Fortrans Special Precautions

This product should be administered to elderly patients in a frail general condition only under medical supervision. Diarrhoea provoked by administration of FORTRANS is likely to result in considerable disturbance of the absorption of simultaneously administered drugs. This medicine contains macrogol (polyethylene glycol or PEG). Allergic type reactions have been reported with preparations based upon macrogol: anaphylactic shock, rash, urticarial, angio-oedema.
Electrolytes disturbances are not expected with this product due to its isotonic composition; however, water electrolytes disturbances have been exceptionally reported in at risk patients. Patients with electrolyte abnormalities should have them corrected before administration of the bowel cleansing preparation. This product should be used with caution in patients with these conditions or in patients using concomitant medications that increase the risk of fluid and electrolytes disturbances including hyponatremia and hypokalemia, or may increase the risk of potential complications (such as patients with renal function altered, cardiac insufficiency or treated concomitantly with diuretics). In this case, patients should be appropriately monitored.
The product should be administered carefully and only under medical supervision in patients with tendency to regurgitations or bedridden patients or patients with altered neurological function and/or motor disorders due to the risk of aspiration pneumonia. The product should be administered to these patients in sitting position and eventually through a naso-gastric probe. In patients with cardiac or renal insufficiency, there is a risk of acute pulmonary oedema due to water overload.
This medicine contains sodium. This medicine contains 2.890 g of sodium per sachet. To be taken into account in patients with strict low-salt diet.
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 with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.