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Package leaflet: Information for the patient


Powder for oral solution
Sodium Picosulfate / Magnesium Oxide / Citric Acid

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
• Keep this leaflet. You may need to
read it again
• If you have any further questions,
ask your doctor or pharmacist
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4

What is in this leaflet
1. What Picolax® is and what it is used for
2. What you need to know before you
take Picolax®
3. How to take Picolax®
4. Possible side effects
5. How to store Picolax®
6. Contents of the pack and other

1. What Picolax® is and what it
is used for
Picolax® is a powder that contains
sodium picosulfate, a laxative that works
by increasing the activity of the intestine.
Picolax® also contains magnesium
citrate, another type of laxative that
works by holding back fluid in the bowel
to provide a wash-out effect.
Picolax® is used in adults, adolescents
and children from the age of 1 year
to clear the bowel before an x-ray
examination, endoscopy or surgery when
judged clinical necessary.

2. What you need to know
before you take Picolax®
Do not take Picolax® if you:
• are allergic to sodium picosulfate /
magnesium oxide / citric acid or any of
the other ingredients of this medicine
(listed in section 6)
• have reduced ability of the stomach to
empty (gastric retention)
• have stomach or intestinal ulcers
• have severe problems with your
• have a blockage or perforation of your
• are currently suffering from feeling or
being sick
• have a condition requiring abdominal
surgery such as acute appendicitis
• have been told by a doctor that you
have congestive heart failure (the heart
is unable to pump blood efficiently
around the body)
• have active inflammatory bowel
disease such as Crohn’s disease or
ulcerative colitis
• have been told by your doctor that
you have too much magnesium in your
• are very thirsty or may be severely
• have been told by your doctor that
you have damaged muscles that are
leaking their contents to your blood
• have a condition called:
- ileus (intestinal blockage or failure of
normal bowel movements),
- toxic colitis (damage to the intestinal
- toxic megacolon (expansion of the
large bowel)
In these conditions, the movement of the
contents of the bowel may be impaired
or prevented. Symptoms include nausea,
vomiting, diarrhoea, abdominal pain,
tenderness or swelling, colicky pain and
Warnings and precautions
Talk to your doctor or pharmacist before
taking Picolax®:
• if you have recently had abdominal
• if you have a heart disease or kidney
• if you have inflammatory bowel disease
such as ulcerative colitis or Crohn’s

• if you are younger than 18 years,
elderly or physically weak. You should
make sure to drink a sufficient amount
of fluid and electrolytes during the
course of the treatment
• if you are taking Picolax® prior to
surgery involving the bowel
If you have an early time of the day
procedure, you might need to take the
second dose during night and possible
sleep disturbance may occur.
Other medicines and Picolax®
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
It is especially important to tell your
doctor if you are taking:
• bulk forming laxatives e.g. bran
• prescribed oral medication, especially
if it is regularly prescribed as
their effects may be modified e.g.
contraceptives, antibiotics, antidiabetics, iron, penicillamine or antiepileptics. These medicines should be
taken at least 2 hours before and not
less than 6 hours after administration
of Picolax®
• prescribed medication that may affect
water and/or electrolyte balance e.g.
water tablets, steroids, lithium, digoxin,
antidepressants, carbamazepine or
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are trying
to have a baby, ask your doctor or
pharmacist for advice before taking this
Driving and using machines
Picolax® has no effect on the ability to
drive and use machines. However, you
should make sure that you have access
to a toilet at all times following each
dose, until the effect wears off.
Picolax® contains potassium and
Each sachet contains 5 mmol (or 195 mg)
potassium. You should discuss this with
your doctor if you have kidney problems
or you have been put on a controlled
potassium diet.
This medicine also contains lactose. If
you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Picolax®
Always take Picolax® exactly as your
doctor has told you. Check with your
doctor if you are not sure.
Picolax® powder should be dissolved in a
cup of cold water (approximately 150ml).
Stir for 2-3 minutes and then drink
the solution. Sometimes the solution
becomes hot as Picolax® dissolves. If this
happens, wait until it cools sufficiently
before drinking it.
Adults (including elderly) and children
9 and over
The recommended dose is one sachet
taken 10 to 18 hours before your
procedure and one sachet taken 4 to
6 hours before your procedure. The
first sachet taken, should be followed
by at least five 250 ml drinks of clear
liquids spread over several hours and
the second sachet taken, should be
followed by at least three 250 ml drinks
of clear liquids spread over several hours.
You may drink clear liquids until 2 hours
before your procedure.
Children (under 9 years)
For the timing of dosing in children, refer
to the instructions given for adults
A measuring spoon is provided with the
From 1 and below 2 years: first dose is 1
spoonful, second dose is 1 spoonful
From 2 and below 4 years: first dose is 2
spoonfuls, second dose is 2 spoonfuls
From 4 and below 9 years: first dose
is 1 sachet (taken as described under
‘adults’), second dose is 2 spoonfuls
9 years and above: adult dose.

To measure the dose with the measuring
• Fill the spoon with a heap of powder
from the sachet
• Pass the flat back of a knife across the
top of the measuring spoon
• The powder left in the measuring
spoon is one spoonful (4g of powder)
• Pour the powder from the spoon into a
cup of water. The cup should contain:
- Approximately 50 ml of water if you
are measuring one spoonful of
- Approximately 100 ml of water
If you are measuring two spoonfuls of
• Stir in the cup for 2-3 minutes
• Drink the solution. Sometimes the
solution becomes warm as Picolax®
dissolves. If this happens, wait until it
cools sufficiently before drinking it
• Discard any remaining powder from
the sachet
You should expect frequent, loose bowel
motions to start at any time after taking
a dose of Picolax®. Please ensure that
you have access to a toilet at all times
following each dose, until the effects
wear off.
In order to replace fluid lost from the
body, it is important to drink plenty of
clear liquids throughout the treatment
with Picolax® until the bowel movements
have ceased. In general, you should try
to drink clear liquids when you are thirsty.
Clear liquids should include a variety
of fruit juice without pulp, soft drinks,
clear soup, tea, coffee (without milk, soy
or cream) and water. Do not drink only
The success of your hospital procedure
that you undergo depends on the bowel
being as clear as possible. The procedure
may need to be repeated if you do not
achieve a clear bowel. You should always
follow the dietary instructions given by
your doctor.
If you take more Picolax® than you
If you have taken more Picolax® than you
should, contact your doctor immediately
or go to the casualty department at your
nearest hospital.
If you forget to take Picolax®
Please consult your doctor, nurse or
pharmacist for advice.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
There have been isolated reports of
severe prolonged abdominal pain in
some patients which may indicate a
serious condition and require urgent
medical care, and isolated reports of
severe allergic reactions which may lead
to difficulty in breathing.
Isolated cases of mild ulcers in the small
bowel have also been reported.
In the case of allergic reaction or
severe prolonged abdominal pain,
contact your doctor or nearest
casualty department immediately.
The known side effects of Picolax® are
described below:
Common (affects less than 1 in 10 but
more than 1 in 100 patients):
• Headache
• Nausea
• Proctalgia (anal pain)
Uncommon (affects less than 1 in 100
but more than 1 in 1,000 patients):
• Rash and/or itching
• Vomiting and severe diarrhoea can
lead to dehydration with headache
and confusion without proper fluid and
salt replacement
• Abdominal pain
• Vomiting
• Low levels of sodium or potassium
in the blood (hyponatraemia or
hypokalaemia) with or without
associated fits. Fits have occasionally
been reported in epileptic patients
Other side effects for which the
occurrence is not known:
• As the primary clinical effect, very
regular, loose bowel movements, or
diarrhoea may happen. However, if
your bowel movements become
troublesome or give you concern, you
should contact your doctor

If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any side
effects not listed in this leaflet. You can
also report side effects directly via the
Yellow Card Scheme,
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Picolax®
Keep this medicine out of sight and reach
of children.
Store in the original packaging in order to
protect from moisture.
Single use only. Discard any unused
Do not use this medicine after the expiry
date which is stated on the carton and
sachet. The expiry date refers to the last
day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and
other information
What Picolax® contains
The active substances of 1 sachet are
10 mg sodium picosulfate, 3.5 g
magnesium oxide light and 12 g
anhydrous citric acid
The other ingredients are potassium
hydrogen carbonate, saccharin sodium
and natural, spray-dried orange flavour
which includes acacia gum, lactose,
ascorbic acid, butylated hydroxyanisole.
What Picolax® looks like and contents
of the pack
Your medicine is called Picolax®. It is a
powder for oral solution. It is supplied
in packs of 2 sachets, 100 sachets (50
packs, each containing 2 sachets), or 300
sachets (150 packs, each containing 2
A measuring spoon is included in the
pack, in order to ensure correct dosing
for children. The spoon is used to
measure 4 g of powder (4.75 ml). You
should only use the spoon if you are
dosing a child under 9 years.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ferring Pharmaceuticals Limited,
Drayton Hall, Church Road,
West Drayton, UB7 7PS, UK.
Ferring GmbH, Wittland 11,
D-24109 Kiel, Germany
This medicinal product is authorised in
the Member States of EEA under the
following names
United Kingdom
Austria, Belgium, Bulgaria, Cyprus,
Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece,
Hungary, Iceland, Italy, Latvia, Lithuania,
Luxembourg, Netherlands. Norway,
Portugal, Romania, Slovak Republic,
Spain, Sweden
This leaflet was last revised in
August 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.