Ariclaim
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
07-08-2018
Karatteristiċi tal-prodott
(SPC)
07-08-2018
Rapport ta 'Valutazzjoni Pubblika
(PAR)
07-08-2018
Ingredjent attiv:
duloxetine
Disponibbli minn:
Eli Lilly Nederland B.V.
Kodiċi ATC:
N06AX21
INN (Isem Internazzjonali):
duloxetine
Grupp terapewtiku:
Psychoanaleptics,
Żona terapewtika:
Diabetic Neuropathies
Indikazzjonijiet terapewtiċi:
Treatment of diabetic peripheral neuropathic pain.Ariclaim is indicated in adults.
Sommarju tal-prodott:
Revision: 26
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2004-08-11
Fuljett ta 'informazzjoni
40
B. PACKAGE LEAFLET
Medicinal product no longer authorised
41 PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICLAIM
30 MG
HARD GASTRO-RESISTANT CAPSULES
ARICLAIM 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.
WHAT IS IN THIS LEAFLET
:
1.
What ARICLAIM is and what it is used for
2.
What you need to know before you take ARICLAIM
3.
How to take ARICLAIM
4.
Possible side effects
5.
How to store ARICLAIM
6.
Contents of the pack and other information
1.
WHAT ARICLAIM IS AND WHAT IT IS USED FOR
ARICLAIM contains the active substance duloxetine. ARICLAIM increases
the levels of serotonin
and noradrenaline in the nervous system.
ARICLAIM is used in adults to treat a condition called 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).
In people with diabetic neuropathic pain it can take some weeks before
you feel better. Talk to your
doctor if you do not feel better after 2 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARICLAIM
DO NOT TAKE ARICLAIM 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 inhibitor (MAOI) (see ‘Other medicines and ARICLAIM’)
−
are taking fluvoxamine
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
ARICLAIM 30 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule may contain up to 56 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetic peripheral neuropathic pain.
ARICLAIM is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting and recommended maintenance dose is 60 mg daily with or
without food. Dosages above
60 mg once daily, up to a maximum dose of 120 mg per day administered
in evenly divided doses,
have been evaluated from a safety perspective in clinical trials. The
plasma concentration of
duloxetine displays large inter-individual variability (see section
5.2). Hence, some patients that
respond insufficiently to 60 mg may benefit from a higher dose.
Response to treatment should be evaluated after 2 months. In patients
with inadequate initial response,
additional response after this time is unlikely.
The therapeutic benefit should be reassessed regularly (at least every
three months) (see section 5.1).
_Paediatric population _
The safety and efficacy of duloxetine for the treatment of diabetic
peripheral neuropathic pain has not
been studied. No data are available.
_ _
_Special populations _
_Elderly _
No dosage adjustment is recommended for elderly patients solely on the
basis of age. However, as
with any medicine, caution should be exercised when treating the
elderly (see section 5.2).
Medicinal product no longer authorised
3
_ _
_Hepatic impairment_
ARICLAIM must not be used in patients with liver disease resulting in
hepatic impairment (see
sections 4
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