Land: Kanada
Språk: engelska
Källa: Health Canada
IBUPROFEN
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M01AE01
IBUPROFEN
200MG
CAPSULE
IBUPROFEN 200MG
ORAL
15G/50G
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883004; AHFS:
APPROVED
2019-02-04
_ _ _GlaxoSmithKline Consumer Healthcare Inc.. Page 1 of 39_ PRODUCT MONOGRAPH ADVIL ® MINI-GELS Ibuprofen Capsules 200 mg (free acid and potassium salt) Analgesic/Antipyretic GlaxoSmithKine Consumer Healthcare Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Preparation: February 26, 2004 Date of Revision : April 2, 2020 Submission Control No: 236621 _ _ _GlaxoSmithKline Consumer Healthcare Inc. Page 2 of 39_ 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 ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 SPECIAL HANDLING INSTRUCTIONS .......................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ................................................................................22 PHARMACEUTICAL INFORMATION ............................................. Läs hela dokumentet