IBUPROFEN + PSEUDOEPHEDRINE CAPLETS TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Commercializzato da:

MARCAN PHARMACEUTICALS INC

Codice ATC:

M01AE51

INN (Nome Internazionale):

IBUPROFEN, COMBINATIONS

Dosaggio:

200MG; 30MG

Forma farmaceutica:

TABLET

Composizione:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

Via di somministrazione:

ORAL

Confezione:

10/24/100

Tipo di ricetta:

OTC

Area terapeutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0222394001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-08-23

Scheda tecnica

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
...............................................................