DULCOLAX SUPPOSITORY

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BISACODYL

Saatavilla:

SANOFI CONSUMER HEALTH INC

ATC-koodi:

A06AB02

INN (Kansainvälinen yleisnimi):

BISACODYL

Annos:

10MG

Lääkemuoto:

SUPPOSITORY

Koostumus:

BISACODYL 10MG

Antoreitti:

RECTAL

Kpl paketissa:

3/6/100

Prescription tyyppi:

OTC

Terapeuttinen alue:

CATHARTICS AND LAXATIVES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0101506002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-12-09

Valmisteyhteenveto

_ _
_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
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_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