Treatment of high blood phosphorus levels usually requires long-term treatment.
4.3 Contraindications
 • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Bowel obstruction.

Go to top of the page4.4 Special warnings and precautions for use
 The safety and efficacy of BindRen has not been studied in patients with:

• Dysphagia or swallowing disorders

• Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery

• Biliary obstruction

• Severe hepatic impairment (see also section 4.2)

• Seizure disorders

• Recent history of peritonitis in peritoneal dialysis patients

• Serum albumin <30 g/L

Therefore, the use of BindRen is not recommended in patients with these disorders.

Hyperparathyroidism

BindRen alone is not indicated for the control of hyperparathyroidism.

Intestinal obstruction and ileus/subileus

In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with BindRen. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with BindRen. In patients who develop severe constipation or other severe gastrointestinal symptoms, alternative treatment may need to be considered.

Gastrointestinal haemorrhage

Caution should be exercised when treating patients with conditions which predispose to gastrointestinal haemorrhage, such as recent history of gastrointestinal haemorrhage, gastrointestinal ulcers, gastritis, diverticulosis, colitis and haemorrhoids.

Hypocalcaemia/hypercalcaemia

Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. BindRen does not contain calcium, and has no effect on serum calcium concentrations on treatment for up to one year. Serum calcium concentrations should be monitored as a normal follow-up of a dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.

Fat-soluble vitamins

BindRen did not induce any clinically relevant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year. However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption syndromes and patients treated with coumarin anticoagulants (e.g. warfarin). In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.

Folate deficiency

BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year. However, intestinal folate absorption may be impaired during long-term treatment of BindRen. In these patients, monitoring serum folate status and supplementation with folic acid should be considered.

Hypothyroidism

Close monitori