Country: Canada
Language: English
Source: Health Canada
ALISKIREN (ALISKIREN FUMARATE); HYDROCHLOROTHIAZIDE
NODEN PHARMA DAC
C09XA52
ALISKIREN AND HYDROCHLOROTHIAZIDE
150MG; 25MG
TABLET
ALISKIREN (ALISKIREN FUMARATE) 150MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
28
Prescription
RENIN INHIBITORS
Active ingredient group (AIG) number: 0252648001; AHFS:
CANCELLED POST MARKET
2020-02-11
_ _ _Page 1 of 46_ PRODUCT MONOGRAPH PR RASILEZ HCT ® ALISKIREN (AS ALISKIREN FUMARATE) & HYDROCHLOROTHIAZIDE TABLETS 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg and 300 mg /25 mg Renin inhibitor and diuretic Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland Date of Preparation: September 2, 2009 Date of revision: August 7, 2019 Control No. 228128 ® RASILEZ HCT is a Registered trademark _ _ _Page 2 of 46_ 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 ................................................................................................11 DRUG INTERACTIONS ................................................................................................17 DOSAGE AND ADMINISTRATION ...........................................................................25 OVERDOSAGE ...............................................................................................................26 ACTION AND CLINICAL PHARMACOLOGY ........................................................26 STORAGE AND STABILITY........................................................................................31 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................31 PART II: SCIENTIFIC INFORMATION ...............................................................................33 PHARMACEUTICAL INFORMATION ......................................................................33 CLINICAL TRIALS ....................................................................................... Read the complete document