KLEAN-PREP Powder for oral solution Ref.[28210] Active ingredients: Macrogol Potassium chloride Sodium bicarbonate Sodium chloride Sodium sulfate

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).

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.

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.

Oral medication taken within one hour of administration of Klean-Prep may be flushed from the gastro-intestinal tract and not absorbed.

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:

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 store.

None are known.