Urorec

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

silodosin

Available from:

Recordati Industria Chimica e Farmaceutica S.p.A. Via M Civitali 1-20148 Milan for Recordati Ireland Ltd.

INN (International Name):

silodosin

Dosage:

4mg

Pharmaceutical form:

capsules hard

Prescription type:

Prescription

Summary of Product characteristics

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