Nodetrip (previously Xeristar)
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
22-06-2021
Valmisteyhteenveto
(SPC)
22-06-2021
Julkisesta arviointikertomuksesta
(PAR)
22-06-2021
Aktiivinen ainesosa:
duloxetine
Saatavilla:
Esteve Pharmaceuticals, S.A.
ATC-koodi:
N06AX21
INN (Kansainvälinen yleisnimi):
duloxetine
Terapeuttinen ryhmä:
Psychoanaleptics,
Terapeuttinen alue:
Anxiety Disorders; Depressive Disorder, Major; Diabetic Neuropathies
Käyttöaiheet:
Treatment of major depressive disorder;Treatment of diabetic peripheral neuropathic pain;Treatment of generalised anxiety disorder;Xeristar is indicated in adults.
Tuoteyhteenveto:
Revision: 32
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2004-12-17
Pakkausseloste
34
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
NODETRIP
30 MG
HARD GASTRO-RESISTANT CAPSULES
NODETRIP 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 Nodetrip is and what it is used for
2.
What you need to know before you take Nodetrip
3.
How to take Nodetrip
4.
Possible side effects
5.
How to store Nodetrip
6.
Contents of the pack and other information
1.
WHAT NODETRIP IS AND WHAT IT IS USED FOR
Nodetrip contains the active substance duloxetine. Nodetrip increases
the levels of serotonin and
noradrenaline in the nervous system.
Nodetrip 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)
Nodetrip 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 Nodetrip
when you are feeling better to
prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain it can take some weeks before
you feel better. Talk to your
doctor if you do not fe
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Nodetrip 30 mg hard gastro-resistant capsules
Nodetrip 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nodetrip 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.
Nodetrip 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.
Nodetrip 30 mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Nodetrip 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.
Nodetrip 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.
Medicinal Product no longer authorised
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
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