Silodyx - silodosin

What is Silodyx?

Silodyx is a medicine that contains the active substance silodosin and is available in capsules (yellow
4 mg and white 8 mg).

What is Silodyx used for?

Silodyx 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 Silodyx 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. Silodyx 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 Silodyx work?

The active ingredient of Silodyx, silodosin, is an alpha-adrenergic receptor antagonist, that is, it works 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, thus facilitating the passage of urine, improving 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 was 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 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 Silodyx shown during the studies?

Silodyx was more effective than placebo and as effective as tamsulosin in reducing symptoms of BPH. In the two studies comparing Silodyx 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 Silodyx 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 Silodyx 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 Silodyx?

The most common side effect associated with Silodyx (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 Silodyx, see the package leaflet.
Silodyx 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 Silodyx been approved?

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

Learn more about Silodyx

On 29 January 2010, the European Commission granted Recordati Ireland Ltd. a "marketing authorization" for Silodyx, valid throughout the European Union. This authorization is valid for five years and is renewable.
For the full version of the Silodyx EPAR, click here.
Last update of this summary: 12-2009.

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