Duodart 0.5mg0.4mg Capsules

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

MAH:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN:

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

units_in_package:

30Capsule Capsules

manufactured_by:

Catalent Germany Schorndorf GmbH

PIL

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
DUODART CAPSULES
Dutasteride/ Tamsulosin hydrochloride (0.5 mg/0.4 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Duodart is used for
2.
How Duodart works
3.
Before you use Duodart
4.
How to use Duodart
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Duodart
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DUODART IS USED FOR
Duodart is used to treat men
with moderate to severe
symptoms of benign prostatic
hyperplasia (BPH) - a non-
cancerous growth of the
prostate gland caused by
producing too much of a
hormone called DHT
(
_dihydrotestosterone_
). Duodart
reduces the risk of acute
urinary retention and the need
for surgery in people with
moderate to severe symptoms
of BPH.
HOW DUODART WORKS
Duodart capsules are a
combination of two different
medicines called dutasteride
and tamsulosin. Dutasteride
belongs to a group of
medicines called 5-alpha
reductase inhibitors, and
tamsulosin belongs to a group
of medicines called alpha-
blockers.
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.
Dutasteride helps to shrink the
prostate and relieve symptoms,
by reducing the amount of
DHT your body produces.
Tamsulosin acts by relaxing
the muscles in your prostate
gland, making it easier to pass
urine, and improving your
symptoms.
BEFORE YOU USE DUODART
-
_When you must not use it _
Don’t take Duodart
•
if you are allergic
(
_hypersensitive_
) to
dutasteride, tamsulosin or
to any of the other
ingredients of Duodart, or
to other medicines known
as 5-alpha reductase
inhibitors.
•
if you are female or age
21 years and below. This
medicine is for adult men
only.
If any of these apply to you,
don’t take Duodart until you
have checked with your doctor.
Duodart must

SPC

1
PRESCRIBING INFORMATION
Duodart 0.5mg/0.4mg capsules
COMPOSITION
_Active principle: _Dutasteride / Tamsulosin hydrochloride.
_Excipients: _Antioxidant: E 321, colouring agent: E 110, excipients
for capsules.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE PRINCIPLE PER UNIT
Capsules: 0.5 mg dutasteride / 0.4 mg tamsulosin hydrochloride
(equivalent to
0.367mg tamsulosin).
Description: Oblong hard-shell capsules with a brown body and an
orange cap with
GS 7CZ printed on in black ink.
INDICATIONS/USES
Duodart is indicated as combination therapy for the treatment of
moderate to severe
symptoms of benign prostatic hyperplasia (BPH).
Duodart reduces the risk of acute urinary retention and the need for
surgery in
patients with moderate to severe symptoms of BPH.
DOSAGE/ADMINISTRATION
PATIENTS >21 YEARS OLD _(INCLUDING ELDERLY PATIENTS) _
_ _
The recommended dose of Duodart is one capsule daily (0.5 mg / 0.4
mg).
Duodart must always be taken with a glass of water, up to 30 minutes
after a meal.
It must never be taken on an empty stomach. Ideally it should be taken
at the same
time of the day (this means with the same meal).
The capsules should be swallowed whole and not chewed or opened, as
contact
with the capsule contents may result in irritation of the
oropharyngeal mucosa (see
“Warnings and Precautions”).
_SPECIAL DOSAGE INSTRUCTIONS _
_Elderly patients: _
No age-related dose adjustment is required.
2
_Renal impairment _
There is no experience available in patients with renal impairment.
Duodart should
therefore be used with caution especially in patients with severe
renal impairment
(creatinine clearance <10ml/ min) (see “Pharmacokinetics”).
_Hepatic impairment _
There is no experience available in patients with hepatic impairment.
Duodart should
be used with caution in patients with mild to moderate hepatic
impairment (see
“Warnings and
Precautions” and “Pharmacokinetics”). In patients with severe
hepatic impairment, the use of Duodart is contraindicated.
_Patients ≤21 years old: _
Duodart is not ind