PMS-SILDENAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SILDENAFIL (SILDENAFIL CITRATE)

Available from:

PHARMASCIENCE INC

ATC code:

G04BE03

INN (International Name):

SILDENAFIL

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Administration route:

ORAL

Units in package:

4

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0136261001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-11-13

Summary of Product characteristics

PRODUCT MONOGRAPH
PR PMS-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
August 9, 2016
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 196963
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_pms-SILDENAFIL Product Monograph _
_Page 2 of 49_
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
..............................................................................................................
13
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
..............