MYLAN-SILDENAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SILDENAFIL (SILDENAFIL CITRATE)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

G04BE03

INN (International Name):

SILDENAFIL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Administration route:

ORAL

Units in package:

4/30

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0136261003; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-01-11

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
MYLAN-SILDENAFIL
SILDENAFIL CITRATE TABLETS
25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
September 2, 2015
Submission Control No.: 187004
2
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
..............................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
....................