Land: Canada
Taal: Engels
Bron: Health Canada
IBUPROFEN; METHOCARBAMOL
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M03BA53
METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS
200MG; 500MG
TABLET
IBUPROFEN 200MG; METHOCARBAMOL 500MG
ORAL
18/24/40/50/60
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0248961001; AHFS:
APPROVED
2003-04-02
_GlaxoSmithKline Consumer Healthcare Inc. _ _Page 1 of 36_ PRODUCT MONOGRAPH ROBAX PLATINUM Methocarbamol and Ibuprofen Caplets 500 mg/200 mg Muscle Relaxant/Analgesic GlaxoSmithKline Consumer Healthcare Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Preparation: Dec 16, 2003 Date of Revision: April 3, 2020 Submission Control No: 236559 _ _ _GlaxoSmithKline Consumer Healthcare Inc. _ _Page 2 of 36_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY ..........................................................................................20 SPECIAL HANDLING INSTRUCTIONS .......................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................20 PART II: SCIENTIFIC INFORMATION ...............................................................................21 PHARMACEUTICAL INFORMATION ..........................................................................21 CLINICAL TRIALS .......................................................................... Lees het volledige document