inTASTERIDE (Dutasteride) 0.5mg Soft Gelatin Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

Intega Sdn. Bhd.

INN (Nama Antarabangsa):

DUTASTERIDE

Unit dalam pakej:

2 x 15 Capsules; 6 x 15 Capsules

Dikeluarkan oleh:

Laboratorios Leon Farma S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INTASTERIDE SOFT GELATIN CAPSULES
_Dutasteride 0.5mg_
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1
WHAT IS IN THIS LEAFLET
1.
What inTASTERIDE is
used for
2.
How inTASTERIDE
works
3.
Before you use
inTASTERIDE
4.
How to use
inTASTERIDE
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
inTASTERIDE
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT INTASTERIDE IS USED FOR
inTASTERIDE 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 INTASTERIDE 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
the 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.
InTASTERIDE helps to shrink
the prostate and relieve
symptoms, by reducing the
amount of DHT your body
produces.
BEFORE YOU USE INTASTERIDE
_ _
_When you must not use it _
You must not use inTASTERIDE
if you:
•
are allergic to dutasteride or
any of the other ingredients
of inTASTERIDE, or to
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 inTASTERIDE 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
inTASTERIDE.
_ _
_Before you start to use it _
If

Ciri produk

LEÓN CODE
FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
10 mm
10 mm
490 mm
510 mm
10 mm
202 mm
222 mm
10 mm
340 mm
170 mm
148 mm
LAETUS CENTERED WITHIN FINAL FOLDED LAETUS CENTERED WITHIN FINAL
FOLDED
37 mm
37 mm
BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
10 mm
10 mm
490 mm
510 mm
10 mm
202 mm
222 mm
10 mm
ONLY FOR POSITION
ONLY FOR POSITION
1. NAME OF THE MEDICINAL PRODUCT
inTASTERIDE (Dutasteride) 0.5 mg soft gelatin capsules
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each capsule contains 0.5 mg dutasteride. For the full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft capsule
Dutasteride 0.5 mg soft capsules are oblong soft gelatin
capsules (approximately 16.5 x 6.5 mm) of light yellow colour,
filled with transparent liquid.
4. CLINICAL PARTICULARS
▪
4.1 Therapeutic indications
Monotherapy
inTASTERIDE 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
inTASTERIDE in combination with the alpha-blocker tamslosin is
indicated for the treatment of symptomatic BPH in men with an
enlarged prostate.
▪
4.2 Posology and method of 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.
inTASTERIDE may be taken with or without food.
The recommended dose of inTASTERIDE 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, inTASTERIDE can be administered alone or in combination
with the alpha-blocker tamsulosin (0.4mg).
_Renal impairment_
The effect of renal impairment on dutasteride pharm