ADALAT XL TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NIFEDIPINE

Disponibil de la:

BAYER INC

Codul ATC:

C08CA05

INN (nume internaţional):

NIFEDIPINE

Dozare:

20MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

NIFEDIPINE 20MG

Calea de administrare:

ORAL

Unități în pachet:

28/98

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

DIHYDROPYRIDINES

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2020-12-09

Caracteristicilor produsului

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
......