Emselex

darifenacin hydrobromide

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This is a summary of the European public assessment report (EPAR) for Emselex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emselex.

What is Emselex?

Emselex is a medicine that contains the active substance darifenacin. It is available as prolonged-release tablets (7.5 mg and 15 mg). ‘Prolonged-release’ means that darifenacin is released slowly from the tablet over a few hours.

What is Emselex used for?

Emselex is used in adults with overactive-bladder syndrome. It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.

The medicine can only be obtained with a prescription.

How is Emselex used?

The recommended starting dose of Emselex is 7.5 mg once a day. For patients requiring greater symptom relief, the dose may be increased to 15 mg. The tablets should be swallowed whole with some liquid, and not chewed, divided or crushed.

How does Emselex work?

The active substance in Emselex, darifenacin, is an anticholinergic medicine. It blocks a receptor called the ‘muscarinic M3 receptor’. In the bladder, this causes the muscles that push urine out of the bladder to relax. This leads to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions. This helps Emselex to prevent unwanted urination.

How has Emselex been studied?

Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder. Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (a dummy treatment) or with tolterodine (another medicine used in this condition). The main measure of effectiveness was the change in the number of incontinence episodes per week.

What benefit has Emselex shown during the studies?

When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo. At the start of the studies, the patients had around 16 incontinence episodes per week. After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.

What is the risk associated with Emselex?

The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation. For the full list of all side effects reported with Emselex, see the package leaflet.

Emselex must not be used in people who are hypersensitive (allergic) to darifenacin or any of the other ingredients. It must not be used in patients with:

  • urinary retention (difficulty passing urine);
  • gastric retention (when the stomach does not empty properly);
  • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
  • myasthenia gravis (a disease causing muscle weakness);
  • severe liver problems;
  • severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
  • toxic megacolon (a very serious complication of colitis).

Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).

Why has Emselex been approved?

The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome. The Committee decided that Emselex’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Emselex

The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.

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

Name Language First published Last updated
Emselex : EPAR - Summary for the public BG = bălgarski 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public ES = español 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public CS = čeština 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public DA = dansk 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public DE = Deutsch 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public ET = eesti keel 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public EL = elliniká 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public EN = English 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public FR = français 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public IT = italiano 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public LV = latviešu valoda 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public LT = lietuvių kalba 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public HU = magyar 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public MT = Malti 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public NL = Nederlands 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public PL = polski 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public PT = português 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public RO = română 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public SK = slovenčina 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public SL = slovenščina 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public FI = suomi 2009-09-12 2013-05-24
Emselex : EPAR - Summary for the public SV = svenska 2009-09-12 2013-05-24

This EPAR was last updated on 09/02/2018 .

Authorisation details

Product details

Product details for Emselex
NameEmselex
Agency product numberEMEA/H/C/000554
Active substance

darifenacin hydrobromide

International non-proprietary name (INN) or common name

darifenacin hydrobromide

Therapeutic area Urinary Incontinence, UrgeUrinary Bladder, Overactive
Anatomical therapeutic chemical (ATC) code G04BD10

Publication details

Publication details for Emselex
Marketing-authorisation holder

Merus Labs Luxco S.à R.L.

Revision20
Date of issue of marketing authorisation valid throughout the European Union22/10/2004

Contact address:

Merus Labs Luxco S.à R.L.
26-28 rue Edward Steichen
L-2540 Luxembourg

Product information

Product information

19/12/2017  Emselex -EMEA/H/C/000554 -IB/0064

Name Language First published Last updated
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09
Emselex : EPAR - Product Information SV = svenska 2008-09-08 2018-02-09

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
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  
Emselex : EPAR - All Authorised presentations SV = svenska 2006-11-16  

Pharmacotherapeutic group

Urinary antispasmodics

Therapeutic indication

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Emselex : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-09-08 2018-02-09

Initial marketing-authorisation documents

Name Language First published Last updated
Emselex : EPAR - Procedural steps taken before authorisation SV = svenska 2006-01-19  
Emselex : EPAR - Scientific Discussion SV = svenska 2006-01-19  

Authorised

This medicine is approved for use in the European Union