Duloxetine Lilly
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)
26-01-2015
Składnik aktywny:
duloxetine
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
N06AX21
INN (International Nazwa):
duloxetine
Grupa terapeutyczna:
Psychoanaleptics,
Dziedzina terapeutyczna:
Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major
Wskazania:
Duloxetine Lilly is indicated in adults for:Treatment of major depressive disorderTreatment of diabetic peripheral neuropathic painTreatment of generalised anxiety disorderDuloxetine Lilly is indicated in adults.
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Authorised
Data autoryzacji:
2014-12-08
Ulotka dla pacjenta
34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE LILLY
30 MG
HARD GASTRO-RESISTANT CAPSULES
DULOXETINE LILLY 60 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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Duloxetine Lilly is and what it is used for
2.
What you need to know before you take Duloxetine Lilly
3.
How to take Duloxetine Lilly
4.
Possible side effects
5.
How to store Duloxetine Lilly
6.
Contents of the pack and other information
1.
WHAT DULOXETINE LILLY IS AND WHAT IT IS USED FOR
Duloxetine Lilly contains the active substance duloxetine. Duloxetine
Lilly increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine Lilly is used in adults to treat:
•
depression
•
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
•
diabetic neuropathic pain (often described as burning, stabbing,
stinging, shooting or aching or
like an electric shock. There may be loss of feeling in the affected
area, or sensations such as
touch, heat, cold or pressure may cause pain)
Duloxetine Lilly starts to work in most people with depression or
anxiety within two weeks of starting
treatment, but it may take 2-4 weeks before you feel better. Tell your
doctor if you do not start to feel
better after this time. Your doctor may continue to give you
Duloxetine Lilly when you are feeling
better to prevent your depression or anxiety from returning
In people with diabetic neuropathic pain it can take some weeks befor
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Lilly 30 mg hard gastro-resistant capsules
Duloxetine Lilly 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duloxetine Lilly 30
mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule may contain up to 56 mg sucrose.
Duloxetine Lilly 60
mg
Each capsule contains 60 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule may contain up to 111 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Duloxetine Lilly 30
mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Duloxetine Lilly 60
mg
Opaque green body, imprinted with ‘60 mg’ and an opaque blue cap,
imprinted with ‘9542’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Lilly is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive disorder_
The starting and recommended maintenance dose is 60 mg once daily with
or without food. Dosages
above 60 mg once daily, up to a maximum dose of 120 mg per day have
been evaluated from a safety
perspective in clinical trials. However, there is no clinical evidence
suggesting that patients not
responding to the initial recommended dose may benefit from dose
up-titrations.
Therapeutic response is usually seen after 2-4 weeks of treatment.
3
After consolidation of the antidepressive response, it is recommended
to continue treatment for several
months, in order to avoid relapse. In patients responding to
duloxetine, and with a history of repeated
episodes of major depression, further long-term treatment at a dose of
60 to 120 mg/day could be
considered.
_Generalised anxiety disorder_
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