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KLEAN-PREP POWDER FOR ORAL SOLUTION

Active substance(s): POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULPHATE

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Klean-Prep, Powder for Oral Solution

Ref: LTT122/041114/1/F

(sodium sulphate / sodium bicarbonate / sodium chloride /
potassium chloride / polyethylene glycol 3350)
Patient Information Leaflet
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
• 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. 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. This
includes any possible side effects not listed in this
leaflet. See Section 4.
You medicine is known as Klean-Prep, Powder for
Oral Solution however throughout this leaflet it will
be referred to as Klean-Prep.
In this leaflet:
1

What Klean-Prep is and what it is used for

2 What you need to know before you take
Klean-Prep
3 How to take Klean-Prep
4 Possible side effects
5

How to store Klean-Prep

6 Further information

1

What Klean-Prep is and what it is used
for

Klean-Prep is dissolved in water, it is a bowel
cleansing agent. This means it flushes everything
out of your intestines (gut) through a laxative action
so that they are completely empty and clean.
You are taking Klean-Prep because you are going to
have one of these procedures :
• Colonoscopy
• Barium enema
• Gut surgery
For all of these, it is important that your gut is clean
so the procedure is more likely to be a success.
2 What you need to know before you take

Klean-Prep
Do not take Klean-prep if you suspect or your
doctor supsects:
you are allergic (hypersensitive) to the active
• substances
or any of the other ingredients of
Klean-Prep (listed in section 6).
you have a blockage of the gastrointestinal
• obstruction
or perforation of the wall of the bowel
have ileus (loss of muscle tone in the gut)
• you
have gastric retention
• you
have toxic colitis and toxic megacolon
• you
you have congestive cardiac failure (Heart
• Failure)
Take special care with Klean-Prep
If you are in poor health or have a serious medical
condition, you should be particularly aware of the
possible side effects listed in section 4.
Contact your doctor or pharmacist if you are
concerned.
You should tell your doctor before taking Klean-Prep
if you have any of the following;
• have a problem swallowing
• have reflux oesophagitis (which is a condition
where acid from the stomach enters the
oesophagus (gullet))








have reduced levels of consciousness
have ulcerative colitis (which is an inflammatory
disease of the bowel which can cause abdominal
pain and bloody diarrhoea).
are prone to regurgitation (which is the return of
food from the stomach into the oesophagus
(gullet) and mouth) or aspiration (which is
breathing in of food and/or fluid into the airways).
These patients will need to be carefully monitored
during administration.
have heart problems including irregular
heartbeats or palpitations.
have kidney problems

Taking other medicines
If you are taking other medicines take them at least
one hour before taking KLEAN-PREP or at least one
hour afterwards because they may be flushed
through your digestive system and not work so well.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including diuretics (that increase the amount of urine
passed), and ACE (angiotensin-converting enzyme)
inhibitors (for treating high blood pressure and heart
failure) and also medicines obtained without a
prescription.
Taking Klean-Prep with food and drink
Do not take any solid food for at least two hours
before you take Klean-Prep.
Pregnancy and breast-feeding
There are no data on the use of Klean-Prep
during pregnancy or lactation and it should only be
used if considered essential by your physician .
So if you are pregnant or breastfeeding, think you
may be pregnant or are planning a baby,ask your
doctor or pharmacist for advice before taking
Klean-Prep.
Driving and using machines
Klean-Prep does not affect your ability to drive or
use machines.
Important information about some of the
ingredients of Klean-Prep
This medicinal product contains 125mM of
absorbable sodium per litre. To be taken into
consideration by patients on a controlled sodium
diet.
This medicinal product contains 10mM of potassium
per litre. To be taken into consideration by patients
with reduced kidney function or patients on
a controlled potassium diet.
Klean-Prep contains aspartame, which is a source
of phenylalanine, this may be harmful to people with
phenylketonuria (a genetic disorder affecting
metabolism).

3 How to take Klean-Prep
Always take Klean-Prep exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.



The usual dose is up to 4 sachets taken at a rate
of 250ml every 10 to 15 minutes until the total
volume is consumed or rectal effluent is clear, or
as directed by the physician. The solution from all
the 4 sachets should be drunk within 4 to 6 hours.

If you have a morning appointment at the
hospital:
• take Klean-Prep during the afternoon and
evening of the day before your appointment. This
will take about 4 to 6 hours altogether.

If you have an afternoon appointment:
• take 2 sachets on the evening before your
appointment, and the remaining 2 sachets the
next morning. This takes about 2-3 hours each
time.
How to take Klean-Prep

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information
on the safety of this medicine.

1. Empty the contents of one sachet
of Klean-Prep into 1 litre (1 3/4 pints)
of water.
5

How to store Klean-Prep

2. Stir until the solution is clear.
3. Drink 1 glassful (1/4 litre or 1/2 pint)
of Klean-Prep about every fifteen
minutes until you have drunk it all.
4. Make up and take the next sachets in the same
way. You should be starting to have watery bowel
movements so stay near a toilet. If after three
sachets you are passing only clear liquid, there is
no need to take the final sachet.
What else do I need to know?
You should start opening your bowels 1 to 2 hours
after starting to take Klean-Prep. If you have not had
a bowel movement after taking 2 sachets, wait until
you go to the toilet before you continue with
Klean-Prep. If you have slept the night and still not
have had any bowel movements, contact the
hospital for advice.
If you then take more Klean-Prep than you
should drink lots of liquids especially fruit juices.
If you forget to take Klean-Prep, take the next
dose as soon as you remember
Do not take a double dose to make up for a
forgotten dose
If you have any further questions on the use of this
product, ask your doctor or pharmacist.











Keep out of the sight and reach of children
Do not store above 25°C
Store in a dry place
Once reconstituted store in a refrigerator
Solution should be stored (keeping covered) in
the fridge (2°C to 8°C) if not consumed
immediately
After you have dissolvedKlean-Prep in water, It is
best to make up and use Klean-Prep solution as
you need it. If there is any left after 24 hours
throw it away
Do not use Klean-Prep after the expiry date
stated on the pack and sachets. The expiry date
refers to the last day of that month
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
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 infromation

What Klean-Prep contains
Each sachet contains 5.685g of sodium sulphate Ph.
Eur., 1.685g of sodium bicarbonate Ph. Eur., 1.465g
of sodium chloride Ph. Eur., 0.7425g of potassium
chloride Ph. Eur. and 59g of polyethylene glycol
3350. Also contains aspartame and vanilla flavour

4 Possible side effects
Like all medicines, Klean-Prep can have side
effects, although not everybody gets them.
The following side effects have sometimes been
seen but it is not known how often they occur
because the frequency cannot be estimated form
the available data:
• Feeling sick, a feeling of fullness in your stomach,
bloating and wind may all be experienced. You
may experience abdominal cramps, vomiting or
soreness of the anus (bottom). If you get a feeling
of nausea (feeling sick) swelling of the stomach, or
stomach pain, or you start to vomit, you should
drink Klean-Prep more slowly or stop drinking it for
a few minutes until you feel better.
• People can be allergic to Klean-Prep, and may get
an itchy skin rash (nettle rash or hives) or
reddening of the skin. They may also experience
swelling of the face, lips, tongue and throat, and
may also have difficulty in breathing and become
breathless. If you experience any of these
reactions you should contact a doctor immediately
for advice.
• A reduction in levels of sodium and potassium in
the blood. This is more common in people who are
taking medicines which affect the kidneys, such as
diuretics or ACE inhibitors.
• Convulsions (fits) linked with extremely low levels
of sodium in the blood.
• Headaches.
• Shivering may occur.
• Brief increase in blood pressure that may be linked
to bowel preparations. Irregular heartbeats or
palpitations.

What Klean-Prep looks like and contents of the
pack
Klean-Prep is a whitish powder which, when
dissolved in water, gives a clear, colourless solution
for oral administration.
Klean-Prep is available in pack of 1, 2, 3 and 4
sachets.
Manufacturer and Licence Holder
Klean-Prep is manufactured by Helsinn Birex
Pharmaceuticals Limited, Damastown, Mulhuddart,
Dublin 15, Ireland and is procured from within the
EU. Product Licence Holder: LTT Pharma Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
Klean-Prep is a registered trademark of Helsinn
Birex Pharmaceuticals Ltd.

P PL 33723/0122
Leaflet revision date: 04/11/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: LTT122/041114/1/B

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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.

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