Elements for a Public Summary

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1 Fresenius Medical Care Page 66/71 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Sorbisterit is indicated for treatment of hyperkalaemia in patients with acute and chronic renal insufficiency, including patients undergoing dialysis treatment. Hyperkalaemia might result from impaired potassium excretion in patients with decreased renal function. It may also occur during inappropriate use of potassium supplements, during rapid intravenous (i.v.) administration of potassium-containing solutions and for other metabolic reasons (particularly hyperglycaemia). About 90% of the daily potassium intake is excreted in the urine, and 10% in the stools. Due to the reduced renal function, hyperkalaemia is a common event in patients suffering from chronic kidney disease. Whereas mild hyperkalaemia (potassium level of less than 6.5 mmol/l) normally does not produce any clinical signs, moderate hyperkalaemia (ranging from mmol/l) is usually accompanied by minor electrocardiogram (ECG) changes. Severe hyperkalaemia is usually defined as a serum potassium level increased above 8.0 mmol/l, with significant ECG changes. It is associated with altered bioelectric responses by causing de-polarisation of excitable cells. High serum concentrations of potassium may thus cause life-threatening cardiac depression, arrhythmia or arrest. In skeletal muscle hyperkalaemia leads to muscle weakness that can eventuate in paralysis. VI.2.2 Summary of treatment benefits The treatment benefit is to prevent high serum concentrations of potassium which may cause lifethreatening cardiac depression, arrhythmia or arrest as well as skeletal muscle involvement such as muscle weakness which can lead to paralysis. VI.2.3 Unknowns relating to treatment benefits The product is well known and the use is well established. During years of experience and in several clinical investigations, polystyrene sulfonate has shown to be very effective in maintaining serum potassium levels in normal ranges. At this point in time there are no gaps in the knowledge about efficacy in the target population

2 Fresenius Medical Care Page 67/71 VI.2.4 Summary of safety concerns Important identified risks Table 16 What is known Preventability Increased blood calcium levels (Hypercalcaemia) Decrease in blood potassium levels (Hypokalaemia) Decrease in blood magnesium levels (Hypomagnesaemia) Nausea and Vomiting potassium uptake. Therefore it may happen that too much calcium is released because the dose was too high. High calcium levels may lead to serious heart problems. potassium uptake. Therefore it may happen that too much calcium is released and therefore too much potassium has been extracted from the body. The reason may be that the dose was too high. Low potassium levels may lead to serious heart and muscular problems. potassium uptake. However, the product might not exchange calcium with potassium but bind magnesium instead. This could lead for instance to muscular problems, fatigue, palpitation or restlessness. Nausea and vomiting occurs probable as gastrointestinal reaction to the large amount of the medicinal product to be swallowed and passing through the gastrointestinal tract. calcium levels are necessary to ensure that the blood calcium levels are within the tolerated ranges. potassium levels are necessary to ensure that the blood potassium levels are within the tolerated ranges. magnesium levels are necessary to ensure that the blood magnesium levels are within the tolerated ranges. Sorbisterit should be taken with food.

3 Fresenius Medical Care Page 68/71 What is known Preventability Obstructive bowel disease Pre-existing or acquired obstructions may cause barriers which interfere with Sorbisterit s passage through the intestinal tract. As it is not dissolvable it will not be absorbed nor removed and can therefore affect the intestinal tissue. Sorbisterit should not be used in patients who suffer from obstructive bowel disease. To ensure that the treating physicians are aware of it, a warning statement is placed in the product information. Important potential risks Galactose malabsorption, sucraseisomaltase deficiency (Sorbisterit ) Oral application in neonates with reduced gut motility Overdosing Off label use What is known (Including reason why it is considered a potential risk) No administration of products containing the above mentioned agents. A warning is provided in the current SmPC for Sorbisterit in the section 4.4 Special warning and precautions for use. The above stated condition has only impact on a low number of patients. The symptoms of these conditions may vary (no to severe toxic symptoms). The oral route of administration is not recommended for neonates. Children and neonates may be given rectal doses similar to those suggested for children by mouth. Overdosing may lead to low potassium blood levels and low potassium levels may lead to serious heart and muscular problems. Detailed dosing instructions are given by the prescribing physician. The product is only indicated for renal impaired patients. In this population controls of serum potassium levels are routine practice. Over- or underdosing of Sorbisterit will therefore soon be detected. The company explicitly points out in the SmPC that serum potassium levels have to be controlled daily. Sorbisterit should not be used as only therapy for the treatment of acute increase of blood potassium. However, a warning has been placed in the product information that Sorbisterit is not sufficiently effective in these cases. The treating physicians are requested to use other therapy options Important missing information What is known

4 Fresenius Medical Care Page 69/71 There are no data on the use of calcium polystyrene sulphonate during pregnancy. No data is available on the use of calcium polystyrene sulphonate by women who are breast-feeding. What is known The potential risk for humans is unknown. Sorbisterit should not be used during pregnancy unless clearly necessary. Sorbisterit should not be used during breast-feeding unless strictly necessary. VI.2.5 Summary of risk minimisation measures by safety concern None proposed. The product is well known and the use is well established. The product is marketed for many years and the above stated risk is already listed in the current SmPC. VI.2.6 Planned post authorisation development plan No post authorisation development plan is required as the product is well known and the use is well established. VI.2.7 Summary of changes to the over time Not applicable as this is the first RMP for the products concerned.

5 Fresenius Medical Care Page 70/71 Literature: 2010 Annual Report of the Dialysis Outcomes and Practice Patterns Study: Hemodialysis Data Arbor Research Collaborative for Health, Ann Arbor, MI. Agarwal R, et al. Gastroenterology. 1994;107: De Francisco ALM, et al. Nephron Clin Pract. 2011;118:c143-c154 Evans KJ & Greenberg A. J Intensive Care Med. 2005;20: Hayes J, et al. Nephron Clin Pract. 2012;120:c8-c16 Hecking E, et al. Nephrol Dial Transplant. 2004;19: Kleophas W, et al. Clin Nephrol. 2013;79: Korgaonkar S, et al. Clin J Am Soc Nephrol. 2012;5: Kovesdy CP, et al. Clin J Am Soc Nephrol. 2007;2: Sarafidis PA, et al. Clin J Am Soc Nephrol. 2012;7: Stevens LA, et al. Am J Kidney Dis. 2010;55(Suppl2):S23-S33

PHOSPHATE-SANDOZ Tablets (High dose phosphate supplement)

1 PHOSPHATE-SANDOZ Tablets (High dose phosphate supplement) PHOSPHATE-SANDOZ PHOSPHATE-SANDOZ Tablets are a high dose phosphate supplement containing sodium phosphate monobasic. The CAS registry number