ADVIL HEADACHE CAPLETS TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Dostupno od:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

ATC koda:

M01AE01

INN (International ime):

IBUPROFEN

Doziranje:

200MG

Farmaceutski oblik:

TABLET

Sastav:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 200MG

Administracija rute:

ORAL

Jedinice u paketu:

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

Tip recepta:

OTC

Područje terapije:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2018-08-02

Svojstava lijeka

_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
HEADACHE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.
450 – 55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Submission Control No.: 206535
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.............................................