Country: Canada
Language: English
Source: Health Canada
AMLODIPINE (AMLODIPINE BESYLATE)
NORA PHARMA INC
C08CA01
AMLODIPINE
5MG
TABLET
AMLODIPINE (AMLODIPINE BESYLATE) 5MG
ORAL
100/250
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0131437002; AHFS:
APPROVED
2023-12-05
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 .......................................................................................... 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................................................................... Read the complete document