RAN-TADALAFIL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TADALAFIL

Disponible desde:

RANBAXY PHARMACEUTICALS CANADA INC.

Código ATC:

G04BE08

Designación común internacional (DCI):

TADALAFIL

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

TADALAFIL 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

4/28/30/56/100/500

tipo de receta:

Prescription

Área terapéutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-07-12

Ficha técnica

Page 1 of 48
PRODUCT MONOGRAPH
PR
RAN™-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)
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
July 17, 2017
Brampton, Ontario
L6T 1C1
Control# 207323
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 48
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
PAR