PMS-LOPERAMIDE - CAPLET 2MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LOPERAMIDE HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

A07DA03

INN (International Name):

LOPERAMIDE

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

LOPERAMIDE HYDROCHLORIDE 2MG

Administration route:

ORAL

Units in package:

100/500 CAPLETS

Prescription type:

OTC

Therapeutic area:

ANTIDIARRHEA AGENTS

Product summary:

Active ingredient group (AIG) number: 0111332001; AHFS:

Authorization status:

MARKETED

Authorization date:

1996-09-12

Summary of Product characteristics

_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 1 of 38 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PMS-LOPERAMIDE
Loperamide Hydrochloride Tablets
Caplet, 2 mg, oral
USP
and
PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION
Loperamide Hydrochloride Oral Solution
Solution, 0.2 mg / mL, Oral
USP
Antidiarrheal agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
pms-LOPERAMIDE HYDROCHLORIDE SOLUTION:
June 2, 1993
pms-LOPERAMIDE
August 2, 1996
Date of Revision:
June 26, 2023
Submission Control Number: 272133
_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 2 of 38 _
_ _
RECENT MAJOR LABEL CHANGES
5 OVERDOSAGE, Addition of drug withdrawal syndrome
06/2022
7 WARNINGS AND PRECAUTIONS, Addition of drug withdrawal syndrome
06/2022
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
4
DOSAGE AND ADMINISTRATION
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