SANDOMIGRAN DS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PIZOTIFEN (PIZOTIFEN MALATE)

Available from:

PALADIN LABS INC.

ATC code:

N02CX01

INN (International Name):

PIZOTIFEN

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

PIZOTIFEN (PIZOTIFEN MALATE) 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTIMIGRAINE AGENTS, MISCELLANEOUS

Product summary:

Active ingredient group (AIG) number: 0110877001; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-06-02

Summary of Product characteristics

_Product Monograph _
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SANDOMIGRAN DS (_pizotifen tablets)_
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_ Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOMIGRAN DS
Pizotifen tablets
Tablets, 1 mg pizotifen (as pizotifen malate), oral
Serotonin and Tryptamine Antagonist
Migraine Prophylaxis
ATC code: N02CX
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
Date of Initial Authorization:
December 31, 1980
Date of Revision:
August 23, 2023
Version 5.0
Submission Control Number: 272965
_Product Monograph _
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SANDOMIGRAN DS (_pizotifen tablets)_
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_ Page 2 of 21_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.5
Missed Dose
..............................................