SUVEXX TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE); NAPROXEN SODIUM

Available from:

ARALEZ PHARMACEUTICALS CANADA INC

ATC code:

N02CC51

INN (International Name):

SUMATRIPTAN AND NAPROXEN

Dosage:

85MG; 500MG

Pharmaceutical form:

TABLET

Composition:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 85MG; NAPROXEN SODIUM 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0262035001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-02-27

Summary of Product characteristics

_SUVEXX_
®
_ Product Monograph _
_(sumatriptan/naproxen sodium) tablets _
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SUVEXX
®
sumatriptan/naproxen sodium tablets
85 mg sumatriptan (as sumatriptan succinate) / 500 mg naproxen sodium
Serotonin (5-HT
1B/1D
) receptor agonist (triptan) / Non-Steroidal Anti-Inflammatory Drug
(NSAID)
Aralez Pharmaceuticals Canada Inc.*
6733 Mississauga Road, Suite 800
Mississauga, Ontario
Canada L5N 6J5
www.miravohealthcare.com
Date of Initial Approval:
February 26, 2020
Date of Revision:
December 20, 2021
Submission Control No: 253456
*Doing business as (d/b/a) Miravo Healthcare
_ _
_SUVEXX_
®
_ Product Monograph _
_(sumatriptan/naproxen sodium) tablets _
_ _
_ _
_Page 2 of 45_
TABLE OF CONTENTS
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
.............................................. 6
4
DOSAGE AND ADMINISTRATION
.........................................................................
7
4.1
General
.............................................................................................................
7
4.2
Dosing
Considerations.....................................................................................
7
4.3
Recommended Dose and Dosage Adjustment
.............................................. 7
4.4
Administration...........................