Urorec

Company: Recordati Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Silodosin 4mg, 8mg.
Description: Resp. yellow or white, opaque, hard gelatin capsules.
Presentation: 4mg-30, €19.80; 8mg-30, €19.80.
Indication: Treatment of the symptoms of benign prostatic hyperplasia (BPH).

Pharmacology: Silodosin is highly selective for α_1A‑adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these α_1A‑adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility. This causes an improvement of the lower urinary tract symptoms associated with BPH.
Dosage: Take with food, must be swallowed whole with water at the same time each day. Adult: 8mg once daily. Moderate renal impairment: Initially, 4mg once daily; may be increased to 8mg once daily after one week depending on the patient’s response. Elderly: As per adults. Children: Not applicable.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special precautions: Perform digital rectal examination and determine prostate specific antigen levels before treatment and at regular intervals afterwards to exclude prostate cancer. Not recommended: Severe renal/hepatic impairment, orthostatic hypotension. Syncope may occur. Cataract surgery (do not initiate therapy if surgery scheduled). Reduces male fertility temporarily. Driving/using machines. Contains mannitol.
Drug interactions: Not recommended: Other α-adrenoreceptor blockers, potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir). Caution: Antihypertensives. Inhibitors/ inducers of CYP3A4, alcohol dehydrogenase and UGT2B7, PDE‑5 inhibitors.
Adverse drug reactions: Dizziness, orthostatic hypotension, nasal congestion, diarrhoea, retrograde ejaculation, anejaculation.
Full prescribing information and references available from Recordati Ireland Ltd. Telephone: 1800 303351. E-mail: medinfo@recordati.co.uk