TAGAMET PREVENT TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIMETIDINE

Available from:

MEDTECH PRODUCTS INC

ATC code:

A02BA01

INN (International Name):

CIMETIDINE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

CIMETIDINE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0111925005; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-04-06

Summary of Product characteristics

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_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TAGAMET® PREVENT
Cimetidine Tablets
Tablet, 200 mg, Oral
USP
Histamine H
2
– Receptor Antagonist
ATC Code: A02BA01
Medtech Products Inc.
660 White Plains Rd., Suite 250
Tarrytown, NY 10591
USA
Date of Initial Authorization:
Apr 12, 2000
Date of Revision:
Mar 22, 2023
Submission Control Number: 270508
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_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
None.
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.5
Missed Dose
...........................................................................................................
5
5
OVERDOSAGE
................................................