Velphoro Special Precautions

Peritonitis, gastrointestinal and hepatic disorders and gastrointestinal surgery: Patients with peritonitis, significant gastrointestinal or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro. Velphoro should only be used in these patients following careful assessment of benefit/risk.
Information about sucrose and starches (carbohydrates): Velphoro contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicinal product.
Velphoro contains potato starch and pregelatinised maize starch. Patients with diabetes should take notice that one tablet of Velphoro is equivalent to approximately 1.4g of carbohydrates (equivalent to 0.116 bread units).
Discoloured stool: Velphoro can cause discoloured (black) stool. Discoloured (black) stool may visually mask gastrointestinal (GI) bleeding (see Interactions).
Concomitant use of Velphoro with oral and intravenous iron products: In the Phase 3 study, concomitant intravenous but not oral iron use was allowed. Changes in iron parameters (e.g. increases in ferritin and TSAT, decreases in transferrin) which did not result in significant effects on haemoglobin and/or haematocrit values were observed in the Velphoro patients. Longer-term usage during the extension phase of the study did not show further significant changes in iron parameters. Velphoro should only be administered concomitantly with oral or intravenous iron supplementation after careful assessment of benefit/risk and periodic clinical monitoring of iron parameters should be performed.
Effects on Ability to Drive and Use Machines: Velphoro has no or negligible influence on the ability to drive and use machines.