APO-SILDENAFIL R TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-02-2019
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
APOTEX INC
ATC code:
C02KX
INN (International Name):
ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
SILDENAFIL (SILDENAFIL CITRATE) 20MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0136261004; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-12-17
Summary of Product characteristics
Page 1 of 54
PRODUCT MONOGRAPH
Pr
APO-SILDENAFIL R
SILDENAFIL TABLETS USP
20 MG SILDENAFIL (AS SILDENAFIL CITRATE)
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
FEBRUARY 11, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO:
224315
Page 2 of 54
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
...........................................................................................................
9
DOSAGE AND ADMINISTRATION
.......................................................................................
20
OVERDOSAGE
......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 25
PART II: SCIENTIFIC INFORMATION ...................................................................................
26
PHARMACEUTICAL INFORMATION
...................................................................................
26
CLINICAL TRIALS
..............................
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