MEFENAMIC CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-04-2019
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Active ingredient:
MEFENAMIC ACID
Available from:
AA PHARMA INC
ATC code:
M01AG01
INN (International Name):
MEFENAMIC ACID
Dosage:
250MG
Pharmaceutical form:
CAPSULE
Composition:
MEFENAMIC ACID 250MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0102336001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-12-08
Summary of Product characteristics
Page 1 of 32
_ _
PRESCRIBING INFORMATION
PRODUCT MONOGRAPH
PR
MEFENAMIC
MEFENAMIC ACID CAPSULES
250 MG
USP
ANALGESIC
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
DATE OF REVISION:
April 10, 2019
CONTROL NO.: 226522
Page 2 of 32
_ _
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
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMA
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