FLUNARIZINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUNARIZINE (FLUNARIZINE HYDROCHLORIDE)

Available from:

AA PHARMA INC

ATC code:

N07CA03

INN (International Name):

FLUNARIZINE

Dosage:

5MG

Pharmaceutical form:

CAPSULE

Composition:

FLUNARIZINE (FLUNARIZINE HYDROCHLORIDE) 5MG

Administration route:

ORAL

Units in package:

60/100

Prescription type:

Prescription

Therapeutic area:

PIPERAZINE DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0133140001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-06-02

Summary of Product characteristics

_ _
_FLUNARIZINE (flunarizine hydrochloride) _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FLUNARIZINE
Flunarizine Hydrochloride
Capsules, 5 mg, oral
Selective Calcium-Entry Blocker
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
August 8, 2002
Date of Revision:
February 15, 2022
Submission Control Number: 256197
_ _
_FLUNARIZINE (flunarizine hydrochloride) _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
None at time of authorization.
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
.............................................................................................................
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
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.5
Missed Dose
..............................................................................................................
5
5
OVERDOSAGE
.............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING