IBUPROFEN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-02-2020
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Active ingredient:
IBUPROFEN
Available from:
ANGITA PHARMA INC.
ATC code:
M01AE01
INN (International Name):
IBUPROFEN
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
IBUPROFEN 200MG
Administration route:
ORAL
Units in package:
100
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0108883004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-04-23
Summary of Product characteristics
_Page 1 / 40_
PRODUCT MONOGRAPH
IBUPROFEN
Ibuprofen Tablets USP
200mg and 400 mg
Non-Steroidal Anti-inflammatory Drug
Analgesic, Antipyretic Agent
Angita Pharma Inc.
1310 Nobel Street,
Boucherville,
Québec Canada, J4B 5H3
Date of Preparation: February 26, 2020
Control # 236574
_Page 2 / 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINCAL USE
...........................................................................................
3
CONTRAINDICATIONS
...............................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
................................................................................................................
9
DRUG INTERACTIONS
..............................................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................................
15
OVERDOSAGE
..................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
16
STORAGE AND STABILITY
......................................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 18
PART II: SCIENTIFIC INFORMATION
................................................................................
19
PHARMACEUTICAL INFORMATION
..................
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