JAMP-OLMESARTAN HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Available from:

JAMP PHARMA CORPORATION

ATC code:

C09DA08

INN (International Name):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dosage:

20MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 20MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0252502001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

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_JAMP-Olmesartan HCTZ _
_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
JAMP-OLMESARTAN HCTZ
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg
Angiotensin II AT
1
Receptor Blocker - Diuretic
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
April 25, 2017
Boucherville, Québec
J4B 5H3
CONTROL NO.:
201552,
203999
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_JAMP-Olmesartan HCTZ Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.......................................................................