date of Revision:
March 4, 2021
_JAMP-VARDENAFIL 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
.....................................................................................................
8
DRUG INTERACTIONS
...................................................................................................
10
DOSAGE AND
ADMINISTRATION.................................................................................
13
OVERDOSAGE.................................................................................................................
14
TREATMENT OF
PRIAPISM............................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 15
STORAGE AND
STABILITY............................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 19
PART II: SCIENTIFIC INFORMATION
.....................................................................