IBUPROFEN + PSEUDOEPHEDRINE CAPLETS TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
25-08-2016
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ingredients actius:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Disponible des:
MARCAN PHARMACEUTICALS INC
Codi ATC:
M01AE51
Designació comuna internacional (DCI):
IBUPROFEN, COMBINATIONS
Dosis:
200MG; 30MG
formulario farmacéutico:
TABLET
Composición:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
Vía de administración:
ORAL
Unidades en paquete:
10/24/100
tipo de receta:
OTC
Área terapéutica:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0222394001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2016-08-23
Fitxa tècnica
Page 1 of 47
PRODUCT MONOGRAPH
IBUPROFEN + PSEUDOEPHEDRINE CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Marcan Pharmaceuticals Inc.
Date of Preparation:
77 Auriga Drive, Unit #4
August 23, 2016
Ottawa, Ontario
K2E 7Z7
Control# 197421
Page 2 of 47
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................................
5
ADVERSE REACTIONS
....................................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................................
20
OVERDOSAGE
...................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
22
STORAGE AND STABILITY
............................................................................................................
26
SPECIAL HANDLING INSTRUCTION
............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................................
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