Vistaprep Powder for oral solution
- Name:
Vistaprep Powder for oral solution
- Company:
Mareike Würz
- Active Ingredients:
Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/20

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Mareike Würz

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Medicine Name Vistaprep Powder for oral solution | Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 30 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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.
Updated on 30 November 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
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.
Updated on 8 October 2018 SPC
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 29th January 2016
Date of last renewal: 11th September 2017
10. DATE OF REVISION OF THE TEXT
May 2016October 2018
Updated on 15 September 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 15 September 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)