CIALIS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TADALAFIL

Available from:

ELI LILLY CANADA INC

ATC code:

G04BE08

INN (International Name):

TADALAFIL

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

TADALAFIL 5MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0149485004; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-09-11

Summary of Product characteristics

_ _
_ _
_CIALIS_
_®_
_ (tadalafil) Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
Pr
CIALIS
®
(tadalafil tablets)
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)
©
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario M1N 2E8
WWW.LILLY.CA
Date of Revision:
November 22, 2016
Control Number: 197461
_ _
_ _
_CIALIS_
_®_
_ (tadalafil) Product Monograph _
_Page 2 of 49 _
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
.......................................................................................
8
DRUG INTERACTIONS
.....................................................................................
11
DOSAGE AND ADMINISTRATION
................................................................. 14
OVERDOSAGE
....................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................ 17
STORAGE AND STABILITY
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................. 22
PART II: SCIENTIFIC INFORMATION
.....................................................................
23
PHARMACEUTICAL INFORMATION
............................................................. 23
CLINICAL TRIA