Maa: Kanada
Kieli: englanti
Lähde: Health Canada
SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
TEVA CANADA LIMITED
C03EA01
HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS
50MG; 50MG
TABLET
SPIRONOLACTONE 50MG; HYDROCHLOROTHIAZIDE 50MG
ORAL
100/500/1000
Prescription
MINERALOCORTICOID (ALDOSTERONE) RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0201064002; AHFS:
APPROVED
2011-06-14
TEVA-SPIRONOLACTONE/HCTZ Page 1 of 49 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-SPIRONOLACTONE/HCTZ Spironolactone and Hydrochlorothiazide Tablets, Tablets, 25 mg of spironolactone and 25 mg of hydrochlorothiazide 50 mg of spironolactone and 50 mg of hydrochlorothiazide, Oral USP Aldosterone Antagonist / Diuretic Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court June 28, 2011 Toronto, Ontario Canada M1B 2K9 Date of Revision: www.tevacanada.com October 20, 2022 Submission Control No: 264744 TEVA-SPIRONOLACTONE/HCTZ Page 2 of 49 RECENT MAJOR LABEL CHANGES WARNINGS AND PRECAUTIONS 10/2022 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 ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.1 Dosing Considerations ...................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment.................................................... 6 4.4 Adminisrtat Lue koko asiakirja