XATRAL XL

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

ALFUZOSIN HYDROCHLORIDE

متاح من:

AVENTIS PHARMA - Indonesia

INN (الاسم الدولي):

ALFUZOSIN HYDROCHLORIDE

جرعة:

10.00 MG

الشكل الصيدلاني:

TABLET PELEPASAN LAMBAT

الوحدات في الحزمة:

DUS, 1 BLISTER @ 30 TABLET PELEPASAN LAMBAT

المصنعة من قبل:

SANOFI WINTHROP INDUSTRIE - France

تاريخ الترخيص:

2020-08-13

خصائص المنتج

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Alfuzosi n HCI
Prolonged-release tablet
SANOFI-,
COMPOSITION
Each Xatral XL 10 mg tablet contains, 10 mgAlfuzosin hydrochloride
PHARMACEUTICAL FORM
Prolonged release tablet
CLINICAL DATA
Therapeutic Indications
Treatment
of
the
functional
symptoms
of
benign
prostatic
hypertrophy. Adjuvant treatment to a catheter in acute urinary
retention related to benign prostatic hypertrophy.
Dosage and method of administration
Oral Use.
The tablet must be swallowed whole with a glass of water (see
special warnings and special precautions for use).
The recommended dosage is one 10 mg tablet per day, to be taken
immediately after the evening meal.
Adjuvant treatment
to
a
catheter
in acute
urinary
retention
related to benign prostatic hypertrophy:
The recommended dosage is one 10 mg tablet per day, to be taken
after a meal, from the first day of catheterisation onwards.
The treatment is administered for 3 to 4 days, i.e. 2 to 3 days while
the catheter is in place and 1 day after it is removed.
Contra-indications
This
medicinal
must
not
be
administered
in
the
following
situations:
-
hypersensitivity
to
alfuzosin
and/or
any
of
the
other
components;
postural hypotension;
-
liver failure;
severe kidney failure (creatinine clearance< 30 ml/min),
intestinal obstruction, as this medicine contains castor oil.
Special warnings and precautions for use
_SPECIAL WARNINGS _
As
with all alpha-1 blockers, some patients, and in particular
those treated
with antihypertensives, may experience postural
hypotension within a few hours following administration, possibly
with symptoms (dizzy sensations, fatigue, sweating).
If
this
occurs,
patients
should
remain lying
down
until
the
symptoms have completely subsided.
These effects are usually transient, occur at the beginning of
treatment and do not generally prevent continued treatment.
Patients should be warned of the possible occurrence of these
events.
Caution is recommended, particularly in the elderly.
_lntraoperative Floppy Iris Syndrome _
(IFIS, a small pupil syndrome
varian