What is Urorec?
Urorec is a medicine that contains the active substance silodosin and is available in capsules (yellow 4 mg and white 8 mg).
What is Urorec used for?
Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH), which is an increase in the size of the prostate. The prostate is an organ found in males at the base of the bladder that, when it gets bigger, creates 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 per day. For patients with moderate kidney problems the starting dose is 4 mg once a day, then eventually increased to 8 mg once a day after one week. Urorec is not recommended for patients with severe kidney problems.
The capsules should be taken with food and preferably at the same time each day; they should be swallowed whole, possibly with a glass of water.
How does Urorec work?
The active ingredient of Urorec, silodosin, is an antagonist of alpha-adrenergic receptors or acts by blocking the alpha1A adrenergic receptors inside the prostate, bladder and urethra (the duct that departs from the bladder and opens to the " The activation of the receptors involves the contraction of the muscles that control the outflow of urine. They block the receptors, the silodosin induces a relaxation of this muscles, therefore facilitates the passage of urine, improving 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 BPH drug). The main measure of effectiveness of all three studies was the improvement in the patients' International Prostate Score (IPSS) after 12 weeks of treatment. IPSS is a parameter for classifying patient symptoms, such as the inability to evacuate the bladder and the urge to urinate repeatedly or the need to strain to urinate. The assessment of the severity of symptoms was done by the patients themselves.
What benefit has Urorec shown during the studies?
Urorec was more effective than placebo and as effective as tamsulosin in reducing symptoms of BPH. In the two studies comparing Urorec with placebo alone, the IPSS was about 21 points at the start of the study and then dropped afterwards. 12 weeks, about 6.4 points in patients treated with Urorec and about 3.5 points in patients treated with placebo. In the third study the starting IPSS was about 19 points, then down by 7.0 points in patients treated with Urorec for 12 weeks, by 6.7 points in patients treated with tamsulosin and by 4.7 points in patients treated with placebo.
What are the risks associated with Urorec?
The most common side effect associated with Urorec (ie seen in more than 1 in 10 patients) is a reduction in the amount of semen released by ejaculation. For the full list of side effects reported with Urorec, see the package leaflet.
Urorec should not be used in patients who may be hypersensitive (allergic) to silodosin or any of the other ingredients.
In some patients the antagonists of alpha-adrenergic receptors can give rise to the so-called intraoperative flag iris syndrome (IFIS), therefore to possible complications during cataract surgery. This is an event that makes the iris weak.
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 authorization.
More information about Urorec
On 29 January 2010, the European Commission granted Recordati Ireland Ltd. a "marketing authorization" for Urorec, valid throughout the European Union. This authorization is valid for five years and is renewable.
For the full version of Urorec's EPAR, click here
Last update of this summary: 12-2009.
The information on Urorec published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
