PEPCID COMPLETE TABLET (CHEWABLE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE

Tilgjengelig fra:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC-kode:

A02BA53

INN (International Name):

FAMOTIDINE, COMBINATIONS

Dosering :

10MG; 800MG; 165MG

Legemiddelform:

TABLET (CHEWABLE)

Sammensetning:

FAMOTIDINE 10MG; CALCIUM CARBONATE 800MG; MAGNESIUM HYDROXIDE 165MG

Administreringsrute:

ORAL

Enheter i pakken:

5/25/50/80

Resept typen:

OTC

Terapeutisk område:

ANTACIDS AND ADSORBENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0341105001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2011-12-06

Preparatomtale

_Product Monograph Master Template _
_Template Date: September 2020 _
_PEPCID_
_®_
_ COMPLETE_
_®_
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_Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets
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_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
......................................................