Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
silodosin
Recordati Industria Chimica e Farmaceutica S.p.A. Via M Civitali 1-20148 Milan for Recordati Ireland Ltd.
silodosin
4mg
capsules hard
Prescription
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 4 mg silodosin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. _ _ Yellow, opaque, hard gelatin capsule, size 3. 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 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). _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 (CL CR ≥50 to ≤80 ml/min). A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CL CR ≥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 (CL CR <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). _Paediatric population _ There is no relevant use of Urorec in the paediatric population in the indication. 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 listed in section 6.1. 3 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 Izlasiet visu dokumentu