YENTREVE 20 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DULOXETINE AS HYDROCHLORIDE

متاح من:

ELI LILLY ISRAEL LTD, ISRAEL

ATC رمز:

N06AX21

الشكل الصيدلاني:

CAPSULES

تركيب:

DULOXETINE AS HYDROCHLORIDE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

LILLY S.A., SPAIN

المجال العلاجي:

DULOXETINE

الخصائص العلاجية:

Yentreve is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).

تاريخ الترخيص:

2020-03-31

نشرة المعلومات

I YENTCP A 12
Page 1 of 8
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) -
1986
This medicine is dispensed with a physician’s prescription only
YENTREVE
20 MG
Capsules
YENTREVE
40 MG
Capsules
ACTIVE INGREDIENT:
Duloxetine 20 mg
ACTIVE INGREDIENT:
Duloxetine 40 mg
INACTIVE INGREDIENTS AND ALLERGENS: See section 6 “_Additional
information_” and section 2
“_Important information about some of this medicine's
ingredients”._
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
please contact your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if their signs of illness are the same as
yours.
This medicine is intended for women above the age of 18.
Even though YENTREVE is not indicated to treat depression, the active
ingredient in this
preparation (duloxetine) is used as an antidepressant.
Antidepressants and antianxiety medicines increase the risk of
suicidal behavior and thoughts
among children, adolescents and young adults up to 25 years of age.
When beginning treatment with this medicine, patients of all ages and
their relatives, must
monitor behavioral changes such as worsening of depression, suicidal
thoughts,
aggressiveness etc.
If changes such as these occur, contact the doctor immediately.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Yentreve is intended to treat moderate to severe Stress Urinary
Incontinence (SUI) in women.
THERAPEUTIC GROUP:
Serotonin and norepinephrine reuptake inhibitors (SNRIs).
Stress urinary incontinence is a medical condition in which patients
have accidental loss or
leakage of urine during physical exertion or activities such as
laughing, coughing, sneezing,
lifting, or exercise.
Yentreve is believed to work by increasing the strength of the muscle
that holds back urine
when you laugh, sneeze, or perform physical activities.
The efficacy of Ye

خصائص المنتج

X YENTCP A 13
Page
1
of
17
1.
NAME OF THE MEDICINAL PRODUCT
YENTREVE
20 mg hard gastro-resistant capsules
YENTREVE
40 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg or 40 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each 20mg capsule contains 12 mg sucrose and 27 mg sugar spheres.
Each 40mg capsule contains 24.2 mg sucrose and 54 mg sugar spheres.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsules.
YENTREVE 20 mg
Opaque blue body, imprinted with ‘20 mg’ and an opaque blue cap,
imprinted with ‘9544’.
YENTREVE 40 mg
Opaque orange body, imprinted with ’40 mg’ and an opaque blue cap,
imprinted with ‘9545’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Although Yentreve is not indicated for the treatment of depression,
it’s active
ingredient (duloxetine) also exists in antidepressant medicinal
products.
Antidepressants increased the risk of suicidal thoughts and behavior
in
children, adolescents, and young adults in short-term studies. These
studies did
not show an increase in the risk of suicidal thoughts and behavior
with
antidepressant use in patients over age 25; there was a reduction in
risk with
antidepressant use in patients aged 65 and older [see Warnings and
Precautions
(4.4)].
In patients of all ages who are started on duloxetine or other
antidepressant
therapy monitor closely for clinical worsening and emergence of
suicidal
thoughts and behaviors. Advise families and caregivers of the need for
close
observation and communication with the prescriber [see Warnings and
Precautions (4.4)].
X YENTCP A 13
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of
17
YENTREVE is indicated for women for the treatment of moderate to
severe Stress Urinary
Incontinence (SUI).
YENTREVE is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Swallow YENTREVE whole. Do not chew or crush. Do not open the capsu