DOUBLUTS dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

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

Pieejams no:

GlaxoSmithKline Australia Pty Ltd

Zāļu forma:

Capsule, modified release

Kompozīcija:

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

Ievadīšanas:

Oral

Vienības iepakojumā:

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

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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

Produktu pārskats:

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

Autorizācija statuss:

Registered

Autorizācija datums:

2020-03-04

Lietošanas instrukcija

DOUBLUTS
_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 DOUBLUTS.
This leaflet answers some common
questions about DOUBLUTS. 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
DOUBLUTS 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 DOUBLUTS
USED FOR?
DOUBLUTS 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
dihydrotestost

Produkta apraksts

1
AUSTRALIAN PI – DOUBLUTS (DUTASTERIDE/TAMSULOSIN
HYDROCHLORIDE) CAPSULE
1
NAME OF THE MEDICINE
Dutasteride/tamsulosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 micrograms of dutasteride and 400 micrograms
of 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
DOUBLUTS capsules (dutasteride 500 micrograms / tamsulosin
hydrochloride 400
micrograms): 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 (containing 500 micrograms of dutasteride) and white
to off-white tamsulosin
hydrochloride pellets (containing 400 micrograms of tamsulosin
hydrochloride)].
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DOUBLUTS is indicated for the management of moderate to severe
symptomatic benign
prostatic hyperplasia (BPH).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOUBLUTS must be taken approximately 30 minutes after the same meal
each day. Patients
should be advised that DOUBLUTS 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 DOUBLUTS
combination therapy,
please read the information under Section 5.1 PHARMACODYNAMIC
PROPERT