ALTACE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-01-2021
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Active ingredient:
RAMIPRIL
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
C09AA05
INN (International Name):
RAMIPRIL
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
RAMIPRIL 10MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122858002; AHFS:
Authorization status:
APPROVED
Authorization date:
1996-06-05
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
ALTACE
®
Ramipril Capsules, USP
Capsules 1.25 mg, 2.5 mg, 5.0 mg, 10.0 mg, and 15 mg
Ramipril Tablets, USP
Tablets 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg
ATC CODE: C09AA05
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
January 8, 2021
Laval, Quebec
H7L 4A8
Control #: 239641
_Pr_
_ALTACE_
_®_
_ Product Monograph _
_Page 2 of 42_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY
PRODUCT
INFORMATION
..................................................................................
3
INDICATIONS
AND
CLINICAL
USE
........................................................................................
4
CONTRAINDICATIONS
.............................................................................................................
5
WARNINGS
AND
PRECAUTIONS
............................................................................................
6
ADVERSE
REACTIONS
............................................................................................................
13
DRUG
INTERACTIONS
............................................................................................................
18
DOSAGE
AND
ADMINISTRATION
........................................................................................
21
OVERDOSAGE
..........................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
24
STORAGE
AND
STABILITY
....................................................................................................
27
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
30
PHARMACEUTICAL
INFORMATION
................................
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