Silodosin Rontis Capsules Hard 4mg

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

SILODOSIN

Saatavilla:

Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece

ATC-koodi:

G04CA04

INN (Kansainvälinen yleisnimi):

SILODOSIN 4 mg

Lääkemuoto:

HARD CAPSULE

Koostumus:

SILODOSIN 4 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

UROLOGICALS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2019-02-19

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILODOSIN RONTIS 4 MG HARD CAPSULES
SILODOSIN RONTIS 8 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 Rontis is and what it is used for
2.
What you need to know before you take Silodosin Rontis
3.
How to take Silodosin Rontis
4.
Possible side effects
5.
How to store Silodosin Rontis
6.
Contents of the pack and other information
1.
WHAT SILODOSIN RONTIS IS AND WHAT IT IS USED FOR
WHAT SILODOSIN RONTIS IS
Silodosin Rontis belongs to a group of medicines called alpha
1A
-adrenoreceptor blockers.
Silodosin Rontis 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 RONTIS IS USED FOR
Silodosin Rontis 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 RONTIS
DO NOT TAKE
SILODOSIN RONTIS
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 Rontis
•
If you are undergoing eye surgery because of cloudiness of the lens (

Valmisteyhteenveto

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Silodosin Rontis 4 mg hard capsules
Silodosin Rontis 8 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Silodosin Rontis 4 mg hard capsules
Each hard capsule contains 4 mg silodosin.
Silodosin Rontis 8 mg hard capsules
Each hard capsule contains 8 mg silodosin.
Excipients with known effect:
Each 4 mg hard capsule contains 0.12 mg sodium.
Each 8 mg hard capsule contains 0.24 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Silodosin Rontis 4 mg hard capsules
Yellow, opaque, hard gelatin capsule, size 3, printed with black ink
“4” on the cap.
Silodosin Rontis 8 mg hard capsules
White, opaque, hard gelatin capsule, size 0, printed with black ink
“8” on the cap.
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 Rontis 8 mg daily.
For special patient populations, one
capsule of Silodosin Rontis 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).
Page 2 of 9
_Hepatic impairment_
No dose adjustment is required for patients with mild to moderate
hepatic impairment.
As no data are available, therefore, 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 Silodosin