APO-SILDENAFIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SILDENAFIL (SILDENAFIL CITRATE)

Commercializzato da:

APOTEX INC

Codice ATC:

G04BE03

INN (Nome Internazionale):

SILDENAFIL

Dosaggio:

25MG

Forma farmaceutica:

TABLET

Composizione:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Via di somministrazione:

ORAL

Confezione:

4

Tipo di ricetta:

Prescription

Area terapeutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-11-09

Scheda tecnica

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_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