CIMETIDINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIMETIDINE

Available from:

AA PHARMA INC

ATC code:

A02BA01

INN (International Name):

CIMETIDINE

Dosage:

800MG

Pharmaceutical form:

TABLET

Composition:

CIMETIDINE 800MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0111925006; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-01-22

Summary of Product characteristics

_CIMETIDINE (Cimetidine) _
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CIMETIDINE
Cimetidine
Tablet, 200, 300, 400, 600 and 800 mg, oral
USP
ATC Code: A02BA01
Histamine H
2
- Antagonist
AA PHARMA INC
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
DEC 31, 1982
Date of Revision:
FEB 10, 2022
Submission Control Number: 256184
_CIMETIDINE (Cimetidine) _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
02/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing considerations
..........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.5
Missed Dose
........................................................................................................6
5
OVERDOSAGE
...............................................................................................................6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
...................................7
7
WARNINGS AND PRECAUTIONS
......................................