Urorec capsules hard

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

silodosin

Dostupno od:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC koda:

G04CA04

INN (International ime):

silodosin

Doziranje:

4mg

Farmaceutski oblik:

capsules hard

Jedinice u paketu:

(30/3x10/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2018-11-07

Svojstava lijeka

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) in adult men.
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 _
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
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.
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Intraoperative Floppy Iris Syndrome (IFIS)
IFIS (a variant of small pupil syndrome) has been observed d