Sevelamer carbonate Zentiva

sevelamer carbonate

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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 a medicine used to control hyperphosphataemia (high blood phosphate levels) in:

  • adult patients on dialysis (a technique to remove unwanted substances from the blood);
  • adults and children from 6 years of age with chronic (long-term) kidney disease.

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

It contains the active substance sevelamer carbonate.

How is Sevelamer carbonate Zentiva used?

Sevelamer carbonate Zentiva is available as tablets (800 mg) and as powder (2.4 g) in a sachet to be taken three times a day with meals.

The dose to take depends on the patient’s level of blood phosphate and, in case of children, their height and weight. Sevelamer carbonate Zentiva must not be taken on an empty stomach and patients should keep to their prescribed diets.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Sevelamer carbonate Zentiva work?

The active substance in Sevelamer carbonate Zentiva, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.

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

Sevelamer carbonate Zentiva has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.

In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Zentiva brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.

In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Zentiva reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.

Finally, a main study also showed that Sevelamer carbonate Zentiva was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Zentiva had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.

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 (belly) pain and constipation. For the full list of all side effects reported with Sevelamer carbonate Zentiva, see the package leaflet.

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

Why is Sevelamer carbonate Zentiva approved?

Studies show that Sevelamer carbonate Zentiva is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable. The European Medicines Agency therefore concluded that Sevelamer carbonate Zentiva’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Zentiva have been included in the summary of product characteristics and the package leaflet.

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. This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent’).

For more information about treatment with Sevelamer carbonate Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Sevelamer carbonate Zentiva : EPAR - Summary for the public BG = bălgarski 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public ES = español 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public CS = čeština 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public DA = dansk 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public DE = Deutsch 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public ET = eesti keel 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public EL = elliniká 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public EN = English 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public FR = français 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public IT = italiano 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public LV = latviešu valoda 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public LT = lietuvių kalba 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public HU = magyar 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public MT = Malti 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public NL = Nederlands 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public PL = polski 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public PT = português 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public RO = română 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public SK = slovenčina 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public SL = slovenščina 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public FI = suomi 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public SV = svenska 2015-03-13 2017-07-26
Sevelamer carbonate Zentiva : EPAR - Summary for the public HR = Hrvatski 2015-03-13 2017-07-26

This EPAR was last updated on 13/11/2017 .

Authorisation details

Product details

Product details for Sevelamer carbonate Zentiva
NameSevelamer carbonate Zentiva
Agency product numberEMEA/H/C/003971
Active substance

sevelamer carbonate

International non-proprietary name (INN) or common name

sevelamer carbonate

Therapeutic area HyperphosphatemiaRenal Dialysis
Anatomical therapeutic chemical (ATC) code V03AE02

Publication details

Publication details for Sevelamer carbonate Zentiva
Marketing-authorisation holder

Genzyme Europe BV

Revision8
Date of issue of marketing authorisation valid throughout the European Union15/01/2015

Contact address:

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
The Netherlands

Product information

Product information

22/09/2017  Sevelamer carbonate Zentiva -EMEA/H/C/003971 -IG/0844

Name Language First published Last updated
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13
Sevelamer carbonate Zentiva : EPAR - Product Information HR = Hrvatski 2015-03-13 2017-11-13

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04
Sevelamer carbonate Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2015-03-13 2015-06-04

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.

Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.

Sevelamer carbonate Zentiva should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Sevelamer carbonate Zentiva : EPAR - Public assessment report HR = Hrvatski 2015-03-13  
CHMP summary of positive opinion for Sevelamer carbonate Zentiva HR = Hrvatski 2014-11-21