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Powder for oral solution

Read all of this leaflet carefully before
you start using this medicine.
• Keep this leaflet, you may need to read
it again.
• If you have further questions, please
ask your doctor or pharmacist.
• This medicine has been prescribed for
you personally and you should not pass
it on to others. It may harm them even if
their symptoms are the same as yours.
• 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 pharmacist.

In this leaflet:
1. What PICOLAX is and what it is used for
2. Before you take PICOLAX
3. How to take PICOLAX
4. Possible side effects
5. How to store PICOLAX
6. Further information

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 to clear your bowel before
you have an x-ray examination, endoscopy
or surgery.

2. Before you take Picolax®
Do not take Picolax® if you:
• are allergic (hypersensitive) to sodium
picosulfate or any of the other ingredients
• have reduced ability of the stomach to
empty (gastric retention)
• have stomach or intestinal ulcers
• have severe problems with your kidneys
• have a blockage or perforation of your
• are currently suffering from feeling or
being sick
• have a condition requiring abdominal
surgery such as 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
• have been told by your doctor that you
have too much magnesium in your blood
• are very thirsty or may be severely
• have been told by your doctor that you
have damage muscles that are leaking
their contents to your blood
• have a condition called:
• ileus (intestinal blockage or failure of
normal bowel movement)
• toxic colitis (damage to the intestinal
• toxic megacolon (expansion of the large
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

Take special care with
if you:
• have recently had abdominal surgery
• have a heart disease or kidney problems
• have inflammatory bowel disease such as
ulcerative colitis or Crohn’s disease
• are younger than 18 years, elderly or
physically weak. You should make sure to
drink sufficient amount of fluid and
electrolytes during the course of the
• are taking Picolax® prior surgery involving
the bowel
If any of these apply to you, or if you are
not sure, contact your doctor before taking

Taking other medicines:
Please inform your doctor or pharmacist if
you are taking or have recently taken any
other medicines - including medicines
obtained without a prescription.
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, anti-diabetics, iron,
penicillamine, or anti-epileptics. 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 antipsychotics
Pregnancy and breast-feeding:
If you are pregnant, trying to become
pregnant, or are breast-feeding, ask your
doctor or pharmacist for advice before
taking Picolax®.
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.
Important information about some of the
ingredients of Picolax®:
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. You should check with your
doctor if you are not sure.
Picolax® powder should be dissolved in a
cup of cold water (approximately 150 ml).
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
Adults (including the elderly) and
children 9 and over:
The usual dose is one sachet in the
morning and one sachet in the afternoon on
the day before your procedure.
The first sachet taken before 8am, and the
second sachet 6 to 8 hours later.
Children (under 9 years): Timings as above
A measuring spoon is provided with the product.
From 1 and below 2 years: 1 spoonful
morning, 1 spoonful afternoon
From 2 and below 4 years: 2 spoonsfuls
morning, 2 spoonfuls afternoon
From 4 and below 9 years: 1 sachet morning
(taken as described under ‘adults’), 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 conain:
• 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

continued overleaf

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 fluids
throughout the treatment with Picolax® until
the bowel movement have ceased. In
general, you should try to drink a glass of
water (about 250 ml) or other clear fluid
every hour whilst the effects of Picolax®
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.

5. How to store Picolax®
Keep out of reach and sight of children.
Store in the original packaging in order to
protect from moisture.
Single use only. Discard any unused
Do not use Picolax® after the expiry date
which is stated on the sachet.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6. Further information

If you take more Picolax® than you should:
If you have taken more Picolax® than you
should, contact your doctor immediately or
go to the casualty department at your
nearest hospital.

What Picolax® contains:
The active substances are 10 mg sodium
picosulfate, 3.5 g magnesium oxide light
and 12 g anhydrous citric acid.

If you forget to take Picolax®:
Please consult your doctor, nurse or
pharmacist for advice.

The other ingredients are potassium
hydrogen carbonate, saccharin sodium and
natural spray-dried orange flavour which
includes acacia gum, lactose, ascorbic
acid, butylated hydroxyanisole.

4. Possible side effects
Like all medicines, Picolax® can cause side
effects, althought not everybody gets them.
There have been isolated reports of severe
prolonged abdominal pain in some patients
which may indicate a serious condition and
required 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
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
• 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
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
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or

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 sachets).
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 Ltd.
Drayton Hall, Church Road, West Drayton,
UB7 7PS, (UK).
Picolax®: PL 03194/0014
Pharmaserve Ltd.
Clifton Technology Park,
Wynne Avene, Swinton,
Manchester M27 8FF (UK).
Ferring GmbH
Wittland 11, D-24109 Kiel,
This leaflet was last DSSURYHG in 'HFember 201.

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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.