Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
 Urorec 8 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
 Each hard capsule contains 8 mg silodosin.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
 Hard capsule.
White, opaque, hard gelatin capsule, size 0.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
 Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
4.2 Posology and method of administration
 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).
Elderly patients
No dose adjustment is required in the elderly (see section 5.2).
Renal impairment
No dose adjustment is required for patients with mild renal impairment (CLCR50 to 80 ml/min).
A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR30 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).
Hepatic impairment
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).
Children and adolescents
There is no relevant indication for use of Urorec in children and adolescents.
Method of administration
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.
4.3 Contraindications
 Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
 Intraoperative Floppy Iris Syndrome (IFIS)
IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1blockers or previously treated with α1blockers. This may lead to increased procedural complications during the operation.
The initiation of therapy with Urorec is not recommended in patients for whom cataract surgery is scheduled. Discontinuing treatment with an α1blocker 12 weeks prior to cataract surge