Dulcolax Tablet 5mg

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

Bisacodyl

Disponibbli minn:

DKSH MALAYSIA SDN. BHD.

INN (Isem Internazzjonali):

Bisacodyl

Unitajiet fil-pakkett:

30Tablet Tablets; 200Tablet Tablets; 30 Tablets; 200 Tablets

Manifatturat minn:

Delpharm Reims

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DULCOLAX TABLET
®
Bisacodyl (5mg)
1
WHAT IS IN THIS LEAFLET
1.
What DULCOLAX Tablet is used
for
2.
How DULCOLAX Tablet works
3.
Before you use DULCOLAX
Tablet
4.
How to use DULCOLAX Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DULCOLAX Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DULCOLAX TABLET IS USED
FOR
DULCOLAX Tablets contain a
medicine called bisacodyl. This
belongs to a group of medicines called
laxatives.
•
DULCOLAX Tablets are used for
relief of constipation
•
DULCOLAX Tablets are also used
in preparation of diagnostic
procedures, in pre- and
postoperative treatment and in
conditions, which require defecation
to be facilitated
HOW DULCOLAX TABLET WORKS
DULCOLAX Tablets are laxative that
acts in stimulation of defecation,
reduction of transit time, and softening
of the stool. This specifically
stimulates the natural evacuation
process in the lower region of the
gastrointestinal tract.
BEFORE YOU USE DULCOLAX TABLET
_-When you must not use it, _
if:
•
You are allergic (hypersensitive) to
bisacodyl or any of the other
ingredients in the product (listed in
Product Description section)
•
You have severe dehydration
•
You have a bowel condition called
“ileus” (blockage in the intestine)
•
You have acute abdominal condition
such as appendicitis
•
You have severe abdominal pain
with nausea and vomiting
•
You have a blocked bowel
(intestinal obstruction)
•
You have inflammation of the
bowel
Do not take this medicine if any of the
above applies to you. If you are not
sure, talk to your pharmacist or doctor
before using this medicine.
_Pregnancy and lactation _
Talk to your pharmacist or doctor
before using DULCOLAX Tablets if
you are pregnant or planning to
become pregnant. DULCOLAX
Tablets should not be taken in
pregnancy and breast feeding unless
the expected benefit is thought to
outweigh any possible risk and as
advised by your prescriber.
_-Before

Karatteristiċi tal-prodott

COMPOSITION
1 coated tablet contains
5 mg
4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane
(= bisacodyl)
PRODUCT DESCRIPTION
Round, beige yellow biconvex, sugar/enteric-
coated tablets with a smooth, shiny surface
and a white core.
PHARMACOLOGICAL PROPERTIES
ATC code: A06AB02
Bisacodyl is a locally acting laxative from the
diphenylmethane derivatives group. As a contact
laxative, for which also antiresorptive hydragogue
effects have been described, bisacodyl
stimulates, after hydrolysis in the large
intestine, peristalsis of the colon and promotes
accumulation of water, and consequently
electrolytes, in the colonic lumen. This results
in a stimulation of defecation, reduction of
transit time and softening of the stool.
As a laxative that acts on the colon, bisacodyl
specifically stimulates the natural evacuation
process in the lower region of the
gastrointestinal tract. Therefore, bisacodyl is
ineffective in altering the digestion or
absorption of calories or essential nutrients in
the small intestine.
PHARMACOKINETICS
Following either oral or rectal administration,
bisacodyl is rapidly hydrolyzed to the active
principle bis-(p-hydroxyphenyl)-pyridyl-2-
methane (BHPM), mainly by esterases of the
enteric mucosa.
Administration as an enteric coated tablet was
found to result in maximum BHPM plasma
concentrations between 4 - 10 hours post
administration whereas the laxative effect
occurred between 6 - 12 hours post
administration. In contrast, following the
administration as a suppository, the laxative
effect occurred on average approximately
20 minutes post administration; in some cases
it occurred 45 minutes after administration.
The maximum BHPM-plasma concentrations
were achieved 0.5 - 3 hours following the
administration as a suppository. Hence, the
laxative effect of bisacodyl does not correlate
with the plasma level of BHPM. Instead, BHPM
acts locally in the lower part of the intestine
and there is no relationship between the
laxative effect and plasma levels of the active
moiety. For this reason, bisacodyl coat