Country: Canada
Language: English
Source: Health Canada
GABAPENTIN
PHARMASCIENCE INC
N02BF01
GABAPENTIN
600MG
TABLET
GABAPENTIN 600MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929004; AHFS:
APPROVED
2004-07-28
PRODUCT MONOGRAPH Pr PMS-GABAPENTIN Gabapentin Capsules, House Standard 100 mg, 300 mg and 400 mg Gabapentin Tablets, USP 600 mg and 800 mg Antiepileptic Agent PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com DATE OF REVISION: May 27, 2020 Submission Control No: 238470 _pms-GABAPENTIN Product Monograph _ _Page 2 of 33_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY ............................................................18 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ................................................................................22 PHARMACEUTICAL INFORMATION ..........................................................................22 CLINICAL TRIALS ..........................................................................................................23 DETA Read the complete document