SEPTA-CANDESARTAN HCTZ TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL

Disponible depuis:

SEPTA PHARMACEUTICALS INC

Code ATC:

C09DA06

DCI (Dénomination commune internationale):

CANDERSARTAN AND DIURETICS

Dosage:

12.5MG; 32MG

forme pharmaceutique:

TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5MG; CANDESARTAN CILEXETIL 32MG

Mode d'administration:

ORAL

Unités en paquet:

30/80/1000

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0244181002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-04-29

Résumé des caractéristiques du produit

Page 1 of 38
_Septa-Candesartan HCTZ_
PRODUCT
MONOGRAPH
PR
SEPTA-CANDESARTAN HCTZ
CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE TABLETS
32 MG / 12.5 MG,
32 MG / 25 MG
ANGIOTENSIN II AT1 RECEPTOR BLOCKER + DIURETIC
Septa Pharmaceuticals Inc
Date of Preparation:
7490 Pacific Circle, # 1
April 22, 2015
Mississauga, ON L5T 2A3
Canada
Submission Control Number : 183582
Page 2 of 38
_Septa-Candesartan HCTZ_
TABLE OF CONTENTS
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
9
DRUG INTERACTIONS
...............................................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................................
18
OVERDOSAGE
..............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
20
STORAGE AND STABILITY
.......................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 24
PART II: SCIENTIFIC INFORMATION
...................................................................................................................
25
PHARMACEUTICAL INFORMATION
..................................................