Vistaprep Powder for oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/20

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Summary of Product Characteristics last updated on medicines.ie: 30/11/2020

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Tillotts Pharma GmbH

Tillotts Pharma GmbH

Company Products

Medicine NameActive Ingredients
Medicine Name Asacolon 1600 mg modified-release tablets Active Ingredients Mesalazine
Medicine Name Asacolon 400 mg Gastro-Resistant Tablet Active Ingredients Mesalazine
Medicine Name Asacolon 500 mg Suppositories Active Ingredients Mesalazine
Medicine Name Asacolon 800 mg Gastro-Resistant Tablets Active Ingredients Mesalazine
Medicine Name DIFICLIR 200 mg film-coated tablets Active Ingredients Fidaxomicin
Medicine Name Entocort CR 3mg Capsules Active Ingredients Budesonide
Medicine Name Vistaprep Powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
1 - 0 of 7 items.Total: Infinity pages

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)