MAR-TADALAFIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TADALAFIL

Tersedia dari:

MARCAN PHARMACEUTICALS INC

Kode ATC:

G04BE08

INN (Nama Internasional):

TADALAFIL

Dosis:

20MG

Bentuk farmasi:

TABLET

Komposisi:

TADALAFIL 20MG

Rute administrasi :

ORAL

Unit dalam paket:

4/28/30/56/100/500

Jenis Resep:

Prescription

Area terapi:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-07-12

Karakteristik produk

Page 1 of 49
PRODUCT MONOGRAPH
Pr
MAR-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)
Marcan Pharmaceuticals Inc.
DATE OF REVISION:
77 Auriga Drive, Unit# 4,
July 17, 2017
Ottawa, Ontario
K2E 7Z7
Control# 207439
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
......................................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
16
STORAGE AND STABILITY
...............................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PART II: SCIENTIFIC INFORMATION
........................