Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
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).
No dose adjustment is required in the elderly (see section 5.2).
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. The use in patients with severe renal impairment (CLCR <30 ml/min) is not recommended (see sections 4.4 and 5.2).
No dose adjustment is required for patients with mild to moderate hepatic impairment.
As no data are available, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
There is no relevant use of Urorec in the paediatric population in the indication.
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.
Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse reaction was postural hypotension. If ingestion is recent, induction of vomiting or gastric lavage may be considered. Should overdose of silodosin lead to hypotension, cardiovascular support has to be provided. Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) protein bound.
Shelf life: 3 years.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.
Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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