IMODIUM COMPLETE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Διαθέσιμο από:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Φαρμακολογική κατηγορία (ATC):

A07DA53

INN (Διεθνής Όνομα):

LOPERAMIDE, COMBINATIONS

Δοσολογία:

2MG; 125MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

LOPERAMIDE HYDROCHLORIDE 2MG; SIMETHICONE 125MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

2/5/10/20/40/42

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

ANTIDIARRHEA AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2002-02-06

Αρχείο Π.Χ.Π.

_Product Monograph Master Template _
_Template Date: September 2020 _
_IMODIUM_
_®_
_ Complete _
_Loperamide Hydrochloride / Simethicone Tablets _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMODIUM
® COMPLETE
Loperamide Hydrochloride / Simethicone Tablets
2 mg Loperamide Hydrochloride / 125 mg Simethicone
Oral antidiarrheal / antiflatulent agent
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Initial Authorization:
February 6, 2002
Date of Revision:
May 2, 2022
Submission Control Number: 259265
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_IMODIUM_
_®_
_ Complete _
_Loperamide Hydrochloride / Simethicone Tablets _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
Section 6: Dosage Forms, Strengths, Composition and
Packaging – Addition of 40-count blister packs and removal
of 42-count bottles
07/2020
Section 5: Overdosage – addition of drug withdrawal
syndrome
12/2021
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
4
DOSAGE AND
ADMINISTRATION................................................