מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
BISACODYL
SANOFI CONSUMER HEALTH INC
A06AB02
BISACODYL
10MG
SUPPOSITORY
BISACODYL 10MG
RECTAL
3/6/100
OTC
CATHARTICS AND LAXATIVES
Active ingredient group (AIG) number: 0101506002; AHFS:
APPROVED
2019-12-09
_ _ _Dulcolax Prescribing Information _ _Page 1 of 12 _ PRESCRIBING INFORMATION DULCOLAX ® Bisacodyl Tablets 5 mg Suppositories 10 mg Manufacturer’s Standard Stimulant Laxative sanofi-aventis Canada Inc. 2905 Louis-R.-Renaud Place Laval, Quebec H7V 0A3 Date of Revision: November 7, 2017 Submission Control No:210082 CCDS: 0074-07 _ _ _Dulcolax Prescribing Information _ _Page 2 of 12 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION .....................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ...............................................................................4 ADVERSE REACTIONS ....................................................................................................5 DOSAGE AND ADMINISTRATION ................................................................................6 OVERDOSAGE ..................................................................................................................7 STORAGE AND STABILITY ............................................................................................7 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................8 PART III: CONSUMER INFORMATION................................................................................9 PART III: CONSUMER INFORMATION..............................................................................11 _ _ _Dulcolax Prescribing Information _ _Page 3 of 12 _ DULCOLAX ® Bisacodyl PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Oral tablet 5 mg acacia, white wax, carnauba wax, corn starch (dried/soluble), methacry קרא את המסמך השלם