CARBOLITH CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-11-2023
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Active ingredient:
LITHIUM CARBONATE
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
N05AN01
INN (International Name):
LITHIUM
Dosage:
600MG
Pharmaceutical form:
CAPSULE
Composition:
LITHIUM CARBONATE 600MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANTIMANIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0101163003; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-06-03
Summary of Product characteristics
_Pr_
_CARBOLITH _
_®_
_ Lithium Carbonate Capsules Product Monograph Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CARBOLITH
®
Lithium Carbonate Capsules
Capsules,150, 300 and 600 mg, Oral
USP
Antimanic Agent
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
October 12, 2004
Date of Revision:
November 22, 2023
Submission Control Number: 275931
_ _
_Pr_
_CARBOLITH_
_®_
_ Lithium Carbonate Capsules Product Monograph Page 2 of 32_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
11/2023
7 WARNINGS AND PRECAUTIONS, Skin, Drug Rash with
Eosinophilia and Systemic Symptoms (DRESS)
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
........................................................................................2
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................4
1
INDICATIONS
..................................................................................................................4
1.1 Pediatrics
...................................................................................................................4
1.2 Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS
..................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................5
4
DOSAGE AND ADMINISTRATION
.................................................................................5
4.1 Dosing Considerations
...............................................................................................5
4.2 Recommended Dose and Dosage Adjustment
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