TEVA-TADALAFIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TADALAFIL

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

G04BE08

INN (Nome Internazionale):

TADALAFIL

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

TADALAFIL 5MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-07-12

Scheda tecnica

1
PRODUCT MONOGRAPH
PR
TEVA-TADALAFIL
Tadalafil Tablets USP
2.5 mg and 5 mg Tablets (for _Once-a-Day _use)
10 mg and 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
February 1, 2017
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No.: 202075
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
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
.......................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................