Glycoprep-O Kit

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bisacodyl 5mg; Citric acid 14.3 g; Magnesium carbonate monohydrate 7.2 g; Macrogol 3350 52.9 g;  ; Potassium chloride 740mg; Sodium chloride 2.6 g; Sodium sulfate 5.6 g

Available from:

Fresenius Kabi New Zealand Limited

Pharmaceutical form:

Combination

Composition:

Active: Bisacodyl 5mg Excipient: Calcium carbonate Colloidal silicon dioxide Gelatin Lactose monohydrate Macrogol 6000 Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Povidone   Purified talc   Quinoline yellow Silicon Sodium starch glycolate Starch Sucrose Active: Citric acid 14.3 g Magnesium carbonate monohydrate 7.2 g Macrogol 3350 52.9 g   Potassium chloride 740mg Sodium chloride 2.6 g Sodium sulfate 5.6 g Excipient: Ascorbic acid Colloidal silicon dioxide Orange flavour FACB076 Sweetener sweetesse 97

Prescription type:

Restricted

Therapeutic indications:

Glycoprep-O Kit is indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination (such as colonoscopy, barium enema x-ray examinations), prior to intravenous pyelograms (IVP) or colorectal surgery.

Product summary:

Package - Contents - Shelf Life: Blister pack, Bisacodyl tablet: aluminium foil blister strip - 3 tablets - 24 months from date of manufacture stored at or below 25°C - Combination pack, Glycoprep Orange sachet X3 Magnesium citrate X 1 Bisacodyl tablets X3 - 7 dose units - 24 months from date of manufacture stored at or below 25°C protect from moisture - Sachet, laminate, Magnesium Citrate sachet: aluminium laminated with LDPE/paper - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from moisture - Sachet, laminate, Glycoprep Orange sachet: aluminium laminated with LDPE/paper - 3 dose units - 24 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2020-12-11

Patient Information leaflet

Page 1 of 5
GLYCOPREP-O KIT™
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE
This leaflet answers some of the
common
questions
people
ask
about GLYCOPREP-O KIT. It does
not
contain
all
the
available
information. It does not take the
place
of
talking
to
your
doctor,
prescriber or pharmacist.
Ask
your
doctor,
prescriber
or
pharmacist:

if there is anything you do not
understand in this leaflet,

if you are worried about taking
your medicine, or

to obtain the most up-to-date
information.
All
medicines
have
risks
and
benefits. Your doctor, prescriber or
pharmacist will have weighed the
risks of you taking GLYCOPREP-
O
KIT
against
the
benefits
they
expect it will have for you.
Pharmaceutical companies cannot
give
you
medical
advice
or
an
individual diagnosis.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE KIT
IS USED FOR
THIS MEDICINE KIT BELONGS TO A
GROUP
OF
MEDICINES
CALLED
BOWEL PREPARATIONS.
GLYCOPREP-O
KIT
is
used
to
remove
the
bowel
contents
and
cleanse it prior to gastrointestinal
examination (such as colonoscopy,
barium enema x-ray examination),
prior
to
intravenous
pyelograms
(IVP) or colorectal surgery.
GLYCOPREP-O KIT components
are
GLYCOPREP
ORANGE
sachet, magnesium citrate sachet
and bisacodyl tablets.
GLYCOPREP
ORANGE
contains
macrogol, which acts as a laxative
in the intestine. Macrogol works by
causing excess water to remain in
your
stool
and
stimulates
bowel
movements.
Magnesium citrate also works by
causing excess water to remain in
your
stool
and
stimulates
bowel
movements.
Bisacodyl works by being broken
down
by
intestinal
bacteria
and
then acting on the lining in your
intestine
to
stimulate
bowel
movements.
This
results
in
watery
stool
or
bowel motions which removes the
bowel
contents
and
ensures
the
bowel
is
clean
before
the
examination
or
procedure.
The
bowel
needs
to
be
clean
before
the
examination
or
procedure.
GLYCOPREP-O
KIT
produces
watery
stools
or
bowel
motions
wi

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 8
1 PRODUCT NAME
GLYCOPREP-O KIT (Combination pack)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GLYCOPREP-O KIT is a medicine kit containing:

Three (3) yellow Bisacodyl BP 5 mg Tablets. Each bisacodyl tablet
contains
bisacodyl 5 mg, as the active ingredient.

One (1) MAGNESIUM CITRATE 21.5 g sachet. Each sachet contains
magnesium
carbonate hydrate 7.2 g and citric acid 14.3 g, as the active
ingredients.

Three (3) 70 g sachets of GLYCOPREP ORANGE
®
. Each 70 g sachet contains
macrogol 3350 (polyethylene glycol) 52.9 g, potassium chloride 740 mg,
sodium
chloride 2.6 g and sodium sulfate 5.6 g, as active ingredients. Total
sodium content
in 70 g sachet is 2.86 g.
Chemical structure
_Macrogol 3350 _
H(OCH
2
CH
2
]nOH (where ‘n’ equals 45 to 70).
Molecular weight: varies
_Potassium chloride _
KCl
Molecular weight: 74.6 g/mol
_Sodium chloride _
NaCl
Molecular weight: 58.44 g/mol
_Sodium sulfate _
Na
2
SO
4
Molecular weight: 142.0 g/mol
_Magnesium carbonate hydrate _
MgCO
3
Molecular weight: 84.31 g/mol
_Citric acid _
C
6
H
8
O
7
Molecular weight: 192.1 g/mol
_Bisacodyl _
C
22
H
19
NO
4
Molecular weight: 361.4 g/mol
Page 2 of 8
CAS number
ACTIVE SUBSTANCE
CAS NUMBER
Macrogol 3350
9002-90-8
Potassium chloride
7447-40-7
Sodium chloride
7647-14-5
Sodium sulfate
7757-82-6
Bisacodyl
603-50-9
Magnesium carbonate hydrate
546-93-0
Citric acid
77-92-9
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
GLYCOPREP ORANGE
®
sachet: Powder for solution. For oral use.
GLYCOPREP ORANGE
®
contains a white to creamy yellow powder which when dissolved
in water produces 1 litre of cloudy solution with a mild citric taste.
MAGNESIUM CITRATE sachet: Powder for solution. For oral use.
Magnesium citrate is a white crystalline powder which when dissolved
in water produces
250 mL of cloudy solution with a mild citric taste.
Bisacodyl BP 5 mg Tablets: Enteric-coated tablets. For oral use.
Bisacodyl is a round yellow enteric-coated tablet.
4 CLINICAL PARTICUL