Urief Film-Coated Tablets 4mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Silodosin

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

Silodosin

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

KISSEI PHARM CO LTD

Risalah maklumat

URIEF
® FILM COATED TABLETS
Silodosin (4mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Urief is used for
2.
How Urief works
3.
Before you use Urief
4.
How to use Urief
5.
While you are using Urief
6.
Side effects
7.
Storage and Disposal of Urief
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT URIEF
IS USED FOR
Urief is used to treat the symptoms of
benign prostatic hyperplasia (BPH, an
enlarged prostate gland) in patients ≥50
years. The prostate gland is an organ
found at the base of the bladder in men.
When enlarged, it can cause problems
with the flow of urine.
HOW URIEF WORKS
The active substance in Urief, silodosin,
is an alpha-adrenoceptor antagonist. It
works by blocking receptors called
alpha1A adrenoreceptors in the prostate
gland, the bladder and the urethra (the
tube that leads from the bladder to the
outside of the body). When these
receptors are activated, they cause the
muscles controlling the flow of urine to
contract. By blocking these receptors,
silodosin allows these muscles to relax,
making it easier to pass urine and
relieving the symptoms of BPH.
BEFORE YOU USE URIEF
-
_When you must not use it _
- If you are allergic (hypersensitive)
to silodosin or any ingredients of
Urief.
- If you have low blood pressure
- If you have liver function problems
- If you have kidney failure
_Children and adolescents _
Urief is not for use in children and
adolescents as it has not been studied
in patients under 18 years. Ask your
doctor or pharmacist for advice before
taking Urief.
_ _
-
_Before you start use it _
Before taking Urief, tell your doctor
or pharmacist if you are allergic to it;
or if you have any other allergies.
This product may contain inactive
ingredients, which can cause allergic
reactions or other problems. Talk to
your pharmacist for more details.
Before using this medication, tell
your doctor or pharmacist your
medical history, especially of:
- Low blood pressure
- Liver function

Ciri produk

(Silodosin)
Film-Coated Tablets 4 mg
1. PRODUCT NAME
Urief
®
Film-Coated Tablets 4mg
2. PRODUCT DESCRIPTION
3. INDICATION
Bladder outlet obstruction associated with benign prostatic
hyperplasia in
patients
≥
50 years.

URIEF Tablet is associated with a high incidence of adverse reactions
and abnormal
ejaculation is reported frequently as a characteristic adverse
reaction. URIEF
Tablet should be used after careful consideration is given to the
risks associated
with its use and carefully explaining the adverse reactions to the
patient. (See
“6.2 Important Precautions” and “9. Adverse Reactions”.)
4. DOSAGE AND ADMINISTRATION
The adult dosage for oral use is 4 mg of silodosin twice daily after
breakfast and
evening meal. The dosage may be reduced according to the patient’s
conditions.

The plasma concentration of silodosin may be elevated in patients with
impaired
hepatic function. It has been reported that plasma concentration of
silodosin is
increased in patients with impaired renal function. Therefore,
starting treatment
at a low dose (2 mg/dose) while observing the condition of the
patient, for
instance, should be considered. (See “11.2 PHARMACOKINETICS”.)
5. CONTRAINDICATIONS
Hypersensitivity to any of the components of Urief
®
Tablets.
6. WARNINGS AND PRECAUTIONS
6.1 CAREFUL ADMINISTRATION (URIEF
® TABLETS SHOULD BE ADMINISTERED WITH
CARE IN THE FOLLOWING PATIENTS)
(1) Patients with orthostatic hypotension. [The symptoms may be
aggravated.]
(2) Patients with impaired hepatic function.[Elevated plasma drug
concentrations may occur. (See .)]
(3) Patients with impaired renal function. [Elevated plasma drug
concen
trations have been reported. (See .)]
(4) Patients treated with phosphodiesterase-5 inhibitors. (See “7.
INTER-
ACTION WITH OTHER MEDICAMENTS”.)
6.2 IMPORTANT PRECAUTIONS
(1) Abnormal ejaculation (e.g. retrograde ejaculation) has been
reported.
Therefore, Urief
®
Tablets should be used after obtaining the under-
standing of patie