IMODIUM COMPLETE CHEWABLE TABLETS TABLET (CHEWABLE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

MAH:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC_code:

A07DA53

INN:

LOPERAMIDE, COMBINATIONS

dosage:

2MG; 125MG

pharmaceutical_form:

TABLET (CHEWABLE)

composition:

LOPERAMIDE HYDROCHLORIDE 2MG; SIMETHICONE 125MG

administration_route:

ORAL

units_in_package:

5/10/20

prescription_type:

OTC

therapeutic_area:

ANTIDIARRHEA AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0231812001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2014-05-21

SPC

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_ IMODIUM_
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PRODUCT MONOGRAPH
IMODIUM
®
Complete
Loperamide Hydrochloride, 2 mg/ Simethicone, 125 mg
Oral antidiarrheal/antiflatulent agent
McNeil Consumer Healthcare,
Division of Johnson & Johnson Inc.
88 McNabb St.
Markham, Ontario
L3R 5L2
Date of Revision:
May 22, 2019
Submission Control No: 225986
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_ IMODIUM_
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_ Complete _
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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
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
..................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 10
STORAGE AND STABILITY
.........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 11
PART II: SCIENTIFIC INFORMATION
..............................................................................
12
PHARMACEUTICAL INFORMATION
.........................................................................
12
CLINICAL TRIALS
...........................................................................................