ry has been recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet been established.
During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with Urorec, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Orthostatic effects
The incidence of orthostatic effects with Urorec is very low. However, a reduction in blood pressure can occur in individual patients, leading in rare cases to syncope. At the first signs of orthostatic hypotension (such as postural dizziness), the patient should sit or lie down until the symptoms have disappeared. In patients with orthostatic hypotension, treatment with Urorec is not recommended.
Renal impairment
The use of Urorec in patients with severe renal impairment (CLCR <30 ml/min) is not recommended (see sections 4.2 and 5.2).
Hepatic impairment
Since no data are available in patients with severe hepatic impairment, the use of Urorec in these patients is not recommended (see sections 4.2 and 5.2).
Carcinoma of the prostate
Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with Urorec, to rule out the presence of carcinoma of the prostate. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
Treatment with Urorec leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility. This effect disappears after discontinuation of Urorec (see section 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7. Silodosin is also a substrate for P-glycoprotein. Substances that inhibit or induce these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Alpha-blockers
There is inadequate information about the safe use of silodosin in association with other αadrenoreceptor antagonists. Consequently, the concomitant use of other αadrenoreceptor antagonists is not recommended.
CYP3A4 inhibitors
In an interaction study, a 3.7fold increase in maximum silodosin plasma concentrations and a 3.1fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg). Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole or ritonavir) is not recommended.
When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30 % was observed, but Cmax and half-life were not affected. This change is clinically not relevant and no dose adjustment is required.
PDE5 inhibitors
Minimal pharmacodynamic interactions have been observed between silodosin and maximum doses of sildenafil or tadalafil. In a placebo-controlled study in 24 subjects 4578 years of age receiving Urorec, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests (standing versus su |
