DUODART

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

G04CA02

الشكل الصيدلاني:

CAPSULES

تركيب:

DUTASTERIDE 0.5 MG; TAMSULOSIN HYDROCHLORIDE 0.4 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CATALENT GERMANY SCHORNDORF GMBH

المجموعة العلاجية:

TAMSULOSIN

المجال العلاجي:

TAMSULOSIN

الخصائص العلاجية:

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.

تاريخ الترخيص:

2016-05-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
DUODART
CAPSULES
EACH CAPSULE CONTAINS 0.5 MG DUTASTERIDE AND 0.4 MG TAMSULOSIN
HYDROCHLORIDE.
For a list of the inactive and allergenic ingredients in the
preparation, see section 2
“Important information about some ingredients of the medicine” and
section 6
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any other
questions, refer to the
physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
This medicine is intended for men only.
1. WHAT IS THE MEDICINE INTENDED FOR?
- Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
- Reduction in the risk of acute urinary retention (AUR) and surgery
in patients with
moderate to severe symptoms of BPH.
THERAPEUTIC GROUP: Duodart is 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.
DUODART 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 dihydrotestosterone.
Growth of the prostate can lead to urinary problems, such as
difficulty in passing urine
and a need to go to the toilet frequently. It can also cause the flow
of the urine to be
slower and less forceful. If left untreated, there is a risk that
urine flow will be
completely
blocked
(acute
urinary
retention)
.
This
requires
immediate
medical
treatment. Sometimes surgery is necessary to remove or reduce the size
of the
prostate gland.
Dutasteride lowers the production of a hormone called
dihydrotes

خصائص المنتج

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_Page 1 of 19 _
DUODART
1.
NAME OF THE MEDICINAL PRODUCT
DUODART
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin
hydrochloride, (equivalent to 0.367 mg
tamsulosin).
Excipients with known effect:
Each capsule contains lecithin (which may contain soya oil) and Sunset
Yellow (E 110). Each capsule
contains ≤ 0.1 mg sunset yellow.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Oblong, hard capsules with a brown body and an orange cap imprinted
with GS 7CZ in black ink.
Each hard capsule contains tamsulosin hydrochloride modified release
pellets and one dutasteride soft gelatin
capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in
patients with moderate to severe
symptoms of BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see section
5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults (including elderly) _
The recommended dose of Duodart is one capsule (0.5 mg/ 0.4 mg) once
daily.
Where appropriate, Duodart may be used to substitute concomitant
dutasteride and tamsulosin hydrochloride
in existing dual therapy to simplify treatment.
Where clinically appropriate, direct change from dutasteride or
tamsulosin hydrochloride monotherapy to
Duodart may be considered.
_ _
_ _
_Page 2 of 19 _
_ _
_Renal impairment _
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied. No
adjustment in dosage is anticipated for patients with renal impairment
(see section 4.4 and 5.2).
_Hepatic impairment _
The effect of hepatic impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied so caution
should be used in patients with mild to moderate hepatic impairment
(see section 4.4 and section 5.2). In
patients with severe hepatic impairment, the use of