NRA-AMLODIPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMLODIPINE (AMLODIPINE BESYLATE)

Available from:

NORA PHARMA INC

ATC code:

C08CA01

INN (International Name):

AMLODIPINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Administration route:

ORAL

Units in package:

100/250

Prescription type:

Prescription

Therapeutic area:

DIHYDROPYRIDINES

Product summary:

Active ingredient group (AIG) number: 0131437001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-12-05

Summary of Product characteristics

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NRA-AMLODIPINE
Amlodipine BesylateTablets
Tablets,2.5 mg,5 mgand 10mgamlodipine(asamlodipinebesylate), Oral
HouseStd.
Antihypertensive-AntianginalAgent
Nora Pharma Inc.
1565 Lionel-BouletBlvd,
Varennes,Quebec,J3X 1P7
DateofInitial Authorization:
MAY 30,2018
DateofRevision:
DEC05,2023
SubmissionControlNumber: 279870
2
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
Sections or subsections that are not applicable at
thetimeofauthorizationare not listed.
RECENTMAJOR LABEL CHANGES
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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 Doseand Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
.............................................................................................................
5
5
OVERDOSAGE...................................................................