ADALAT XL TABLET (EXTENDED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

NIFEDIPINE

Disponible depuis:

BAYER INC

Code ATC:

C08CA05

DCI (Dénomination commune internationale):

NIFEDIPINE

Dosage:

20MG

forme pharmaceutique:

TABLET (EXTENDED-RELEASE)

Composition:

NIFEDIPINE 20MG

Mode d'administration:

ORAL

Unités en paquet:

28/98

Type d'ordonnance:

Prescription

Domaine thérapeutique:

DIHYDROPYRIDINES

Descriptif du produit:

Active ingredient group (AIG) number: 0115253002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2020-12-09

Résumé des caractéristiques du produit

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
......