Urorec | European Medicines Agency (EMA)

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Overview

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).

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

English (EN)
(73.61 KB – PDF)

First published: 22/02/2010Last updated: 08/10/2014

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Product information

English (EN)
(261.09 KB – PDF)

First published: 22/02/2010Last updated: 05/02/2025

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Latest procedure affecting product information:
N/0060

04/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(12.61 KB – PDF)

First published: 22/02/2010Last updated: 22/02/2010

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English (EN)
(72.53 KB – PDF)

First published: 22/02/2010Last updated: 22/02/2010

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Product details

Name of medicine: Urorec
Active substance: silodosin
International non-proprietary name (INN) or common name: silodosin
Therapeutic area (MeSH): Prostatic Hyperplasia
Anatomical therapeutic chemical (ATC) code: G04CA04

Pharmacotherapeutic group

Urologicals

Therapeutic indication

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

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