Maa: Kanada
Kieli: englanti
Lähde: Health Canada
FAMOTIDINE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
A02BA03
FAMOTIDINE
10MG
TABLET
FAMOTIDINE 10MG
ORAL
18/30/60
OTC
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0118722003; AHFS:
APPROVED
2011-12-02
_PEPCID AC_ _®_ _Page 1 of 18_ PRODUCT MONOGRAPH PEPCID AC ® famotidine tablets FILM COATED TABLETS 10 MG Mfr. Std. HISTAMINE H 2 RECEPTOR ANTAGONIST McNeil Consumer Healthcare, division of Johnson & Johnson Inc. 88 McNabb Street Markham, Ontario L3R 5L2 Date of Preparation: February 14, 1996 Date of Revision: May 24, 2019 Submission Control No: 225990 _PEPCID AC_ _®_ _Page 2 of 18_ _PEPCID AC_ _®_ _Page 3 of 18_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION .........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ....................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................3 ADVERSE REACTIONS ....................................................................................................4 DRUG INTERACTIONS ....................................................................................................5 DOSAGE AND ADMINISTRATION ................................................................................5 OVERDOSAGE ...................................................................................................................6 ACTION AND CLINICAL PHARMACOLOGY ...............................................................6 STORAGE AND STABILITY ............................................................................................8 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................8 PART II: SCIENTIFIC INFORMATION................................................................................12 PHARMACEUTICAL INFORMATION ..........................................................................12 CLINICAL TRIALS ....................................................... Lue koko asiakirja