VISTAPREP

Posology For complete bowel cleansing, 3 up to a maximum of 4 litres of VistaPrep solution must be taken. 1 sachet corresponds to 1 L solution. Paediatric population VistaPrep should not be used in children because the safety has not been established in this patient group.

Method of administration The route of administration is for oral use. The solution is drunk in portions of 200 - 300 mL every 10 minutes until the rectal effluent is clear or 4 litres maximum have been drunk. Administration takes place over a period of about 4 hours, generally on the examination day.

The total amount required can also be taken on the evening before, or a part taken on the evening before and the remaining amount on the morning of the examination day. Patients should consume no solid food for 2 to 3 hours prior to administration of VistaPrep until after the examination.

6. 2 Incompatibilities.

System organ class MedDRA frequency convention Common (>1/100 to <1/10) Very common (≥ 1/10) Gastrointestinal disorders Vomiting, stomach cramps, anal irritation Nausea, feeling of fullness, flatulence These phenomena are largely attributable to the drinking of relatively large amounts of liquid within a short period of time.

Upon occurrence of gastrointestinal symptoms, administration of VistaPrep should be temporarily slowed down or discontinued until the symptoms subside. System organ class MedDRA frequency convention Uncommon (>1/1,000 to <1/100) Very rare (<1/10,000) General disorders and administration site conditions General malaise, insomnia Cardiac disorders Cardiac arrhythmias, tachycardia, pulmonary oedema Investigations Clinically relevant decrease in the serum levels of calcium, potassium and sodium Nervous system disorders Neurological effects ranging from mild disorientation up to generalised seizures as a consequence of altered serum levels of electrolytes (see “Investigations”) Immune system disorders Urticaria, rhinorrhoea, dermatitis, probably of allergic origin; anaphylactic shock Note: In the literature, cases have been documented where Mallory-Weiss syndrome occurred as a result of vomiting after administration of bowel lavage solutions containing macrogol.

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.

VistaPrep should be administered only under medical supervision in elderly patients and those with reflux oesophagitis or pre-existing cardiac arrhythmias, known or suspected SA block or sick sinus syndrome. Use is possible in patients with chronic inflammatory bowel disease (exception: highly florid stages and toxic megacolon).

However, VistaPrep must be administered with caution in these patients, preferably under medical supervision. In patients with heart failure (NYHA class III and IV), renal insufficiency, liver disease or in patients with severe dehydration, VistaPrep should not be used, as the safety of use has not been sufficiently documented in these groups.

g. elderly or debilitated patients, careful monitoring of the electrolyte and fluid balance is required. 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.

This medicine contains 20 mmol potassium and 260 mmol sodium per 4 litres of VistaPrep solution. This should be taken into consideration by patients on a controlled potassium or sodium diet and for patients with reduced kidney function.

Ileus and suspected ileus, gastrointestinal obstruction or perforation, risk of gastrointestinal perforation, hyperflorid colitis, toxic megacolon, gastric emptying disorders. 1. VistaPrep should not be administered to unconscious patients or those with impaired consciousness and patients prone to aspiration or regurgitation, general weakness or impaired swallowing reflex.