EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

IBUPROFEN

Disponible desde:

APOTEX INC

Código ATC:

M01AE01

Designación común internacional (DCI):

IBUPROFEN

Dosis:

400MG

formulario farmacéutico:

CAPSULE

Composición:

IBUPROFEN 400MG

Vía de administración:

ORAL

Unidades en paquete:

12/16/24/50/100/144/165/180

tipo de receta:

OTC

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0108883002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2008-05-22

Ficha técnica

Page 1 of 45
PRODUCT MONOGRAPH
IBUPROFEN LIQUID FILLED CAPSULES
Ibuprofen Capsules
200 mg
EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES
Ibuprofen Capsules
400 mg
Analgesic/Antipyretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
May 27, 2020
Submission Control Number: 240415
Page 2 of 45
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
......................................................................................................................................
11
DRUG INTERACTIONS
......................................................................................................................................
14
DOSAGE AND ADMINISTRATION
..................................................................................................................
17
OVERDOSAGE
.....................................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................................
19
STORAGE AND STABILITY
..............................................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
....................................................