PRZ-TADALAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TADALAFIL

Available from:

PHARMARIS CANADA INC

ATC code:

G04BE08

INN (International Name):

TADALAFIL

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

TADALAFIL 2.5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0149485003; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-02-08

Summary of Product characteristics

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_Page 1 of 51 _
PRODUCT MONOGRAPH
PR
PRZ-TADALAFIL
Tadalafil Tablets, House Standard
2.5 mg, 5 mg tablets (for _Once-a-Day _use)
10 mg, 20 mg tablets (for
_“On_
_-_
_Demand” _
dosi
ng)
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)
Pharmaris Canada Inc.
8310 130
th
Street, Unit #102
Date of Preparation:
Surrey, British Columbia
February 5, 2021
V3W 8J9
Control Number:
227153
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_Page 2 of 51 _
TABLE OF CONT
E
NTS
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 TRIALS
....................................................................