Silodosin Recordati

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, Alpha-adrenoreceptor antagonists

Therapeutic area:

Prostatic Hyperplasia

Therapeutic indications:

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

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-01-07

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILODOSIN RECORDATI 8 MG HARD CAPSULES
SILODOSIN RECORDATI 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 Silodosin Recordati is and what it is used for
2.
What you need to know before you take Silodosin Recordati
3.
How to take Silodosin Recordati
4.
Possible side effects
5.
How to store Silodosin Recordati
6.
Contents of the pack and other information
1.
WHAT SILODOSIN RECORDATI IS AND WHAT IT IS USED FOR
WHAT SILODOSIN RECORDATI IS
Silodosin Recordati belongs to a group of medicines called alpha
1A
-adrenoreceptor blockers.
Silodosin Recordati 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 SILODOSIN RECORDATI IS USED FOR
Silodosin Recordati 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 SILODOSIN RECORDATI
DO NOT TAKE SILODOSIN RECORDATI
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 Silodosin Recordati
•
I

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Silodosin Recordati 4 mg hard capsules
Silodosin Recordati 8 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Silodosin Recordati 4 mg hard capsules
Each hard capsule contains 4 mg silodosin.
Silodosin Recordati 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.
_ _
Silodosin Recordati 4 mg hard capsules
Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8
mm).
Silodosin Recordati 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 Silodosin Recordati 8 mg daily.
For special patient
populations, one capsule of Silodosin Recordati 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 Silodosin Recordati in the paediatric
population for the indication of benign
prostatic hyperplasia (BPH).
Method of administration
Oral use.
The