DULCOLAX FOR WOMEN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

BISACODYL

Verfügbar ab:

SANOFI CONSUMER HEALTH INC

ATC-Code:

A06AB02

INN (Internationale Bezeichnung):

BISACODYL

Dosierung:

5MG

Darreichungsform:

TABLET

Zusammensetzung:

BISACODYL 5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

OTC

Therapiebereich:

CATHARTICS AND LAXATIVES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0101506001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2020-09-15

Fachinformation

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_Page 1 of 9 _
PRESCRIBING INFORMATION
DULCOLAX FOR WOMEN
®
Bisacodyl Tablets USP 5mg
Stimulant Laxative
sanofi-aventis Canada Inc.
2905 Louis-R.-Renaud Place
Laval, Quebec H7V 0A3
Date of Revision:
January 25, 2019
Submission Control No: 217502
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_Page 2 of 9 _
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
...............................................7
PART III: CONSUMER
INFORMATION................................................................................8
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_Page 3 of 9 _
DULCOLAX
®
FOR WOMEN
Bisacodyl
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Oral
tablet 5 mg
acacia, ammonium hydroxide, carnauba wax, corn
starch, D&C Red #27 aluminum lake, FD&C Blue #2
aluminum lake, FD&C Yellow #6 aluminum lake,
iron oxide black, glycerin, glyceryl monostearate,
lactose monohydrate, magnesium stearate, methacrylic
acid and ethyl acrylate copolymer, methylparaben,
modified s