KLEAN-PREP

Adults:

Each sachet should be dissolved in 1 litre of water. 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 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 30ml/minute.

Children:

There is no recommended dosage.

Renal patients:

No dosage adjustment need be made.

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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

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. 3), or those simultaneously treated with diuretics. 8). 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.

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.

1 - gastrointestinal obstruction or perforation - ileus - gastric retention - toxic colitis and toxic megacolon - congestive cardiac failure (NYHA class III or IV)