ADALAT XL TABLET (EXTENDED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NIFEDIPINE

Disponible desde:

BAYER INC

Código ATC:

C08CA05

Designación común internacional (DCI):

NIFEDIPINE

Dosis:

60MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

NIFEDIPINE 60MG

Vía de administración:

ORAL

Unidades en paquete:

28/98

tipo de receta:

Prescription

Área terapéutica:

DIHYDROPYRIDINES

Resumen del producto:

Active ingredient group (AIG) number: 0115253005; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-12-09

Ficha técnica

ADALAT XL
Page 1 of 34
PRODUCT MONOGRAPH
PR
ADALAT
® XL
®
Nifedipine extended-release tablets
20 mg, 30 mg and 60 mg nifedipine
Bayer Standard
Antianginal/Antihypertensive Agent
Manufactured by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Revision:
July 25, 2016
Submission Control No: 194331

2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc. All other trademarks are the property of
their respective
owners.
ADALAT XL
Page 2 of 34
TABLE OF CONTENTS
PART
I:
HEALTH
PROFESSIONAL
INFORMATION ..........................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
18
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
.................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 22
PART
II:
SCIENTIFIC
INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
......