SILDENAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-11-2018
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
PHARMASCIENCE INC
ATC code:
G04BE03
INN (International Name):
SILDENAFIL
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
SILDENAFIL (SILDENAFIL CITRATE) 100MG
Administration route:
ORAL
Units in package:
4/6/8/30
Prescription type:
Prescription
Therapeutic area:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0136261003; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-11-08
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
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
November 07, 2018
Montréal, Québec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 221660
_SILDENAFIL Product Monograph _
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
.....................................................................................................
13
DOSAGE AND ADMINISTRATION
.................................................................................
17
OVERDOSAGE
...................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 19
STORAGE AND STABILITY
............................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
.....................................................................................
23
PHARMACEUTICAL INFORMATION
............................................................................
23
CLINICAL
TRIALS..................................
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