MYLAN-TADALAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TADALAFIL

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

G04BE08

INN (International Name):

TADALAFIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

TADALAFIL 20MG

Administration route:

ORAL

Units in package:

4/30

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0149485002; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-12

Summary of Product characteristics

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_Page 1 of 52_
PRODUCT MONOGRAPH
PR MYLAN-TADALAFIL
Tadalafil Tablets, USP
2.5 mg, 5 mg Tablets (for _Once-a-day _use),
10 mg, 20 mg Tablets (for _“On-Demand” _dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF ERECTILE DYSFUNCTION AND
BENIGN PROSTATIC HYPERPLASIA (ED/BPH)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
February 7, 2017
Submission Control No: 201793
_ _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
...........................................