Страна: Канада
Език: английски
Източник: Health Canada
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
A07DA53
LOPERAMIDE, COMBINATIONS
2MG; 125MG
TABLET
LOPERAMIDE HYDROCHLORIDE 2MG; SIMETHICONE 125MG
ORAL
2/5/10/20/40/42
OTC
ANTIDIARRHEA AGENTS
Active ingredient group (AIG) number: 0231812001; AHFS:
APPROVED
2002-02-06
_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................................................ Прочетете целия документ