Land: Kanada
Språk: engelska
Källa: Health Canada
FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
A02BA53
FAMOTIDINE, COMBINATIONS
10MG; 800MG; 165MG
TABLET (CHEWABLE)
FAMOTIDINE 10MG; CALCIUM CARBONATE 800MG; MAGNESIUM HYDROXIDE 165MG
ORAL
5/25/50/80
OTC
ANTACIDS AND ADSORBENTS
Active ingredient group (AIG) number: 0341105001; AHFS:
APPROVED
2011-12-06
_Product Monograph Master Template _ _Template Date: September 2020 _ _PEPCID_ _®_ _ COMPLETE_ _®_ _ _ _Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets _ _Page 1 of 30_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PEPCID® COMPLETE® Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets 10 mg Famotidine / 800 mg Calcium Carbonate / 165 mg Magnesium Hydroxide Combination Histamine H 2 -Receptor Antagonist and Antacid McNeil Consumer Healthcare Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Ontario L3R 5L2 Date of Initial Authorization: June 12, 2000 Date of Revision: June 15, 2023 Submission Control Number: 269619 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _PEPCID_ _®_ _ COMPLETE_ _®_ _ _ _Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets _ _Page 2 of 30_ RECENT MAJOR LABEL CHANGES Section 7: Warnings and Precautions – Information added regarding driving and operating machinery, as well as regarding pregnancy and breast-feeding 11/2022 Section 8: Adverse Reactions – New information regarding clinical and post-market adverse reactions added 11/2022 Section 9: Drug Interactions – Drug interactions regarding minerals and thiazide diuretics added. Information on ciprofloxacin replaced with information on the overarching fluoroquinolone class of drugs. 11/2022 Section 16: Non-Clinical Toxicology – Addition of toxicology information for antacid ingredients 11/2022 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 ...................................................... Läs hela dokumentet