RIVA-SILDENAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SILDENAFIL (SILDENAFIL CITRATE)

Available from:

LABORATOIRE RIVA INC.

ATC code:

G04BE03

INN (International Name):

SILDENAFIL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Administration route:

ORAL

Units in package:

4/8/30

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0136261003; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-07-20

Summary of Product characteristics

_RIVA-SILDENAFIL - Product Monograph _
_Page 1 of 54_
PRODUCT MONOGRAPH
PR
RIVA-SILDENAFIL
Sildenafil Citrate Tablets
Tablets, 25 mg, 50 mg and 100 mg Sildenafil
(as Sildenafil citrate)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.:
276533
DATE OF INITIAL APPROVAL:
April
22, 2016
DATE OF REVISION:
July 20, 2023
_RIVA-SILDENAFIL - Product Monograph _
_Page 2 of 54_
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
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
.......................................................................