APO-SILDENAFIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SILDENAFIL (SILDENAFIL CITRATE)

Tilgjengelig fra:

APOTEX INC

ATC-kode:

G04BE03

INN (International Name):

SILDENAFIL

Dosering :

25MG

Legemiddelform:

TABLET

Sammensetning:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Administreringsrute:

ORAL

Enheter i pakken:

4

Resept typen:

Prescription

Terapeutisk område:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0136261001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-11-09

Preparatomtale

_ _
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
PR
APO-SILDENAFIL
Sildenafil Tablets
Tablets, 25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
Apotex Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
April 5, 2023
Submission Control No: 268822
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 2 of 57_
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
.....................................................................................16
OVERDOSAGE
........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
.................................................................................................21
SPECIAL HANDLING INSTRUCTIONS
...............................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................21
PART II: SCIENTIFIC IN