Urorec

silodosin

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Urorec?

Urorec is a medicine that contains the active substance silodosin. It is available as capsules (yellow: 4 mg; white: 8 mg).

What is Urorec used for?

Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland). The prostate gland is an organ found at the base of the bladder in men. When enlarged, it can cause problems with the flow of urine.

The medicine can only be obtained with a prescription.

How is Urorec used?

The recommended dose is one 8-mg capsule once a day. For men with moderate kidney problems, the starting dose should be 4 mg once a day. This may be increased to 8 mg once a day after a week.

Urorec is not recommended for patients with severe kidney problems.

The capsules should be taken with food, preferably at the same time every day. They should be swallowed whole, preferably with a glass of water.

How does Urorec work?

The active substance in Urorec, silodosin, is an alpha-adrenoreceptor antagonist. It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body). When these receptors are activated, they cause the muscles controlling the flow of urine to contract. By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.

How has Urorec been studied?

The effects of Urorec were first tested in experimental models before being studied in humans. Urorec has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH. One of these studies also compared Urorec with tamsulosin (another medicine used for BPH).

The main measure of effectiveness in all three studies was the improvement of the patients’ international prostate symptom score (IPSS) after 12 weeks of treatment. IPSS is a rating of the patient’s symptoms such as the inability to empty the bladder, and the urge to urinate repeatedly or to strain while urinating. The patients rated the severity of their symptoms themselves.

What benefit has Urorec shown during the studies?

Urorec was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.

In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study. After 12 weeks, it had fallen by around 6.4 points in the men who took Urorec, and by around 3.5 points in the men who took placebo. In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Urorec after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.

What is the risk associated with Urorec?

The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation. For the full list of all side effects reported with Urorec, see the package leaflet.

Urorec should not be used in people who may be hypersensitive (allergic) to silodosin or any of the other ingredients.

Intra-operative floppy iris syndrome (IFIS) occurs in some patients taking alpha-adrenoreceptor antagonists and may lead to complications during cataract surgery. IFIS is a condition that makes the iris floppy.

Why has Urorec been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Urorec’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Urorec?

The company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.

Other information about Urorec

The European Commission granted a marketing authorisation valid throughout the European Union for Urorec to Recordati Ireland Ltd. on 29 January 2010. The marketing authorisation is valid for five years, after which it can be renewed.

Name Language First published Last updated
Urorec : EPAR - Summary for the public BG = bălgarski 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public ES = español 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public CS = čeština 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public DA = dansk 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public DE = Deutsch 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public ET = eesti keel 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public EL = elliniká 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public EN = English 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public FR = français 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public IT = italiano 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public LV = latviešu valoda 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public LT = lietuvių kalba 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public HU = magyar 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public MT = Malti 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public NL = Nederlands 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public PL = polski 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public PT = português 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public RO = română 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public SK = slovenčina 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public SL = slovenščina 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public FI = suomi 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public SV = svenska 22/02/2010 08/10/2014
Urorec : EPAR - Summary for the public HR = Hrvatski 22/02/2010 08/10/2014

This EPAR was last updated on 20/04/2016 .

Authorisation details

Product details

Product details for Urorec
NameUrorec
Agency product numberEMEA/H/C/001092
Active substance

silodosin

International non-proprietary name (INN) or common name

silodosin

Therapeutic area Prostatic Hyperplasia
Anatomical therapeutic chemical (ATC) code G04CA04

Publication details

Publication details for Urorec
Marketing-authorisation holder

Recordati Ireland Ltd

Revision12
Date of issue of marketing authorisation valid throughout the European Union29/01/2010

Contact address:

Recordati Ireland Ltd
Raheens East
Ringaskiddy, Co. Cork
Ireland

Product information

Product information

26/02/2016  Urorec -EMEA/H/C/001092 -N/0024

Name Language First published Last updated
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016
Urorec : EPAR - Product Information HR = Hrvatski 22/02/2010 20/04/2016

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
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  
Urorec : EPAR - All Authorised presentations HR = Hrvatski 22/02/2010  

Name Language First published Last updated
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  
Urorec : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 22/02/2010  

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Urorec : EPAR - Public assessment report HR = Hrvatski 22/02/2010  
CHMP summary of positive opinion for Urorec HR = Hrvatski 19/11/2009  

Authorised

This medicine is approved for use in the European Union