UROREC silodosin 4 mg hard capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

silodosin, Quantity: 4 mg

Available from:

Mayne Pharma International Pty Ltd

INN (International Name):

silodosin

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: mannitol; sodium lauryl sulfate; magnesium stearate; Gelatin; titanium dioxide; iron oxide yellow; pregelatinised maize starch

Administration route:

Oral

Units in package:

10 (starter pack), 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men

Product summary:

Visual Identification: An opaque yellow/opaque yellow size 3 hard gelatine capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-23

Patient Information leaflet

UROREC
®
1
UROREC
®
_silodosin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about UROREC. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking UROREC
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT UROREC IS USED
FOR
UROREC IS FOR USE BY MEN ONLY.
UROREC is used for the relief of
lower urinary tract symptoms
associated with a medical condition
called benign prostatic hyperplasia or
BPH. BPH is a condition where the
prostate gland (which is near your
bladder) has become bigger making
it more difficult for you to pass urine.
This can lead to symptoms such as:
•
weak or interrupted stream of
urine
•
feeling that you cannot empty
your bladder completely
•
delay before you start to pass
urine
•
needing to pass urine often,
especially at night
•
feeling that you must pass urine
straight away.
BPH occurs only in men and is
common over the age of 50 years. In
some men, BPH can lead to serious
problems, including urinary tract
infections and the sudden inability to
pass urine at all.
This medicine contains the active
ingredient silodosin. Silodosin
belongs to a group of medicines
called alpha-blockers.
UROREC works by helping relax the
smooth muscles in the prostate, in
that way it improves flow of urine.
This makes it easier for you to pass
water and relieves your symptoms.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
UROREC is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
UROREC
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE UROREC IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing silodosin
•
a

Summary of Product characteristics

v 4.0
1
AUSTRALIAN PRODUCT INFORMATION
UROREC
®
(SILODOSIN) CAPSULES
1.
NAME OF THE MEDICINE
Silodosin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
UROREC hard gelatin capsules contain either 4 mg or 8 mg of silodosin.
3.
PHARMACEUTICAL FORM
UROREC 4 mg is presented as yellow, opaque, hard gelatin capsules.
UROREC 8 mg is presented as white, opaque, hard gelatin capsules.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
UROREC is indicated for the relief of lower urinary tract symptoms
(LUTS) associated with
benign prostatic hyperplasia (BPH) in adult men.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose is one capsule of UROREC 8 mg daily.
METHOD OF ADMINISTRATION
A capsule should be taken with food, preferably at the same time every
day. It should not be
broken or chewed but swallowed whole, preferably with a glass of
water.
DOSAGE ADJUSTMENT
Use in the Elderly
No dose adjustment is required in the elderly.
Use in Renal Impairment
No dose adjustment is required for patients with mild renal impairment
(CL
CR
≥ 60 to
≤ 89 ml/min; eGFR ≥ 60 to ≤ 89 ml/min/1.73 m
2
; CKD stage G2).
A starting dose of 4 mg once daily is recommended in patients with
moderate renal
impairment (CL
CR
≥ 30 to ≤ 59 ml/min; eGFR ≥ 30 to ≤ 59 ml/min/1.73 m
2
; CKD stage G3a
and G3b). After a minimum of one week a dose increase may be
considered. The dose can be
v 4.0
2
carefully increased to 8 mg once daily depending on the individual
patient’s response (see
_section 4.4 Special Warnings and Precautions for Use_
and
_section 5.2. Pharmacokinetic _
_Properties – Use in Renal Impairment_
).
The use in patients with severe renal impairment (CL
CR
< 30 ml/min; eGFR < 30
ml/min/1.73m
2
; CKD stage G4 and G5) is not recommended (see
_section 4.4. Special _
_Warnings and Precautions for Use_
).
Use in 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
_