pine). In the subjects over 65 years, the mean decreases at the various time points were between 5 and 15 mmHg (systolic) and 0 and 10 mmHg (diastolic). Positive orthostatic tests were only slightly more common during co-administration; however, no symptomatic orthostasis or dizziness occurred. Patients taking PDE5 inhibitors concomitantly with Urorec should be monitored for possible adverse reactions.
Antihypertensives
In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the reninangiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension. Nevertheless, caution should be exercised when starting concomitant use with antihypertensives and patients should be monitored for possible adverse reactions.
Digoxin
Steady state levels of digoxin, a substrate of Pglycoprotein, were not significantly affected by coadministration with silodosin 8 mg once daily. No dose adjustment is required.
4.6 Pregnancy and lactation
Pregnancy and lactation
Not applicable as Urorec is intended for male patients only.
Fertility
In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with Urorec (see section 4.8), due to the pharmacodynamic properties of silodosin. Before starting treatment, the patient should be informed that this effect may occur, temporarily affecting male fertility.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how Urorec will affect them.
4.8 Undesirable effects
The safety of Urorec has been eva luated in four double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies. In total, 1,581 patients have received silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year.
The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23 %. This may temporarily affect male fertility. It is reversible within a few days upon discontinuation of treatment (see section 4.4).
In the table below, adverse reactions reported in all clinical studies and for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from available data). Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
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Very common
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Common
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Uncommon
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Not known
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Psychiatric disorders
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