SEVELAMER HYDROCHLORIDE

8 g per day based on clinical needs and serum phosphorus level. Sevelamer Hydrochloride must be taken three times per day with meals. 5 mg/dl) 2 tablets, 3 times per day For patients previously on phosphate binders, Sevelamer Hydrochloride should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.

5 mg/dl) or less. Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter. The dose range may vary between 1 and 5 tablets of 800 mg per meal. The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.

Paediatric population The safety and efficacy of this product have not been established in patients below the age of 18 years. Renal impairment The safety and efficacy of this product have not been established in predialysis patients.

Method of administration For oral use. Patients should take Sevelamer Hydrochloride with meals and adhere to their prescribed diets. The tablets must be swallowed whole. Do not crush, chew or break into pieces prior to administration.

Summary of the safety profile The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class. Tabulated list of adverse reactions Parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted.

Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients), and that were spontaneously reported from post- marketing experience are listed by frequency in the table below. The reporting rate is classified as 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), not known (cannot be estimated form the available data).

4 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Efficacy and safety of Sevelamer Hydrochloride has not been studied in patients with: • swallowing disorders • active inflammatory bowel disease • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis retention of gastric contents and abnormal or irregular bowel motion • patients with a history of major gastrointestinal surgery Therefore caution should be exercised when Sevelamer Hydrochloride is used in patients with these disorders.

Intestinal obstruction and ileus/subileus In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with sevelamer hydrochloride.

Sevelamer Hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms. Fat-soluble vitamins Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.

It cannot be excluded that Sevelamer Hydrochloride can bind fat-soluble vitamins contained in ingested food. Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.

Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients. Folate deficiency There is at present insufficient data to exclude the possibility of folate deficiency during long term Sevelamer Hydrochloride treatment.

Hypocalcaemia/hypercalcaemia Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. Sevelamer Hydrochloride does not contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.

Elemental calcium should be given as a supplement in case of hypocalcaemia. Metabolic acidosis Patients with chronic renal failure are predisposed to developing metabolic acidosis. Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.

Closer monitoring of serum bicarbonate levels is therefore recommended. Peritonitis Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality. Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Sevelamer Hydrochloride, a number of peritonitis cases were reported.

Therefore, patients on PD should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis. Swallowing and choking difficulties Uncommon reports of difficulty swallowing the Sevelamer hydrochloride tablet have been reported.

Many of these cases involved patients with co- morbid conditions including swallowing disorders or oesophageal abnormalities. Caution should be exercised when Sevelamer Hydrochloride is used in patients with difficulty swallowing. 5).

2). Hyperparathyroidism Sevelamer Hydrochloride alone is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism Sevelamer Hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25- dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.

Serum chloride Serum chloride may increase during Sevelamer Hydrochloride treatment as chloride may be exchanged for phosphorus in the intestinal lumen. Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient.

1 mEq) chloride. Inflammatory disorders may resolve upon sevelamer discontinuation. Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms. Excipient warnings in the formulation Sevelamer Hydrochloride tablets contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

1. • Hypophosphataemia • Bowel obstruction.