IMODIUM - CAPLET 2MG TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

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Productkenmerken Productkenmerken (SPC)
29-05-2018

Werkstoffen:

LOPERAMIDE HYDROCHLORIDE

Beschikbaar vanaf:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC-code:

A07DA03

INN (Algemene Internationale Benaming):

LOPERAMIDE

Dosering:

2MG

farmaceutische vorm:

TABLET

Samenstelling:

LOPERAMIDE HYDROCHLORIDE 2MG

Toedieningsweg:

ORAL

Eenheden in pakket:

6/12/24/42

Prescription-type:

OTC

Therapeutisch gebied:

ANTIDIARRHEA AGENTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2014-05-06

Productkenmerken

                                _IMODIUM_
_®_
_ _
_ _
_McNeil Consumer Healthcare _
_Loperamide Hydrochloride _
_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
IMODIUM
®
Caplets
(Loperamide Hydrochloride Tablets, 2 mg)
and
IMODIUM
®
Quick-Dissolve
(Loperamide Hydrochloride Tablets, 2 mg)
and
IMODIUM
®
Calming Liquid
(Loperamide Hydrochloride Oral Solution, 2 mg/15 mL)
and
IMODIUM
®
LIQUI-GELS
®
(Loperamide Hydrochloride Capsules, 2 mg)
Oral antidiarrheal agent
McNeil Std
A07 DA03
_ _
_ _
McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Preparation:
January 18, 2007
Date of Revision:
May 29, 2018
Control # 213956
®LIQUI-GELS is a registered trademark of Catalent Pharma Solutions,
Inc. used under licence
_IMODIUM_
_®_
_ _
_ _
_McNeil Consumer Healthcare _
_Loperamide Hydrochloride _
_ _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................
                                
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