Silodosin Accord 8 mg hard capsules

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Silodosin

Inapatikana kutoka:

Accord Healthcare Ireland Ltd.

ATC kanuni:

G04CA04

INN (Jina la Kimataifa):

Silodosin

Kipimo:

8 milligram(s)

Dawa fomu:

Capsule, hard

Eneo la matibabu:

silodosin

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2020-06-26

Taarifa za kipeperushi

approved for print/date
PROOF ROUND
Technical
Approval
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
NON PRINTING COLOURS
COLOURS
1.
2.
3.
4.
5.
6.
1.
2.
3.
[e-mail]
G. Worth
07/05/2020
160x350
9pt
Evapharma
07/05/2020
05/06/2020
SILODOSIN 4 MG & 8 MG TABLETS PIL - IE
Black
BBBA8151
2
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
German GTIN 14
(incorporating PZN):
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILODOSIN ACCORD 4 MG
HARD CAPSULES
SILODOSIN ACCORD 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 Accord is and what it is used for
2. What you need to know before you take
Silodosin Accord
3. How to take Silodosin Accord
4. Possible side effects
5. How to store Silodosin Accord
6. Contents of the pack and other information
1. WHAT SILODOSIN ACCORD IS AND WHAT
IT IS USED FOR
WHAT SILODOSIN ACCORD IS
Silodosin Accord belongs to a group of medicines
called alpha
1A
-adrenoreceptor blockers.
Silodosin Accord 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 r

Tabia za bidhaa

Health Products Regulatory Authority
26 June 2020
CRN008XHZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Silodosin Accord 8 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 8 mg silodosin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Hard gelatin capsule of white body and cap (size 1) containing white
powder.
Each capsule is approximately 18.8 mm in length.
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 Accord 8mg daily. For
special patient populations, one capsule of Silodosin
Accord 4mg 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 Silodosin Accord 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 chewed
but swallowed whole, preferably with a glass of water.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active