SILDENAFIL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SILDENAFIL (SILDENAFIL CITRATE)

Disponibbli minn:

METHAPHARM INC

Kodiċi ATC:

G04BE03

INN (Isem Internazzjonali):

SILDENAFIL

Dożaġġ:

50MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

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:

2016-01-18

Karatteristiċi tal-prodott

SILDENAFIL (sildenafil citrate) Product Monograph
Page 1 of 43
PRODUCT MONOGRAPH
PR SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
SUBMISSION CONTROL NO: 181471
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario N3S 7X6
DATE OF PREPARATION:
January 14, 2016
SILDENAFIL (sildenafil citrate) Product Monograph
Page 2 of 43
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
...................................................................................................10
DOSAGE AND ADMINISTRATION
...............................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND STABILITY
...........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.........................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
....................