Bowel cleansing preparation for colonoscopy in adults
PIP code: 4048872 References
1. VistaPrep® (macrogol 3350), Summary of Product Characteristics, Tillotts Pharma UK Ltd., March 2018.
2. MIMS Online. Available at: https://www.mims.
co.uk. Accessed May 2018.
3. American Society for Gastrointestinal Endoscopy. Standards of Practice Committee. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j. gie.2014.09.048. Epub 2015 Jan 14.
VistaPrep (macrogol 3350) powder for oral solution - Prescribing Information
Please consult the Summary of Product Characteristics (SmPC) for full prescribing Information
Presentation: sachets containing powder for oral
solution. Each sachet contains 105g Macrogol 3350, 2.80g sodium chloride, 1.43g sodium bicarbonate and 0.37g potassium chloride. Each sachet should be dissolved in 1 litre of water. For oral use. Indications: for bowel cleansing in preparation for colonoscopy in adults over 18 years. Dosage and administration: for complete bowel cleansing, 3 up to a maximum of 4 litres of VistaPrep solution must be taken. Drink in portions of 200 - 300 mL every 10 minutes until the rectal effluent is clear or 4 litres maximum have been drunk. Administer over a period of about 4 hours, generally on examination day. The total amount can also be taken on the evening before, or part on the evening before and the remainder on the morning of the examination day. Patients should consume no solid food for 2 to 3 hours prior to administration and until after the examination. Paediatric population: VistaPrep should not be used in children. Contraindications: Ileus/suspected ileus, gastrointestinal obstruction or perforation, risk of gastrointestinal perforation, hyperflorid colitis, toxic megacolon, gastric emptying disorders. Hypersensitivity to the active substances, other macrogols, saccharin sodium, orange flavour, lemon-lime flavour, colloidal anhydrous silica, or any of the excipients. Do not administer to unconscious patients or those with impaired consciousness and patients prone to aspiration or regurgitation, general weakness or impaired swallowing reflex. Warnings and Precautions: administer 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 with caution and preferably under supervision in patients with chronic inflammatory bowel disease (exception: highly florid stages and toxic megacolon). Do not use in patients with heart failure (NYHA class III and IV), renal insufficiency, liver disease or in patients with severe dehydration. In certain patients at risk, e.g. elderly or debilitated patients, careful monitoring of the electrolyte and fluid balance is required. Contains 20 mmol potassium and 260 mmol sodium per 4 litres of VistaPrep solution. Care in patients on a controlled potassium or sodium diet and patients with reduced kidney function. Interactions: up to several hours before, during or up to one hour after VistaPrep, orally administered medicines may be washed out of the GI tract or absorption may be affected,
especially delayed-release medicines. If
administration of a medicine is absolutely necessary for a life-threatening indication shortly before or whilst taking VistaPrep, oral administration may have to be withheld and a switch made to an alternative. In diagnostic tests of the discharged intestinal liquid using enzymatic assay procedures (e.g. ELISA), there may be interactions between macrogol 3350 and the enzymatic assays. Fertility, pregnancy and lactation: may be administered to pregnant women after careful risk-benefit assessment. Can be taken by breast-feeding women if deemed necessary. No data on the effects of VistaPrep on fertility in humans. Adverse reactions: Very common: nausea, feeling of fullness, flatulence. Common: vomiting, stomach cramps, anal irritation. Uncommon: general malaise, insomnia. Very rare: cardiac arrhythmias, tachycardia, pulmonary oedema, clinically relevant decrease in the serum levels of calcium, potassium and sodium, neurological effects ranging from mild disorientation up to generalised seizures as a consequence of altered serum levels of electrolytes, urticaria, rhinorrhoea, dermatitis, probably of allergic origin; anaphylactic shock. Prescribers should consult the summary of product characteristics in relation to other adverse reactions. Marketing Authorisation Numbers, Package Quantities and basic NHS price: PL 36633/0008. Packs of 4 sachets: £7.92. Legal category: P. Marketing Authorisation Holder: Tillotts Pharma UK Ltd, Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX. Date of preparation of PI: April 2018
Adverse events should be reported. Reporting forms and information can be found at https://
yellowcard.mhra.gov.uk. Adverse events should also be reported to Tillotts Pharma UK Ltd. Tel: 01522 813500.
Date of preparation: May 2018 PU-00167 Powder for oral solution
Macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride1
Powder for oral solution Powder for oral solution
The lowest cost macrogol indicated for oral bowel cleansing available in the UK*2
Sulphate-free to aid palatability3 *Aiding budget efficiency2
For a clear view
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