CONSIGEL POWDER FOR ORAL SOLUTION 3.5G

Country: Malaysia

Language: English

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

Active ingredient:

ISPAGHULA HUSK

Available from:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (International Name):

ISPAGHULA HUSK

Units in package:

10 sachets x 4.44 gm

Manufactured by:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
_____________________________________________________________________________________________________________________________
_
________________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET:
1.
What is Consigel used for
2.
How Consigel works
3.
Before you use Consigel
4.
How to use Consigel
5.
While you are using Consigel
6.
Side effects
7.
Storage and disposal of Consigel
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT IS CONSIGEL USED FOR
Consigel
is
recommended
for
the
relief
of
constipation,
including
constipation
in
pregnancy and the maintenance of regularity.
This product also helps for the management of
bowel function in patients with:
-
Colostomy
-
Ileostomy
-
Haemorrhoids (piles)
-
Anal fissure
-
Chronic
diarrhoea
associated
with
diverticular disease
-
Irritable bowel syndrome
-
Ulcerative colitis
HOW CONSIGEL WORKS
Consigel contains ispaghula husk (or psyllium
husk) which is a natural fibre/ bulk laxative that
helps to relieve constipation. It absorbs water in
the gastrointestinal tract to form a mucilaginous
mass which increases the volume of faeces and
hence promotes peristalsis (muscle contractions)
in the digestive tract.
BEFORE YOU USE CONSIGEL
_When you must not to use it _
Do not use Consigel if you:
•
have pre-existing faecal impaction (excessive
stool straining)
_ _
•
intestinal obstruction, or colonic atony (weak
colon muscle).
_ _
_ _
_Pregnancy and lactation_
Consigel may be considered during pregnancy
and
lactation,
if
necessary
and
if
change
of
nutrition
is
not
successful.
Laxative
bulk
producers should be used before using other
purgatives.
_Before you start to use it _
•
The product should not be taken dry
and
should
always be
taken mixed
with fluid (8 fluid ounces or 240 mL
of water or other liquid per sachet).
Please
consume
a
large
amount
of
fluid/water when taking this product.
_ _
•
ConsiG

Summary of Product characteristics

WHAT IS CONSIGEL?
Description, Dosage form and Packaging
ConsiGel is a sugar-free high fibre drink containing natural soluble
fibre, 3.5g of ispaghula husk in a sachet.
This product comes in brown colour powder. After dissolved in water,
it is a yellow to brownish suspension with brown speckles.
The suspension is orange flavour. Available in a pack size of 10
sachets x 4.4g.
WHAT IS CONSIGEL USED FOR?
ConsiGel is recommended for the relief of constipation, including
constipation in pregnancy and the maintenance of bowel
regularity. This product also helps in the management of bowel
function in patients with:
- Colostomy
- Ileostomy
- Haemorrhoids (piles)
- Anal fissure
- Chronic diarrhoea associated with diverticular disease
- Irritable bowel syndrome
- Ulcerative colitis
HOW CONSIGEL WORKS?
ConsiGel contains ispaghula husk (or psyllium husk) which is a natural
fibre/ bulk laxative that helps to relieve constipation.
Pharmacodynamics
Ispaghula husk absorbs water in the gastrointestinal tract to form a
mucilaginous mass which increases the volume of faeces
and hence promotes peristalsis (muscle contractions) in the digestive
tract.
Pharmacokinetics
Ispaghula husk hydrates and swells to form a mucilage because it is
only partially solubilised. Polysaccharides, such as those
which dietary fibres are made of, must be hydrolysed to
monosaccharides before intestinal uptake can occur. The sugar
residues of the xylan backbone and the side chains are joined by
ß-linkages, which cannot be broken by human digestive
enzymes. Less than 10% of the mucilage gets hydrolysed in the stomach,
with formation of free arabinose. Intestinal absorption
of the free arabinose is approximately 85% to 93%. To varying degrees,
dietary fibre is fermented by bacteria in the colon,
resulting in production of carbon dioxide, hydrogen, methane, water,
and short-chain fatty acids, which are absorbed and
brought into the hepatic circulation. In humans, such fibre reaches
the large bowel in a highly polymerised form that is fermented
to a limited e