DUTABIT 0.5 (DUTASTERIDE SOFT CAPSULES 0.5MG)

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

DUTASTERIDE

Dostupné z:

SYNERRV SDN BHD

INN (Medzinárodný Name):

DUTASTERIDE

Počet v balení:

30 Capsules

Výrobca:

Aurobindo Pharma Limited (Unit VII)

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
DUTABIT 0.5 (DUTASTERIDE SOFT
CAPSULE 0.5MG)
DUTASTERIDE (0.5MG)
WHAT IS IN THIS LEAFLET
1.
What DUTABIT is used for
2.
How DUTABIT works
3.
Before you use DUTABIT
4.
How to use DUTABIT
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
DUTABIT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DUTABIT IS USED FOR
DUTABIT 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 DUTABIT 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.
DUTABIT helps to shrink the
prostate and relieve symptoms,
by reducing the amount of DHT
your body produces.
BEFORE YOU USE DUTABIT
-
_When you must not use it _
if you are allergic
(hypersensitive) to
dutasteride or to any of the
other ingredients of
DUTABIT, 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 DUTABIT 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
DUTABIT capsule.
-
_Before you start to use it _
If you have liver disease, check
with your doctor that
DUTABIT is suitable for you.
You may need extra check-ups
while you are t

Súhrn charakteristických

NAME OF THE MEDICINAL PRODUCT: Dutasteride Soft Capsules 0.5 mg
(TRADE) NAME OF PRODUCT: DUTABIT 0.5
STRENGTH : 0.5 mg.
PHARMACEUTICAL DOSAGE FORM: Soft Capsules.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dutasteride Soft Capsules 0.5 mg: Each Capsule contains Dutasteride
Ph. Eur. 0.5 mg.
PHARMACEUTICAL FORM:
Dull yellow, opaque, oblong shaped, size ‘6’ soft gelatin capsule
containing clear
colorless to pale yellow viscous oil.
CLINICAL PARTICULARS
Therapeutic indications
_Monotherapy:_ Dutasteride 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:_ Dutasteride in combination with the
alpha-blocker
tamsulosin is indicated for the treatment of symptomatic BPH in men
with an enlarged
prostate.
POSOLOGY AND METHOD OF ADMINISTRATION
Adult Males (Including Elderly): Recommended Dose: 1 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.
Treatment of BPH: Dutasteride can be administered alone or in
combination with the
α-blocker, tamsulosin (0.4 mg).
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.
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. In patients with severe hepatic impairment, the
use of dutasteride
is contraindicated..
Administration: Capsules should be swallowed whole and not chewed or
opened, as
contact with the capsule contents may result in irritation of the
oropharyngeal mucosa.
Dutasteride may be taken with o