Urorec

Posology The recommended dose is one capsule of Urorec 8 mg daily. For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below). 2). Renal impairment No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).

A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR ≥ 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient’s response.

2). Hepatic impairment No dose adjustment is required for patients with mild to moderate hepatic impairment. 2). 3 Paediatric population There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).

Method of administration Oral use. The capsule should be taken with food, preferably at the same time every day. The capsule should not be broken or chewed but swallowed whole, preferably with a glass of water.

Summary of the safety profile The safety of silodosin has been evaluated in four Phase II-III 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. 4). Tabulated list of adverse reactions In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience 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 (cannot be estimated from available data).

Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness. System organ class Very common Common Uncommon Rare Very rare Not known Immune system disorders Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1 Psychiatric disorders Libido decreased Nervous system disorders Dizziness Syncope Loss of consciousness1 Cardiac disorders Tachycardia1 Palpitations1 Vascular disorders Orthostatic hypotension Hypotension1 Respiratory, thoracic and mediastinal disorders Nasal congestion Gastrointestinal disorders Diarrhoea Nausea Dry mouth Hepatobiliary disorders Abnormal liver function tests1 6 System organ class Very common Common Uncommon Rare Very rare Not known Skin and subcutaneous tissue disorders Skin rash1, Pruritus1 Urticaria1 Drug eruption1 Reproductive system and breast disorders Ejaculatory disorders, including retrograde ejaculation, anejaculation Erectile dysfunction Injury, poisoning and procedural complication Intraoperative Floppy Iris Syndrome 1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in Phase I-IV clinical trials and non-interventional studies).

Intraoperative Floppy Iris Syndrome (IFIS) IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1-blockers or previously treated with α1-blockers. This may lead to increased procedural complications during the operation.

The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled. Discontinuing treatment with an α1-blocker 1-2 weeks prior to cataract surgery 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 silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.

Orthostatic effects The incidence of orthostatic effects with silodosin 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 silodosin is not recommended. 2). 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 silodosin, 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 silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.

8). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. 4

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