SINEMET CR 100/25 TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-02-2014
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Active ingredient:
LEVODOPA; CARBIDOPA
Available from:
MERCK CANADA INC
ATC code:
N04BA02
INN (International Name):
LEVODOPA AND DECARBOXYLASE INHIBITOR
Dosage:
100MG; 25MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
LEVODOPA 100MG; CARBIDOPA 25MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
DOPAMINE PRECURSORS
Product summary:
Active ingredient group (AIG) number: 0210315003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-10-31
Summary of Product characteristics
_Product Monograph - SINEMET_
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_CR _
_Page 1 of 28 _
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PRODUCT MONOGRAPH
SINEMET
®
CR
levodopa and carbidopa controlled release tablets
100 mg/25 mg
100 mg levodopa and 25 mg carbidopa
200 mg/50 mg
200 mg levodopa and 50 mg carbidopa
Antiparkinson Agent
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC H9H 4M7
Canada
www.merck.ca
Date of Revision:
February 6, 2014
SUBMISSION CONTROL 169999
_Product Monograph - SINEMET_
_® _
_CR _
_Page 2 of 28 _
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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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
................................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
DETAILED PHARMACOLOGY
.......
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