Silodyx

silodosin

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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 Silodyx?

Silodyx is a medicine that contains the active substance silodosin. It is available as capsules (4 and 8 mg).

What is Silodyx used for?

Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults. 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 Silodyx 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.

Silodyx 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 Silodyx work?

The active substance in Silodyx, 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 Silodyx been studied?

The effects of Silodyx were first tested in experimental models before being studied in humans.

Silodyx 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 Silodyx 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 Silodyx shown during the studies?

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

In the two studies where Silodyx 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 Silodyx, 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 Silodyx 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 Silodyx?

The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation. 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. 

For the full list of all side effects and restrictions with Silodyx, see the package leaflet.

Why has Silodyx been approved?

The CHMP decided that Silodyx’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

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

In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.

Other information about Silodyx

The European Commission granted a marketing authorisation valid throughout the European Union for Silodyx on 29 January 2010.

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

Name Language First published Last updated
Silodyx : EPAR - Summary for the public BG = bălgarski 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public ES = español 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public CS = čeština 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public DA = dansk 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public DE = Deutsch 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public ET = eesti keel 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public EL = elliniká 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public EN = English 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public FR = français 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public IT = italiano 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public LV = latviešu valoda 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public LT = lietuvių kalba 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public HU = magyar 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public MT = Malti 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public NL = Nederlands 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public PL = polski 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public PT = português 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public RO = română 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public SK = slovenčina 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public SL = slovenščina 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public FI = suomi 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public SV = svenska 2010-02-22 2014-10-09
Silodyx : EPAR - Summary for the public HR = Hrvatski 2010-02-22 2014-10-09

This EPAR was last updated on 20/04/2015 .

Authorisation details

Product details

Product details for Silodyx
NameSilodyx
Agency product numberEMEA/H/C/001209
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 Silodyx
Marketing-authorisation holder

Recordati Ireland Ltd

Revision11
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

26/02/2015  Silodyx -EMEA/H/C/001209 -WS/0672/G

Name Language First published Last updated
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20
Silodyx : EPAR - Product Information HR = Hrvatski 2010-02-22 2015-04-20

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

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

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
Silodyx : EPAR - Public assessment report HR = Hrvatski 2010-02-22  
CHMP summary of positive opinion for Silodyx HR = Hrvatski 2009-11-19  

Authorised

This medicine is approved for use in the European Union