PRAMIPEXOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-11-2021
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
N04BC05
INN (International Name):
PRAMIPEXOLE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0152169003; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-01-09
Summary of Product characteristics
_ _
_PRAMIPEXOLE Product Monograph _
_Page 1 of 59_
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
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Revision:
November 10, 2021
Submission control No.: 257831
_ _
_PRAMIPEXOLE Product Monograph _
_Page 2 of 59_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
12
DRUG
INTERACTIONS....................................................................................................
21
DOSAGE AND ADMINISTRATION
...............................................................................
23
OVERDOSAGE
..................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 27
STORAGE AND STABILITY
...........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 31
PART II: SCIENTIFIC INFORMATION
..........................................................................
33
CLINICAL TRIALS
.................
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