ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZOLMITRIPTAN

Available from:

SANIS HEALTH INC

ATC code:

N02CC03

INN (International Name):

ZOLMITRIPTAN

Dosage:

2.5MG

Pharmaceutical form:

TABLET (ORALLY DISINTEGRATING)

Composition:

ZOLMITRIPTAN 2.5MG

Administration route:

ORAL

Units in package:

6

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AGONISTS

Product summary:

Active ingredient group (AIG) number: 0134381001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-07-31

Summary of Product characteristics

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_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan
2.5 mg Tablet
PR
ZOLMITRIPTAN ODT
Zolmitriptan
2.5 mg Orally Disintegrating Tablet
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Date of Revision:
August 21, 2020
Submission Control No.:
242166
L6Y 5S5
Brampton, Ontario
1 President’s Choice Circle
Sanis Health
Inc.
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_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
..................................................................