4.4    Special warnings and precautions for use

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.

In certain patients at risk, e.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.

Warnings and precautions

Contact your doctor:

• if you are an elderly patient
• if you have reflux disease (“heartburn”, reflux oesophagitis)
• if you have existing problems with your heart rhythm (SA block or sick sinus syndrome)
• if your heart does not pump efficiently (a condition called “heart failure”), and you have discomfort when performing light to moderate exercise or while resting
• if your kidneys and/or liver are not working efficiently (renal and hepatic insufficiency)
• if you have kidney failure or liver disease
• if you have severe dehydration
• if you have severe colitis, diverticulitis or chronic inflammatory bowel disease

In these cases Vistaprep can only be used under the supervision of a doctor who will check your electrolytes and fluid balance.

If you experience sudden abdominal pain or rectal bleeding when taking Vistaprep for bowel preparation, contact your doctor or seek medical advice immediately.

9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of First Authorisation: 29^th January 2016

Date of last renewal: 11^th September 2017

 10.    DATE OF REVISION OF THE TEXT

 May 2016October 2018