AG-SILDENAFIL TABLETS

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

SILDENAFIL (SILDENAFIL CITRATE)

MAH:

ANGITA PHARMA INC.

ATC_code:

G04BE03

INN:

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

leaflet_short:

Active ingredient group (AIG) number: 0136261002; AHFS:

authorization_status:

APPROVED

authorization_date:

2020-08-14

SPC

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