PACKAGE LEAFLET: INFORMATION FOR THE USER
Klean-Prep 69g Sachet, Powder for Oral Solution
Read all of this leaflet carefully before you start taking this medicine
- 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 symptoms are the same as yours.
- If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet:
- 1. What Klean-Prep is and what it is used for
- 2. Before you take Klean-Prep
- 3. How to take Klean-Prep
- 4. Possible side effects
- 5. How to store Klean-Prep
- 6. Further information
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1. What Klean-Prep is and what it is used for
When 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 have been given 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.
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2. Before you take Klean-Prep
Do not take Klean-prep if you have:
- an allergy to any of the ingredients
- a blockage of the bowel or perforation of the wall of the bowel
- ileus (loss of muscle tone in the gut)
- retention of food in the stomach
- an ulcer in your gut or stomach
- inflammation of the colon or an enlarged colon
Talk to your doctor before taking Klean-Prep if you:
- 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.
Taking other medicines
Do not take any other medicine by mouth within one hour of taking Klean-Prep. This is because another medicine will probably be flushed out before it has time to work.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including 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
Klean-Prep should only be used during pregnancy or whilst breast-feeding if considered essential by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Klean-Prep should not affect your ability to drive or use machines.
Important information about some of the ingredients of Klean-Prep
Klean-Prep contains aspartame, which is a source of phenylalanine, this may be harmful to people with phenylketonuria (a genetic disorder affecting metabolism).
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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. Start taking Klean-Prep the day before your hospital procedure.
If you have a morning appointment at the hospital, take Klean-Prep during the afternoon and evening of the day before you 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 rest the next morning. This takes about 2-3 hours each time.
To take Klean-prep:
- 1. Empty the contents of one sachet of Klean-Prep into 1 litre (one and three quarter pints) of water.
- 2. Stir until the solution is clear.
- 3. Drink 1 glassful (a quarter litre or half 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.
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 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
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4. Possible side effects
Like all medicines, Klean-Prep can cause side effects, although not everybody gets them.
- Feeling sick, a feeling of fullness in your stomach and bloating may all be experienced.
- Less frequently, you may experience abdominal cramps, vomiting or soreness of the anus (bottom). These effects usually pass off quickly.
- Rarely, people can be allergic to Klean-Prep, and may get an itchy skin rash (nettle rash or hives).
If a feeling of swelling of the stomach, or pain arises, you should drink Klean-Prep slower or stop until the pain or feeling goes away.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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5. How to store Klean-Prep
Keep all medicines out of the reach and sight of children.
Store Klean-Prep sachets in a dry place. Do not store above 25oC.
It is best to make up and use the 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 which is stated on the sachet/carton as month/year. The expiry date refers to the last day of the month.
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.
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6. Further information
What Klean-Prep contains
The active substances are Macrogol 3350, Sodium Sulphate, Sodium Bicarbonate, Sodium Chloride and Potassium Chloride. Each sachet contains:
| Macrogol 3350 |
59.0g |
| Sodium Sulphate |
5.685g |
| Sodium Bicarbonate |
1.685g |
| Sodium Chloride |
1.465g |
| Potassium Chloride |
0.743g |
The other ingredients are aspartame and vanilla flavour.
What Klean-Prep looks like and contents of the pack
Each sachet contains 69g Klean-Prep and 4 sachets come in one box.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is
Norgine Ltd
Moorhall Road
Harefield
Middlesex
UB9 6NS
UK
It is made for Norgine by
Helsinn-Birex Pharmaceuticals Ltd.
County Dublin
Ireland
UK Marketing Authorisation Number: PL 00322/0068
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The leaflet was last approved in: September 2008