ACT PAROXETINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Available from:

ACTAVIS PHARMA COMPANY

ATC code:

N06AB05

INN (International Name):

PAROXETINE

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 20MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0123131002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-10-21

Summary of Product characteristics

_ACT Paroxetine Page 1 of 55 _
PRODUCT MONOGRAPH
PR
ACT PAROXETINE
Paroxetine tablets BP
10 mg, 20 mg & 30 mg
Paroxetine (as Paroxetine Hydrochloride Hemihydrate)
Antidepressant / Antiobsessional / Antipanic /
Anxiolytic Agent / Social Phobia (Social Anxiety Disorder) /
Posttraumatic Stress Disorder Therapy
Actavis Pharma Company Date of Revision:
6733 Mississauga Road, Suite 400
June 13, 2017
Mississauga, Ontario
L5N 6J5
Submission Control No: 206032
_ACT Paroxetine Page 2 of 55 _
TABLE OF CONTENTS
PART I:
HEALTH PROFESSIONAL INFORMATION.......………..............
3
SUMMARY PRODUCT INFORMATION .....................….............
3
INDICATIONS AND CLINICAL USE .....................……..............
3
CONTRAINDICATIONS
..........................................………...........
5
WARNINGS AND PRECAUTIONS
..........................……..............
6
ADVERSE REACTIONS
.....................................………….............
13
DRUG INTERACTIONS
..............................……………................
24
DOSAGE AND ADMINISTRATION .............…............................
29
OVERDOSAGE
.......................................………….........................
32
ACTION AND CLINICAL PHARMACOLOGY…..........................
33
STORAGE AND STABILITY
........................................……..........
35
DOSAGE FORMS, COMPOSITION AND PACKAGING…….......
35
PART II:
SCIENTIFIC INFORMATION
..........................…………….….......
37
PHARMACEUTICAL INFORMATION .........................….............
37
CLINICAL TRIALS
...............................................……………......
38
DETAILED PHARMACOLOGY ..............................……………..
41
TOXICOLOGY
.............................…………………………............
43
REFERENCES
.....................................………………………….....
45
PART III:
CONSUMER
INFORMATION.....................…………………..........
50
_ACT Paroxetine Page 3 of 55 _
PR
ACT PAROXETINE
Paroxetin