Urorec

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

silodosin

Available from:

Recordati Ireland Ltd

ATC code:

G04CA04

INN (International Name):

silodosin

Therapeutic group:

Urologicals

Therapeutic area:

Prostatic Hyperplasia

Therapeutic indications:

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2010-01-29

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UROREC 8 MG HARD CAPSULES
UROREC 4 MG HARD CAPSULES
Silodosin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Urorec is and what it is used for
2.
What you need to know before you take Urorec
3.
How to take Urorec
4.
Possible side effects
5.
How to store Urorec
6.
Contents of the pack and other information
1.
WHAT UROREC IS AND WHAT IT IS USED FOR
WHAT UROREC IS
Urorec belongs to a group of medicines called alpha
1A
-adrenoreceptor blockers.
Urorec is selective for the receptors located in the prostate, bladder
and urethra. By blocking these
receptors, it causes smooth muscle in these tissues to relax. This
makes it easier for you to pass water
and relieves your symptoms.
WHAT UROREC IS USED FOR
Urorec is used in adult men to treat the urinary symptoms associated
with benign enlargement of the
prostate (prostatic hyperplasia), such as:
•
difficulty in starting to pass water,
•
a feeling of not completely emptying the bladder,
•
a more frequent need to pass water, even at night.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE UROREC
DO NOT TAKE UROREC
if you are allergic to silodosin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING UROREC
•
If you are undergoing eye surgery because of cloudiness of the lens (
CATARACT SURGERY
), it is
important that you immediately inform your eye specialist that you are
using or have previously
26
u

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Urorec 4 mg hard capsules
Urorec 8 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Urorec 4 mg hard capsules
Each hard capsule contains 4 mg silodosin.
Urorec 8 mg hard capsules
Each hard capsule contains 8 mg silodosin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
_ _
Urorec 4 mg hard capsules
Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8
mm).
Urorec 8 mg hard capsules
White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6
mm).
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).
3
_Paediatric population _
There is no relevant use of Urorec in the paediatric population for
the indication of benign prostatic
hyperplasia (BPH).
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 ch