APO-SILDENAFIL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SILDENAFIL (SILDENAFIL CITRATE)

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

G04BE03

INN (Isem Internazzjonali):

SILDENAFIL

Dożaġġ:

50MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

4

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2012-11-09

Karatteristiċi tal-prodott

_ _
_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