Nexium Control

esomeprazole

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

For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.

What is Nexium Control and what is it used for?

Nexium Control is a medicine that contains the active substance esomeprazole. It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.

Nexium Control is similar to a ‘reference medicine’ already authorised in the European Union (EU) containing the same active substance, called Nexium. The reference medicine is only available with a prescription, but Nexium Control is intended for short-term use without a prescription.

How is Nexium Control used?

Nexium Control can be obtained without a prescription. It is available as tablets (20 mg) which are gastroresistant (the contents pass through the stomach without being broken down until they reach the intestine). The recommended dose is one tablet per day for up to two weeks until the symptoms are relieved. If symptoms persist after two weeks, the patient should see a doctor. For further information, see the package leaflet.

How does Nexium Control work?

The active substance in Nexium Control, esomeprazole, is a proton-pump inhibitor. It works by blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining, which pump acid into the stomach. By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.

What benefits of Nexium Control have been shown in studies?

Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn. The patients were treated for four weeks. The main measure of effectiveness in both studies was the percentage of patients whose heartburn symptoms had completely cleared up at the end of the study.

In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124). In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118). In both studies, most patients whose symptoms completely cleared up had already achieved this in the first two weeks, while patients whose symptoms did not completely clear up in two weeks showed little further improvement from continued treatment.

What are the risks associated with Nexium Control?

Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients). For the full list of all side effects reported with Nexium Control, see the package leaflet.

Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection). For the full list of restrictions, see the package leaflet.

Why is Nexium Control approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine’s effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients’ symptoms cleared up in two weeks. The Committee concluded that patients could safely treat themselves with the medicine for up to two weeks.

What measures are being taken to ensure the safe and effective use of Nexium Control?

A risk management plan has been developed to ensure that Nexium Control 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 Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Nexium Control

The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.

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

Name Language First published Last updated
Nexium Control : EPAR - Summary for the public BG = bălgarski 19/09/2013  
Nexium Control : EPAR - Summary for the public ES = español 19/09/2013  
Nexium Control : EPAR - Summary for the public CS = čeština 19/09/2013  
Nexium Control : EPAR - Summary for the public DA = dansk 19/09/2013  
Nexium Control : EPAR - Summary for the public DE = Deutsch 19/09/2013  
Nexium Control : EPAR - Summary for the public ET = eesti keel 19/09/2013  
Nexium Control : EPAR - Summary for the public EL = elliniká 19/09/2013  
Nexium Control : EPAR - Summary for the public EN = English 19/09/2013  
Nexium Control : EPAR - Summary for the public FR = français 19/09/2013  
Nexium Control : EPAR - Summary for the public IT = italiano 19/09/2013  
Nexium Control : EPAR - Summary for the public LV = latviešu valoda 19/09/2013  
Nexium Control : EPAR - Summary for the public LT = lietuvių kalba 19/09/2013  
Nexium Control : EPAR - Summary for the public HU = magyar 19/09/2013  
Nexium Control : EPAR - Summary for the public MT = Malti 19/09/2013  
Nexium Control : EPAR - Summary for the public NL = Nederlands 19/09/2013  
Nexium Control : EPAR - Summary for the public PL = polski 19/09/2013  
Nexium Control : EPAR - Summary for the public PT = português 19/09/2013  
Nexium Control : EPAR - Summary for the public RO = română 19/09/2013  
Nexium Control : EPAR - Summary for the public SK = slovenčina 19/09/2013  
Nexium Control : EPAR - Summary for the public SL = slovenščina 19/09/2013  
Nexium Control : EPAR - Summary for the public FI = suomi 19/09/2013  
Nexium Control : EPAR - Summary for the public SV = svenska 19/09/2013  
Nexium Control : EPAR - Summary for the public HR = Hrvatski 19/09/2013  

This EPAR was last updated on 28/01/2016 .

Authorisation details

Product details

Product details for Nexium Control
NameNexium Control
Agency product numberEMEA/H/C/002618
Active substance

esomeprazole

International non-proprietary name (INN) or common name

esomeprazole

Therapeutic area Gastroesophageal Reflux
Anatomical therapeutic chemical (ATC) code A02BC05

Publication details

Publication details for Nexium Control
Marketing-authorisation holder

Pfizer Consumer Healthcare Ltd

Revision7
Date of issue of marketing authorisation valid throughout the European Union26/08/2013

Contact address:

Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

23/11/2015  Nexium Control -EMEA/H/C/002618 -IB/0014

Name Language First published Last updated
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016
Nexium Control : EPAR - Product Information HR = Hrvatski 19/09/2013 28/01/2016

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
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013
Nexium Control : EPAR - All Authorised presentations HR = Hrvatski 19/09/2013 19/11/2013

Pharmacotherapeutic group

Proton-pump inhibitors

Therapeutic indication

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nexium Control : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 08/11/2013 28/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Nexium Control : EPAR - Public assessment report HR = Hrvatski 19/09/2013  
CHMP summary of positive opinion for Nexium Control HR = Hrvatski 28/06/2013  

Authorised

This medicine is approved for use in the European Union