PRAMIPEXOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-08-2021
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Available from:
SANIS HEALTH INC
ATC code:
N04BC05
INN (International Name):
PRAMIPEXOLE
Dosage:
1.5MG
Pharmaceutical form:
TABLET
Composition:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0152169004; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-07-12
Summary of Product characteristics
Page 1 of 56
PRODUCT MONOGRAPH
PR
PRAMIPEXOLE
Pramipexole Dihydrochloride Tablets
0.25 mg, 0.5 mg, 1 mg & 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian
Agent / Dopamine Agonist
SANIS HEALTH INC.
Date of Preparation:
1 President’s Choice Circle
August 16, 2021
Brampton, Ontario
L6Y 5S5
Submission
Control No.: 243205
Page 2 of 56
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
..................................................................................................10
DRUG INTERACTIONS
...................................................................................................19
DOSAGE AND ADMINISTRATION
...............................................................................21
OVERDOSAGE
.................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY..............................................................25
STORAGE AND STABILITY
...........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
........................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................29
PART II: SCIENTIFIC INFORMATION
........................................................................31
PHARMACEUTICAL INFORMATION
...........................................................................31
CLINICAL TRIALS
...........................................................
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