Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Macrogol 3350, Potassium chloride, Sodium bicarbonate, Sodium chloride, Sodium sulfate, anhydrous may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
E KLEAN-PREP Do not take Klean-prep if you suspect or your doctor suspects: • 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)
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you have gastric retention you have toxic colitis and toxic megacolon you have congestive cardiac failure (Heart Failure)
Warnings and Precautions The fluid content of Klean-Prep when reconstituted with water does not replace regular fluid intake and adequate fluid intake should be maintained. 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 epilepsy or a history of convulsions have an inflammatory bowel disease such as ulcerative colitis (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 have heart failure, severe kidney problems or are taking blood pressure medicine
Some patients taking Klean-Prep have developed very low levels of sodium in the blood and as a result may experience convulsions, confusion or disorientation. If you experience sudden abdominal pain or rectal bleeding when taking Klean-Prep for bowel preparation, contact your doctor or seek medical advice immediately. If you experience (blood) vomiting followed by sudden chest, neck or abdominal pain, difficulty swallowing or difficulty breathing when taking Klean-Prep, stop taking medicine and promptly contact your doctor. Other medicines and Klean-prep Do not take other oral medicines during and at least one hour before and after taking Klean-Prep because they may be flushed through your digestive system and not work as well. If taking oral contraceptives, you may need to use additional forms of contraception (e.g. condom) to prevent pregnancy. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
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such as diuretics (that increase the amount of urine passed), laxatives (to help you pass stool or do a poo) and also medicines obtained without a prescription. If you use products to thicken fluids in order to swallow them safely, taking Klean-Prep may counteract this thickening effect. Klean-Prep with food and drink Do not take any solid food for at least two hours before you take Klean-Prep. Pregnancy, breast-feeding and fertility 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 125 mmol (2.9 g) sodium per sachet of treatment. 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. This medicine contains 49.4mg of Aspartame per sachet (68.96g). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
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.
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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 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 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 from 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.
• •
Oesophageal rupture due to vomiting
• • • • • • •
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 Convulsions (fits), confusion/disorientation linked with extremely low levels of sodium in the blood. Seizure Dehydration or feeling thirsty Headaches or dizziness Shivering or fever may occur. Malaise (general unwellness)
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•
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
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
KLEAN-PREP Keep this medicine out of the sight and reach of children. Store Klean-Prep sachets in a dry place. Do not store above 25°C. After you have dissolved Klean-Prep in the water, the solution may be stored in the fridge (2°C 8°C). Do not keep it for more than 24 hours. Do not use this medicine after the expiry date which is stated, after "EXP" on the carton. The expiry date refers to the last day of the 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.
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 Norgine Limited, New Road, Tir-Y-Berth, Hengoed, Wales, CF82 8SJ, UK
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Manufacturer Helsinn-Birex Pharmaceuticals Ltd., County Dublin, Ireland. The leaflet was last revised in April 2025. Other sources of information If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.
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KLEAN PREP 69g, sachet powder for oral solution comes as oral solution containing 69g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in KLEAN PREP 69g, sachet powder for oral solution is macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate, anhydrous.
This leaflet reproduces the patient information leaflet approved for KLEAN PREP 69g, sachet powder for oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For colonic lavage prior to diagnostic examination or surgical procedures requiring a clean colon, e.g. colonoscopy, barium enema or colonic resection.
Adults: Each sachet should be dissolved in 1 litre of water. The usual dose is up to 4 sachets taken at a rate of 250 ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician.
The solutions from all 4 sachets should be drunk within 4 to 6 hours. Alternatively, administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination.
If administration is by nasogastric tube, the usual rate should be 20 to 30 ml/minute.
Children: There is no recommended dosage.
Renal patients: No dosage adjustment need be made.
Do not use in patients with known or suspected:
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- gastrointestinal obstruction or perforation
- ileus
- gastric retention
- toxic colitis and toxic megacolon
- congestive cardiac failure (NYHA class III or IV)
The fluid content of Klean-Prep when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
No solid food should be eaten for at least 2 hours before taking Klean-Prep. The product should only be administered with caution to patients with impaired gag reflex, reflux oesophagitis, or those with diminished levels of consciousness and patients with ulcerative colitis.
There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance.
Unconscious, semi-conscious patients or patients prone to aspiration or regurgitation should be observed during administration especially if this is via the nasogastric route. There have been reports of pulmonary oedema resulting from aspiration of macrogol lavage solutions requiring immediate treatment.
Although not expected due to the isotonic composition of the product, cases of electrolyte disturbances have been rarely reported in at-risk patients. Therefore, Klean-Prep should be used with care in patients at risk of electrolyte disturbance, such as patients with renal failure, mild (NYHA class I and II) congestive cardiac impairment (see also section 4.3), or those simultaneously treated with diuretics.
Convulsions associated with severe hypnoatraemia in patients taking Klean-Prep have been reported (see section 4.8).
Patients may also develop confusional state/disorientation associated with hyponatraemia (see section 4.8).
Cases of seizures associated with use of macrogol 3350 with electrolytes for bowel preparation were observed in patients either with or without prior history of seizures. These cases were mostly associated with electrolyte abnormalities such as severe hyponatraemia (see section 4.8). Use caution when prescribing macrogol 3350 with electrolytes in patients with a history of seizures, at increased risk of seizure or at risk of electrolyte disturbance. In case of neurologic symptoms, fluid and electrolyte abnormalities should be corrected.
Should nausea, vomiting, abdominal distension or pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.
In debilitated patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate.
Caution should be used in patients with an impaired gag reflex, reflux oesophagitis, or diminished levels of consciousness.
Cases of oesophageal rupture (Boerhaave syndrome) associated with excessive vomiting after intake (see section 4.8) of macrogol 3350 with electrolytes for bowel preparation has been reported post-marketing, mostly in elderly patients. Advise patients to stop administration and seek immediate medical assistance if they experience incoercible vomiting and subsequent chest, neck, and abdominal pain, dysphagia, hematemesis or dyspnoea.
Klean-Prep contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.
Ischaemic colitis
Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.
Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
This medicinal product contains 125 mmol (2.9 g) sodium per sachet of treatment. To be taken into consideration by patients on a controlled sodium diet.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.
The interaction of Klean-Prep with other medicinal products has not been studied. Theoretically, oral medication (e.g. oral contraceptive pill) taken one hour before, during and one hour after the administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.
The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.
Klean-Prep may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
The preparation should only be used during pregnancy and lactation if considered essential by the physician. There is no experience of use during pregnancy. The purpose and mechanisms of use should be borne in mind if the physician is considering administration.
There is no known effect on the ability to drive and use machines.
The most commonly experienced undesirable effects are gastrointestinal in nature. The following Adverse Events have been observed in post-marketing experience and therefore the frequencies are not known:
System Organ Class
Adverse reaction
Immune system disorders
Allergic reactions including anaphylactic reaction, dyspnoea, skin reactions (see below)
Metabolism and nutrition disorders
Electrolyte disturbances, specifically Hypokalaemia, hyponatraemia and dehydration.
Nervous System Disorders
Seizures, convulsions (see section 4.4), confusional state/disorientation ( see section 4.4), headaches and dizziness
Cardiac disorders
Transient increase in blood pressure, arrhythmia, palpitations.
Gastrointestinal disorders
Oesophageal rupture (Boerhaave syndrome), vomiting, nausea, abdominal pain, anal discomfort, abdominal distension, flatulence.
Skin and subcutaneous tissue disorders
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
General disorders and administration site conditions
Rigors, malaise, pyrexia and thirst.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit juices, should be given.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Macrogol 3350, Potassium chloride, Sodium bicarbonate, Sodium chloride, Sodium sulfate, anhydrous. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Macrogol 3350, Potassium chloride, Sodium bicarbonate, Sodium chloride, Sodium sulfate, anhydrous. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about KLEAN PREP 69g, sachet powder for oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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