Dulcolax Suppositories For Adults 10mg

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

Bisacodyl

Dostępny od:

DKSH MALAYSIA SDN BHD

INN (International Nazwa):

Bisacodyl

Sztuk w opakowaniu:

5units Units; 50units Units

Wyprodukowano przez:

ISTITUTO DE ANGELI S.R.L.

Ulotka dla pacjenta

DULCOLAX
® SUPPOSITORIES FOR ADULTS
Bisacodyl (10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Dulcolax Suppositories is
used for
2. How Dulcolax Suppositories works
3. Before you use Dulcolax
Suppositories
4. How to use Dulcolax
Suppositories
5. While you are using it
6. Side effects
7. Storage and Disposal of Dulcolax
Suppositories
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT DULCOLAX SUPPOSITORIES IS USED
FOR
Dulcolax Suppositories is used for relief
of constipation.
Dulcolax Suppositories is also used to
stimulate defaecation for diagnostic or
operation procedures.
HOW DULCOLAX SUPPOSITORIES WORKS
Dulcolax Suppositories is a laxative that
works by increasing the movement of the
intestines, helping the stool to come out.
BEFORE YOU USE DULCOLAX SUPPOSITORIES
-
_When you must not use it, if: _
Do not use Dulcolax Suppositories if
any of the below applies to you.
• you are allergic (hypersensitive) to
bisacodyl or any other ingredients of
this medicine (listed in Product
Description)
• you have severe dehydration
• you have a bowel condition called
“ileus” (lack of function in the
intestine)
• you have a 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
• you have cracking of the skin around
your back passage (anal fissures)
• you have inflammation or ulcers
around your back passage (ulcerative
proctitis)
If
you
are
not
sure,
talk
to
your
pharmacist or doctor before using this
medicine.
-
_ Before you start use it _
Stimulant laxatives including Dulcolax
do not help with weight loss.
_ _
_ _
_Pregnancy and lactation_
Please consult your doctor or pharmacist
if
you
are
pregnant,
planning
for
pregnancy or breast-feeding before using
any medicine.
-
_ Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy
wi

Charakterystyka produktu

COMPOSITION
1 paediatric suppository contains
5 mg
1 suppository contains
10 mg
4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane
(= bisacodyl)
PRODUCT DESCRIPTIONS
Dulcolax Suppositories 5mg for children:
Smooth, white, torpedo-shaped suppositories
with a ‘chimney’ in the base.
Dulcolax Suppositories 10mg for adults: White
or slightly yellowish, torpedo-shaped
suppositories with a smooth or slightly
unctuous surface and a “chimney” in the base.
PHARMACOLOGICAL PROPERTIES
ATC code: A06AB02
Bisacodyl is a locally acting laxative from the
diphenylmethane derivatives group having
a dual action. As a contact laxative, for which
also antiresorptive hydragogue effects have
been described, bisacodyl stimulates after
hydrolysis in the large intestine, the mucosa of
both the large intestine and of the rectum.
Stimulation of the mucosa of the large intestine
results in colonic peristalsis with promotion of
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.
Stimulation of the rectum causes increased
motility and a feeling of rectal fullness. The
rectal effect may help to restore the “call to
stool” although its clinical relevance remains
to be established.
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
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