ADVIL HEADACHE & MIGRAINE CAPLETS TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Commercializzato da:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Codice ATC:

M01AE01

INN (Nome Internazionale):

IBUPROFEN

Dosaggio:

200MG

Forma farmaceutica:

TABLET

Composizione:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 200MG

Via di somministrazione:

ORAL

Confezione:

10/16//20/40/55/120/150/325/350

Tipo di ricetta:

OTC

Area terapeutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0108883004; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-07-16

Scheda tecnica

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_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 66 _
PRODUCT MONOGRAPH
ADVIL
®
HEADACHE & MIGRAINE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE & MIGRAINE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE & MIGRAINE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
Canada L5N 6L4
Submission Control No.: 240099
Date of Preparation:
May 12, 2015
Date of Revision :
July 10, 2020
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_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 66 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSA