ACT SUMATRIPTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-04-2020
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Active ingredient:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
N02CC01
INN (International Name):
SUMATRIPTAN
Dosage:
25MG
Pharmaceutical form:
TABLET
Composition:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 25MG
Administration route:
ORAL
Units in package:
6/100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0123238007; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-19
Summary of Product characteristics
_ _
ACT_ _SUMATRIPTAN_ _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
ACT SUMATRIPTAN
SUMATRIPTAN TABLETS BP
100 mg Sumatriptan
(as sumatriptan succinate)
5-HT
1
Receptor Agonist
Migraine Therapy
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
April 21, 2020
Control Number : 236226
_ _
ACT_ _SUMATRIPTAN_ _
_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
.........................................................................................................
19
DET
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