PB-SILDENAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-11-2013
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
PB PHARMA INC
ATC code:
G04BE03
INN (International Name):
SILDENAFIL
Dosage:
50.0MG
Pharmaceutical form:
TABLET
Composition:
SILDENAFIL (SILDENAFIL CITRATE) 50.0MG
Administration route:
ORAL
Units in package:
100
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:
2019-06-07
Summary of Product characteristics
_PB -SILDENAFIL _
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PRODUCT MONOGRAPH
PR
PB -SILDENAFIL
Sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
PB PHARMA
400-3871 Belanger Street, Montréal,
DATE OF PREPARATION:
Québec, Canada.
November 01, 2013
H1X 3M7
SUBMISSION CONTROL NO: 168869
_PB -SILDENAFIL _
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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................................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND
STABILITY............................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.........................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................18
PART II: SCIENTIFIC INFORMATION
......................................................................19
PHARMACEUTICAL
INFORMATION............................................................................1
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