NIFEDIPINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NIFEDIPINE

Available from:

AA PHARMA INC

ATC code:

C08CA05

INN (International Name):

NIFEDIPINE

Dosage:

5MG

Pharmaceutical form:

CAPSULE

Composition:

NIFEDIPINE 5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

DIHYDROPYRIDINES

Product summary:

Active ingredient group (AIG) number: 0115253003; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-06-14

Summary of Product characteristics

_NIFEDIPINE (Nifedipine Capsules) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NIFEDIPINE
Nifedipine Capsules
Capsules, 5 mg and 10 mg, Oral
USP
Anti-Anginal Agent
AA PHARMA INC.
1165 Creditstone Road Unit # 1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca/en/
Date of Initial Authorization:
JUN 16, 2010
Date of Revision:
DEC 01, 2023
Submission Control Number: 271662
_NIFEDIPINE (Nifedipine Capsules) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
None
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
...............................................................................