SILDENAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-01-2016
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
METHAPHARM INC
ATC code:
G04BE03
INN (International Name):
SILDENAFIL
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
SILDENAFIL (SILDENAFIL CITRATE) 50MG
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:
APPROVED
Authorization date:
2016-01-18
Summary of Product characteristics
SILDENAFIL (sildenafil citrate) Product Monograph
Page 1 of 43
PRODUCT MONOGRAPH
PR SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
SUBMISSION CONTROL NO: 181471
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario N3S 7X6
DATE OF PREPARATION:
January 14, 2016
SILDENAFIL (sildenafil citrate) Product Monograph
Page 2 of 43
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
...........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.........................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
....................
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