PREGABALIN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PREGABALIN

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

N02BF02

INN (International Name):

PREGABALIN

Dosage:

50MG

Pharmaceutical form:

CAPSULE

Composition:

PREGABALIN 50MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0151121002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-10-06

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PREGABALIN
Pregabalin Capsules
Capsules, 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg, Oral
House Standard
Analgesic Agent
SIVEM PHARMACEUTICALS ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control Number: 279604
_ _
Date of Initial Authorization:
MAR
26, 2013
Date of
Revision:
OCT 23, 2023
_PREGABALIN (Pregabalin Capsules) _
_Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence, Abuse Potential or Misuse
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1. Pregnant Women
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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