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:

50MG

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

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: 0136261002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2016-02-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR RIVA-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
LABORATOIRE RIVA INC.
DATE OF PREPARATION:
660 Boul. Industriel
December 18, 2012
Blainville Québec
J7C 3V4
SUBMISSION CONTROL NO: 160584
_Riva-SILDENAFIL V Product Monograph Page 2 of 46_
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
..........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND
STABILITY.................................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 19
PART II: SCIENTIFIC INFORMATION
.....................................................................................
21
PHARMACEUTICAL INFOR