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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/733102/2014

EMEA/H/C/003971

EPAR summary for the public

Sevelamer carbonate Zentiva

sevelamer carbonate

This is a summary of the European public assessment report (EPAR) for Sevelamer carbonate Zentiva. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Sevelamer carbonate Zentiva.

For practical information about using Sevelamer carbonate Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.

What is Sevelamer carbonate Zentiva and what is it used for?

Sevelamer carbonate Zentiva is used to control hyperphosphataemia (high blood phosphate levels) in:

•    adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).

•    adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.

Sevelamer carbonate Zentiva should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.

Sevelamer carbonate Zentiva contains the active substance sevelamer carbonate. This medicine is the same as Renvela, which is already authorised in the European Union (EU). The company that makes Renvela has agreed that its scientific data can be used for Sevelamer carbonate Zentiva ('informed consent').

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How is Sevelamer carbonate Zentiva used?

Sevelamer carbonate Zentiva is available as tablets (800 mg) and as a powder (2.4 g) to be made up into a suspension to be taken by mouth. The medicine can only be obtained with a prescription.

The recommended starting dose of Sevelamer carbonate Zentiva depends on the clinical need and the level of phosphate in the blood, and ranges from 2.4 to 4.8 g per day. Sevelamer carbonate Zentiva must be taken three times a day with meals and patients should keep to their prescribed diets.

The dose of Sevelamer carbonate Zentiva should be adjusted every two to four weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly. The tablets should be taken whole and the suspension should be taken within 30 minutes of being prepared.

How does Sevelamer carbonate Zentiva work?

Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to phosphate accumulating in the body, which, in the long term, can cause complications such as heart disease. The active substance in Sevelamer carbonate Zentiva, sevelamer carbonate, is a phosphate binder. When taken with meals, the sevelamer molecules in sevelamer carbonate attach to phosphate from food within the gut, preventing it from being absorbed into the body. This helps to reduce the phosphate levels in the blood.

What benefits of Sevelamer carbonate Zentiva have been shown in studies?

Sevelamer carbonate Zentiva has been shown to be as effective as another medicine, Renagel (which also contains sevelamer but as the hydrochloride salt) in reducing blood phosphate levels in patients with chronic kidney disease who were on dialysis. In two crossover studies, 110 patients (who had all previously taken oral phosphate binder treatment, and most of whom took vitamin D) were treated for four or eight weeks with either Sevelamer carbonate Zentiva or Renagel, and then had their treatment switched. In the two studies, the average amount of phosphate in the blood during treatments with Sevelamer carbonate Zentiva or Renagel was similar.

Another study looked at the effect of Sevelamer carbonate Zentiva in 49 patients with high blood phosphate levels (equal to or above 1.78 mmol/l) who were not on dialysis. After eight weeks of treatment, the average amount of phosphate in the blood was reduced by about a fifth, from 2.0 mmol/l to 1.6 mmol/l.

What are the risks associated with Sevelamer carbonate Zentiva?

The most common side effects with Sevelamer carbonate Zentiva (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, upper abdominal pain (stomach ache) and constipation.

Sevelamer carbonate Zentiva must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut). For the full list of all side effects and restrictions with Sevelamer carbonate Zentiva, see the package leaflet.

Why is Sevelamer carbonate Zentiva approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sevelamer carbonate Zentiva's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that treatment with Sevelamer carbonate Zentiva has a beneficial effect in lowering blood phosphate levels without major safety concerns. Although the Committee noted that the study in patients not on dialysis was small, it concluded that the medicine can also be used in

Sevelamer carbonate Zentiva

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these patients because they have the same underlying disease as those on dialysis and therefore similar effectiveness can be expected.

What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Zentiva?

A risk management plan has been developed to ensure that Sevelamer carbonate Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sevelamer carbonate Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Sevelamer carbonate Zentiva will make sure that educational material is available in all Member States for patients and healthcare professionals. This material will include information on the risk and prevention of peritonitis (inflammation of the lining of the abdomen) in patients undergoing peritoneal dialysis, arterio-venous fistula (an abnormal passageway between an artery and a vein) in patients undergoing haemodialysis, and vitamin deficiency in patients with chronic kidney disease.

Other information about Sevelamer carbonate Zentiva

The European Commission granted a marketing authorisation valid throughout the European Union for Sevelamer carbonate Zentiva on 15 January 2015.

The full EPAR for Sevelamer carbonate Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Sevelamer carbonate Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2015.

Sevelamer carbonate Zentiva EMA/733102/2014