DULCOLAX

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

BISACODYL

Available from:

AVENTIS PHARMA - Indonesia

INN (International Name):

BISACODYL

Dosage:

10 MG

Pharmaceutical form:

SUPPOSITORIA

Units in package:

DUS, 10 STRIP @ 5 SUPPOSITORIA DEWASA

Manufactured by:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

Authorization date:

2019-02-07

Summary of Product characteristics

COMPANY CORE DATA SHEET
No. 0074-08
_ _
DULCOLAX
®
COMPOSITION
1 suppository contains
10 mg
1 paediatric suppository contains
5 mg
4,4'-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl)
Excipients:**
Suppositories:
hard fat Witepsol W 45
INDICATIONS
For use in patients suffering from constipation.
For preparation of diagnostic procedures, in pre- and postoperative
treatment and in conditions which require
defecation to be facilitated.
DOSAGE AND ADMINISTRATION
Unless otherwise prescribed by the physician, the following dosages
are recommended:
For constipation
suppositories
Adults and children over 10 years:
1 suppository (10 mg) daily
Paediatric population:
Children 6 - 10 years:
1 suppository (5 mg) daily
Children aged 10 years or younger with chronic or persistent
constipation should only be treated under the
guidance of a physician.
Instructions for use:
Suppositories are usually effective in about 20 minutes (usual range
10 to 30 minutes). Rarely the laxative effect
has been reported 45 minutes after administration.
They should be unwrapped and inserted into the rectum pointed end
first.
For preparation of diagnostic procedures and preoperatively
For preparation of diagnostic procedures, in pre- and postoperative
treatment and in medical conditions which
require defecation to be facilitated, DULCOLAX
®
should be used under medical supervision.
In order to achieve complete evacuation of the intestine the DULCOLAX
®
dosage recommended for adults is
two to four coated tablets the night before the examination, followed
by one suppository in the morning of the
examination.
Paediatric population
For children 6 years of age and over, one coated tablet in the evening
and one paediatric suppository on the
following morning is recommended.
CHILDREN UNDER 6 YEARS:
Chhildren under 6 years should not take DULCOLAX
®
without medical advice.
DISETUJUI OLEH BPOM: 23/08/2021
ID REG: EREG10002212100138 - EREG10002212100140
CONTRAINDICATIONS
DULCOLAX
®
is contraindicated in patients with ileus, intestinal obstruction,