TADALAFIL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TADALAFIL

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

G04BE08

INN (Internationale Bezeichnung):

TADALAFIL

Dosierung:

2.5MG

Darreichungsform:

TABLET

Zusammensetzung:

TADALAFIL 2.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30

Verschreibungstyp:

Prescription

Therapiebereich:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2020-12-18

Fachinformation

_Page 1 of 50_
PRODUCT MONOGRAPH
PR
TADALAFIL
Tadalafil Tablets
Teva Standard
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)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 17, 2020
Toronto, Ontario
M1B 2K9
Control No.: 242140
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_TADALAFIL Product Monograph _
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
....................................................................................................
8
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 16
STORAGE AND STABILITY
..........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
2