AVODART SOFT GELATIN CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

DUTASTERIDE

Unit dalam pakej:

30Capsule Capsules; 90Capsule Capsules

Dikeluarkan oleh:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
AVODART SOFT GELATIN CAPSULES
_ _
_ _
Dutasteride (0.5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What AVODART is used for
2.
How AVODART works
3.
Before you use AVODART
4.
How to use AVODART
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
AVODART
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT AVODART IS USED FOR
Avodart is used to treat men
with an enlarged prostate
(
_benign prostatic hyperplasia_
)
-
a non-cancerous growth of the
prostate gland caused by
producing too much of a
hormone called DHT
(
_dihydrotestosterone_
).
HOW AVODART WORKS
The active ingredient is
dutasteride. It belongs to a group
of medicines called 5-alpha
reductase inhibitors.
As the prostate grows, it can
lead to urinary problems, such
as difficulty in passing urine and
a need to go to the toilet more
frequently. It can also cause the
flow of the urine to be slower
and less forceful. If left
untreated, there is a risk that
your urine flow will be
completely blocked.
Avodart helps to shrink the
prostate and relieve symptoms,
by reducing the amount of DHT
your body produces.
BEFORE YOU USE AVODART
-
_When you must not use it _
•
if you are allergic
(hypersensitive) to dutasteride
or to any of the other
ingredients of Avodart, or to
other similar medicines
known as 5-alpha reductase
inhibitors.
•
if you are female, children and
adolescents. This medicine is
for adult men only.
•
if you have severe liver
impairment
If any of these apply to you, do
not take Avodart until you have
checked with your doctor.
Women who are pregnant (or
may be) must not handle leaking
capsules. Dutasteride is
absorbed through the skin and
can affect the normal
development of a male baby.
Contact your doctor for advice if
a pregnant woman has come into
contact with the contents of
Avodart capsule.
-
_Before you start to use it _
If you have liver disease, check
with your doctor that Avodart is
suitable for you. You may need
extra check-u

Ciri produk

[GSK logo]
AVODART
DUTASTERIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule for oral use contains 0.5 mg dutasteride (_see List of
Excipients_).
PHARMACEUTICAL FORM
Capsules: dull yellow in colour, opaque, oblong soft gelatin capsules
marked with GX CE2.
CLINICAL PARTICULARS
INDICATIONS
MONOTHERAPY
_AVODART_ is indicated for the treatment and control of symptomatic
benign prostatic hyperplasia (BPH) in
men with an enlarged prostate to improve symptoms, reduce the risk of
acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
COMBINATION WITH ALPHA-BLOCKER
_AVODART_ in combination with the alpha-blocker tamsulosin is
indicated for the treatment of symptomatic
BPH in men with an enlarged prostate.
For
information
on
effects
of
treatment
and
patient
populations
studied
in
clinical
trials,
see
5.1
Pharmacodynamic Properties.
DOSAGE AND ADMINISTRATION
ADULT MALES (INCLUDING ELDERLY)
Capsules should be swallowed whole and not chewed or opened, as
contact with the capsule contents
may result in irritation of the oropharyngeal mucosa.
_AVODART_ may be taken with or without food.
The recommended dose of _AVODART_ is one capsule (0.5 mg) taken orally
once a day
Although an improvement may be observed at an early stage, treatment
for at least 6 months may be
necessary in order to assess objectively whether a satisfactory
response to the treatment can be achieved.
For the treatment of BPH, _AVODART_ can be administered alone or in
combination with the alpha-blocker
tamsulosin (0.4mg).
RENAL IMPAIRMENT
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied. However, no
adjustment in dosage is anticipated for patients with renal impairment
(_see Pharmacokinetisc_)
HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied so caution should
be used in patients with mild to moderate hepatic impairment (_see
Special Warnings and Precautions for _
_Use and Pharmacokinetics_). In patients with severe hepatic
impairment, th