Picoprep Orange

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Citric acid 12.2 g; Magnesium carbonate monohydrate 7.4 g; Sodium picosulfate 10.3mg

Available from:

Fresenius Kabi New Zealand Limited

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Citric acid 12.2 g Magnesium carbonate monohydrate 7.4 g Sodium picosulfate 10.3mg Excipient: Orange flavour FACB076 Sweetener sweetesse 97

Prescription type:

Restricted

Therapeutic indications:

Picoprep Orange 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 examination), prior to intravenous pyelograms (IVP) or colorectal surgery.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 2 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 3 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 50 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2020-03-09

Patient Information leaflet

Page 1 of 5
PICOPREP ORANGE
®
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WARNING
LIFE
THREATENING
DEHYDRATION
AND/OR
ELECTROLYTE
DISTURBANCES
MAY OCCUR IN SOME PEOPLE. READ
THE
SECTION
WITH
THE
HEADING
“BEFORE YOU TAKE THIS MEDICINE”.
WHAT IS IN THIS LEAFLET?
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE
This leaflet answers some common
questions
about
PICOPREP
ORANGE. It does not contain all the
information
that
is
known
about
PICOPREP
ORANGE.
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
PICOPREP
ORANGE 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 IS
USED FOR
THIS MEDICINE BELONGS TO A
GROUP OF MEDICINES CALLED BOWEL
PREPARATIONS.
PICOPREP
ORANGE
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, in adults
and
children
9
years
of
age
and
over.
PICOPREP
ORANGE
contains
sodium
picosulfate,
citric
acid
and
magnesium
carbonate.
Citric
acid
reacts with magnesium carbonate to
form
magnesium
citrate.
Sodium
picosulfate
and
magnesium
citrate
both act as laxatives in the intestine.
Sodium picosulfate 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 o

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 7
WARNING
LIFE-THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR
IN “AT
RISK” GROUPS. SEE SECTION 4.3 CONTRAINDICATIONS AND 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE.
1 PRODUCT NAME
PICOPREP ORANGE
®
powder 20 g sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are:

sodium picosulfate has a chemical formula of C
18
H
13
NNa
2
O
8
S
2
,H
2
O, a MW of 499.4
and a CAS No. 10040-45-6 (anhydrous)

magnesium carbonate hydrate, has a chemical formula of MgCO
3
•H
2
O, a MW of
102.3 and a CAS No.23389-33-5;

citric acid which has a chemical formula of C
6
H
8
O
7
, a MW of 192.1 and a CAS No.
77-92-9.
Each PICOPREP ORANGE
®
sachet contains sodium picosulfate 10.3 mg, magnesium
carbonate hydrate 7.4 g and citric acid 12.2 g, as the active
ingredients.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for solution. For oral use.
PICOPREP ORANGE
®
contains 20 g of white to creamy yellow powder which when
dissolved in water produces 250 mL of solution with a mild citric acid
taste.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PICOPREP ORANGE
®
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 examination), prior to intravenous
pyelograms (IVP) or
colorectal surgery, in adults and children 9 years of age and over.
4.2
DOSE AND METHOD OF ADMINISTRATION
PRIOR TO THE PROCEDURE
During the day patients should drink at least one glass (approx. 250
mL) of Recommended
Clear Fluids (see APPENDIX I), in addition to the water taken with
PICOPREP ORANGE
®
,
each hour until bedtime to maintain hydration. It is recommended that
patients follow a
modified diet, such as a low-fibre diet, up until they take the
medication. Upon taking the
medication, the patient may only have Recommended Clear Fluids. It is
recommended that
patients cease taking any fluids two (