What is Silodyx?
Silodyx is a medicine that contains the active substance silodosin and is available in capsules (yellow
from 4 mg and white from 8 mg).
What is Silodyx used for?
Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH), which is an increase in prostate size. The prostate is an organ present in males at the base of the bladder that, when it swells, creates problems in the outflow 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, and then possibly change 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 and preferably at the same time each day; they should be swallowed whole with a glass of water if possible.
How does Silodyx work?
The active substance in Silodyx, silodosin, is an alpha-adrenergic receptor antagonist or it works by blocking alpha1A adrenergic receptors inside the prostate, bladder and urethra (the conduit that starts from the bladder and opens to the outside of the body). The activation of the receptors involves the contraction of the musculature that controls the outflow of the urine. They block the receptors, the silodosin induces a relaxation of this musculature, therefore it facilitates the passage of the urine improving the symptoms of the 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 a placebo (a dummy treatment) in the three main studies involving over 1800 men with BPH. One of these studies also compared Silodyx with tamsulosin (another drug against BPH). The main efficacy parameter of all three studies was the improvement of patients' international prostate score (IPSS) after 12 weeks of treatment. IPSS is a parameter for classifying the patient's symptoms, such as the inability to evacuate the bladder and the urgent urge to urinate repeatedly or the need to strain to urinate. The evaluation of symptom severity was carried out 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 the symptoms of BPH. In the two comparison studies of Silodyx with placebo alone, the IPSS was about 21 points at the beginning of the study and then dropped, after 12 weeks, by 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 dropped by 7.0 points in patients treated with Silodyx for 12 weeks, 6.7 points in patients treated with tamsulosin and 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 all 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 alpha-adrenergic receptor antagonists may give rise to the so-called intraoperative flag iris syndrome (IFIS), thus to possible complications during cataract surgery. This is an event that affects the iris.
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.
More information on Silodyx
On 29 January 2010, the European Commission issued a marketing authorization valid throughout the EU for Silodyx to Recordati Ireland Ltd. This authorization is valid for five years and is renewable.
The full EPAR for Silodyx can be found here.
Last update of this summary: 12-2009.
