COPHYLAC DROPS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-06-2020
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Active ingredient:
NORMETHADONE HYDROCHLORIDE; P-HYDROXYEPHEDRINE HYDROCHLORIDE
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
R05DA20
INN (International Name):
COMBINATIONS
Dosage:
10MG; 20MG
Pharmaceutical form:
DROPS
Composition:
NORMETHADONE HYDROCHLORIDE 10MG; P-HYDROXYEPHEDRINE HYDROCHLORIDE 20MG
Administration route:
ORAL
Units in package:
15ML
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
ANTITUSSIVES
Product summary:
Active ingredient group (AIG) number: 0204869001; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-11-02
Summary of Product characteristics
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
COPHYLAC
Normethadone HCl and p-Hydroxyephedrine HCl Drops
Drops, Normethadone HCl 10 mg/mL (1%) and p-Hydroxyephedrine HCl 20
mg/mL (2%)
ANTITUSSIVE
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
DATE OF REVISION:
June 24, 2020
Submission Control No: 230752
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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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
PART III: CONSUMER MEDICATION INFORMATION
..................................................16
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N
COPHYLAC
Normethadone Hydrochloride and p
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