Yentreve
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-12-2021
Charakterystyka produktu
(SPC)
21-12-2021
Sprawozdanie z oceny publicznego
(PAR)
18-07-2008
Składnik aktywny:
duloxetine hydrochloride
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
N06AX21
INN (International Nazwa):
duloxetine
Grupa terapeutyczna:
Psychoanaleptics,
Dziedzina terapeutyczna:
Urinary Incontinence, Stress
Wskazania:
Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Podsumowanie produktu:
Revision: 28
Status autoryzacji:
Authorised
Data autoryzacji:
2004-08-11
Ulotka dla pacjenta
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
YENTREVE 40 MG HARD GASTRO-RESISTANT CAPSULES
YENTREVE 20 MG HARD GASTRO-RESISTANT CAPSULES
Duloxetine (as hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What YENTREVE is and what it is used for
2.
What you need to know before you take YENTREVE
3.
How to take YENTREVE
4.
Possible side effects
5.
How to store YENTREVE
6.
Contents of the pack and other information
1.
WHAT YENTREVE IS AND WHAT IT IS USED FOR
YENTREVE contains the active substance duloxetine. YENTREVE increases
the levels of serotonin
and noradrenaline in the nervous system.
YENTREVE is a medicine to be taken by mouth to treat Stress Urinary
Incontinence (SUI) in women.
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 YENTREVE is reinforced when combined with a training
program called Pelvic Floor
Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE YENTREVE
DO NOT TAKE YENTREVE IF YOU:
-
are allergic to duloxetine or any of the other ingredients of this
medicine (listed in section 6)
-
have liver disease
-
have severe kidney disease
-
are taking or have taken within the last 14 days, another medicine
known as a monoamine oxidase
inh
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
YENTREVE 20 mg
Each capsule contains 20 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule may contain up to 37 mg sucrose.
YENTREVE 40 mg
Each capsule contains 40 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule may contain up to 74 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
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
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
The recommended dose of YENTREVE is 40 mg twice daily without regard
to meals. After 2-4 weeks
of treatment, patients should be re-assessed in order to evaluate the
benefit and tolerability of the
therapy. Some patients may benefit from starting treatment at a dose
of 20 mg twice daily for two
weeks before increasing to the recommended dose of 40 mg twice daily.
Dose escalation may
decrease, though not eliminate, the risk of nausea and dizziness.
However, limited data are available to support the efficacy of
YENTREVE 20 mg twice daily.
3
The efficacy of YENTREVE has not been evaluated for longer than 3
months in placebo-controlled
studies. The benefit of treatment should be re-assessed at regular
intervals.
Combining YENTREVE with a pelvic floor muscle training (PFMT)
programme may be more
effective than either treatment alone. It is recommended that
consideration be given to concomitant
PFMT.
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