Klean-Prep® Powder for Oral Solution

(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:

Q What Klean-Prep is and what it is used for Q What you need to know before you take Klean-Prep

^ How to take Klean-Prep Q Possible side effects Q How to store Klean-Prep Q Further information

A What Klean-Prep is and what it is used ^w 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.

Q 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

•    you have ileus (loss of muscle tone in the gut)

•    you have gastric retention

•    you have toxic colitis and toxic megacolon

•    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).

Q 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

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

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.

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.

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.

How to store Klean-Prep

•    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.

^ 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

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.

[g PL 33723/0122

Leaflet revision date: 04/11/14

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Ref: LTT122/041114/1 /B