OCTASA TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MESALAZINE

Available from:

TILLOTTS PHARMA AG

ATC code:

A07EC02

INN (International Name):

MESALAZINE

Dosage:

800MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

MESALAZINE 800MG

Administration route:

ORAL

Units in package:

20/180

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0116808010; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-05-18

Summary of Product characteristics

_Octasa_
_® _
_(Mesalamine Delayed-Release Tablets) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCTASA®
Mesalamine * Delayed-Release Tablets
Tablets (delayed-release), 800 mg, Oral use
Mfr. Std.
Intestinal Anti-inflammatory Agent
Tillotts Pharma AG
Baslerstrasse 15, CH-4310 Rheinfelden
Switzerland
Importer/Distributor:
C.R.I.
Burlington, ON
L7N 3G2
Date of Initial Authorization:
May 18, 2021
Date of Revision:
October 25, 2023
Submission Control Number: 275820
Octasa® is a trademark of Tillotts Pharma AG, Rheinfelden,
Switzerland.
* also known as 5-aminosalicylic acid (5-ASA) or Mesalazine
_Octasa_
_®_
_ (Mesalamine Delayed-Release Tablets) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
10/2023
7 WARNINGS AND PRECAUTIONS, Skin
10/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
......