ALLOPURINOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALLOPURINOL

Available from:

APOTEX INC

ATC code:

M04AA01

INN (International Name):

ALLOPURINOL

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

ALLOPURINOL 300MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTIGOUT AGENTS

Product summary:

Active ingredient group (AIG) number: 0103654003; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-02-04

Summary of Product characteristics

_ALLOPURINOL (Allopurinol Tablets) _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALLOPURINOL
Allopurinol Tablets
Tablets, 300 mg, Oral
USP
ATC Code: M04AA01
Xanthine oxidase inhibitor
APOTEX INC.
Date of Initial Authorization:
150 Signet Drive
AUG 25, 2010
Toronto, Ontario
M9L 1T9
Date of Revision:
NOV 21, 2022
Submission Control Number: 265241
_ALLOPURINOL (Allopurinol Tablets) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
11/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
11/2022
7 Warnings and Precautions
11/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
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
.............................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
.....................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.5
Missed Dose
............................................................