DUODART 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dutasteride, Quantity: 500 microgram; tamsulosin hydrochloride, Quantity: 400 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Dutasteride,Tamsulosin hydrochloride

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: maize starch; carrageenan; Gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow FCF; Carnauba Wax; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide

Administration route:

Oral

Units in package:

90 capsule (200 mL bottle), 30 capsule (100 mL bottle), 7 capsule (40 mL bottle)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Duodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH).

Product summary:

Visual Identification: Oblong, hard-shell capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-10-28

Patient Information leaflet

DUODART
®
_500 MICROGRAMS /400 MICROGRAMS_
_Dutasteride 500 micrograms and tamsulosin HCl 400 micrograms_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take DUODART.
This leaflet answers some common
questions about DUODART. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
DUODART against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS DUODART
USED FOR?
DUODART is a combination of two
medicine; dutasteride and tamsulosin
hydrochloride. Dutasteride belongs to
a group of medicines called 5-alpha
reductase enzyme inhibitors and
tamsulosin hydrochloride belongs to
a group of medicines called alpha-
blockers. These medicines can be
used either alone or in combination
in men who have a condition known
as benign prostatic hyperplasia
(BPH).
BPH is a non-cancerous enlargement
of the prostate gland which is located
at the lower portion of the urinary
bladder surrounding the urethra
(urine carrying tube). In men with
BPH, the prostate gland becomes
large enough to squeeze the urine
tube running through it. If the urine
tube is squeezed it narrows, making
it more difficult for you to pass urine
normally and you may have some or
all of the following symptoms:
•
difficulty in starting to urinate
•
an interrupted, weak urinary
stream
•
more frequent urination,
especially at night
•
feeling that you need to urinate
right away
•
leaking or dribbling
•
a feeling that you cannot empty
your bladder completely.
As the disease progresses, untreated
BPH can lead to an increased risk of
complete blockage of urine flow
(acute urinary retention) and/or the
need for surgery.
Prostate growth is caused by a
hormone in the blood called
dihydrotestosteron

Summary of Product characteristics

1
AUSTRALIAN PI – DUODART (DUTASTERIDE/TAMSULOSIN
HYDROCHLORIDE) CAPSULE
1
NAME OF THE MEDICINE
Dutasteride/tamsulosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dutasteride 500 µg and 400 µg tamsulosin
hydrochloride.
_Dutasteride_ - Dutasteride is a white to pale yellow powder. It is
practically insoluble in water,
and
soluble
in
organic
solvents,
dimethyl
sulfoxide,
acetone,
methanol,
ethanol
and
ispropanol.
_Tamsulosin Hydrochloride -_ White or almost white crystalline powder.
It is sparingly soluble in
water, and slightly soluble in the following solvents; Acetone,
Ethanol, Ethyl acetate and
Methanol.
The pKa values for tamsulosin are as follows: pKa1 = 8.4 (secondary
amine) and pKa2 = 10.7
(sulphonamide). The partition coefficient is clogP = 2.2 (calculated
using Property Calculator
4.7)
EXCIPIENTS WITH KNOWN EFFECT
Lecithin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DUODART capsules (dutasteride 500 µg/tamsulosin hydrochloride 400
µg): oblong, hard-
shell capsules with a brown body and an orange cap imprinted with GS
7CZ in black ink
[each containing one oblong, opaque, dull-yellow dutasteride soft
gelatin capsule (500 µg
dutasteride) and white to off-white tamsulosin hydrochloride pellets
(400 µg tamsulosin
hydrochloride)].
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DUODART is indicated for the management of moderate to severe
symptomatic benign
prostatic hyperplasia (BPH).
4.2
DOSE AND METHOD OF ADMINISTRATION
DUODART must be taken approximately 30 minutes after the same meal
each day. Patients
should be advised that DUODART should not be taken on an empty stomach
as this may
increase
the
potential
for
cardiovascular
related
adverse
events
such
as
orthostatic
hypotension.
2
For advice on switching from tamsulosin monotherapy to DUODART
combination therapy,
please read the information under Section 5.1 PHARMACODYNAMIC
PROPERTIES.
POPULATIONS
ADULT MALES (INCLUDING ELDERLY)
The recommended dose of DUODART is