Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.

Fertility

No data are available to assess the potential influence of BindRen on fertility.
4.7 Effects on ability to drive and use machines
 BindRen has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
 Summary of the safety profile

The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population. Patients received doses of up to 15 g per day, in three divided doses of 5 g.

Approximately 30% of patients experienced at least one adverse reaction. The most serious adverse reactions were gastrointestinal haemorrhage (uncommon) and constipation (common). The most frequently reported adverse reactions were nausea, dyspepsia and vomiting (all common). The frequency of adverse reactions increased with dose.

Tabulated list of adverse reactions

A tabulated list of frequencies was defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Infections and infestations
  
Uncommon:
 Gastroenteritis
 
Endocrine disorders
  
Uncommon:
 Hyperparathyroidism
 
Metabolism and nutrition disorders
  
Common:
 Hypocalcaemia, decreased appetite
 
Uncommon:
 Folate deficiency, hypertriglyceridaemia, polydipsia
 
Rare:
 Vitamin K deficiency, calciphylaxis, electrolyte imbalance, fluid overload
 
Psychiatric disorders
  
Uncommon:
 Insomnia
 
Nervous system disorders
  
Uncommon:
 Tremor, dizziness, headache, dysgeusia
 
Cardiac disorders
  
Rare:
 Coronary artery disease
 
Vascular disorders
  
Uncommon:
 Haematoma, hypotension
 
Gastrointestinal disorders
  
Common:
 Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
 
Uncommon:
 Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
 
Rare:
 Intestinal obstruction*
 
Hepatobiliary disorders
  
Uncommon:
 Hepatic enzymes increased
 
Skin and subcutaneous tissue disorders
  
Uncommon:
 Urticaria, rash, pruritus, dry skin
 
Rare:
 Allergic dermatitis, guttae psoriasis
 
Musculoskeletal and connective tissue disorders
  
Uncommon:
 Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
 
General disorders and administration site conditions
  
Uncommon:
 Asthenia

*A single case with