AG-SILDENAFIL TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-08-2020
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Active ingredient:
SILDENAFIL (SILDENAFIL CITRATE)
Available from:
ANGITA PHARMA 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:
2020-08-14
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
AG-SILDENAFIL TABLETS
Sildenafil (as Sildenafil citrate)
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
August
12, 2020
Date of
Revision
:
Submission
Control
No.:
239723
J4B 5H3
Boucherville,
Québec
1310 rue Nobel
Angita Pharma
Inc.
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
.......................................................................................................................
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: SCIE
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