RASILEZ HCT TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALISKIREN (ALISKIREN FUMARATE); HYDROCHLOROTHIAZIDE

Available from:

NODEN PHARMA DAC

ATC code:

C09XA52

INN (International Name):

ALISKIREN AND HYDROCHLOROTHIAZIDE

Dosage:

300MG; 25MG

Pharmaceutical form:

TABLET

Composition:

ALISKIREN (ALISKIREN FUMARATE) 300MG; HYDROCHLOROTHIAZIDE 25MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

RENIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0252648004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-02-11

Summary of Product characteristics

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_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
.......................................................................................