IPG-SILDENAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-04-2019
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
G04BE03
INN (International Name):
SILDENAFIL
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
SILDENAFIL (SILDENAFIL CITRATE) 100MG
Administration route:
ORAL
Units in package:
4/8
Prescription type:
Prescription
Therapeutic area:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0136261003; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-09-12
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
IPG-SILDENAFIL
Sildenafil (as Sildenafil citrate)
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Marcan Pharmaceuticals Inc.
Date of Revision:
2 Gurdwara Road, Suite #112
April 29, 2019
Ottawa, ON, K2E 1A2
Control # 227005
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................
3
WARNINGS AND PRECAUTIONS
......................................................................................................
4
ADVERSE REACTIONS
........................................................................................................................
7
DRUG INTERACTIONS
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12
DOSAGE AND ADMINISTRATION
...................................................................................................
15
OVERDOSAGE
.....................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................
17
STORAGE AND STABILITY
..............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
............................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 20
PART II: SCIENTIFIC INFO
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