Duloxetine Boehringer Ingelheim

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

duloxetine

Tilgængelig fra:

Boehringer Ingelheim International GmbH

ATC-kode:

N06AX21

INN (International Name):

duloxetine

Terapeutisk gruppe:

Psychoanaleptics,

Terapeutisk område:

Diabetic Neuropathies

Terapeutiske indikationer:

Treatment of diabetic peripheral neuropathic pain in adults.

Produkt oversigt:

Revision: 2

Autorisation status:

Withdrawn

Autorisation dato:

2008-10-08

Indlægsseddel

Medicinal product no longer authorised
38
B. PACKAGE LEAFLET
Medicinal product no longer authorised
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE BOEHRINGER INGELHEIM
30 MG
HARD GASTRO-RESISTANT CAPSULES
DULOXETINE BOEHRINGER INGELHEIM 60 MG
HARD GASTRO-RESISTANT CAPSULES
Duloxetine (as hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist
IN THIS LEAFLET
:
1.
What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for
2.
Before you take DULOXETINE BOEHRINGER INGELHEIM
3.
How to take DULOXETINE BOEHRINGER INGELHEIM
4.
Possible side effects
5
How to store DULOXETINE BOEHRINGER INGELHEIM
6.
Further information
1.
WHAT DULOXETINE BOEHRINGER INGELHEIM IS AND WHAT IT IS USED FOR
DULOXETINE BOEHRINGER INGELHEIM increases the levels of serotonin and
noradrenaline in
the nervous system.
DULOXETINE BOEHRINGER INGELHEIM 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).
The effect of DULOXETINE BOEHRINGER INGELHEIM may be noticeable in
many patients with
diabetic neuropathic pain within 1 week of treatment.
2.
BEFORE YOU TAKE DULOXETINE BOEHRINGER INGELHEIM
DO NOT TAKE DULOXETINE BOEHRINGER INGELHEIM IF YOU:
−
are allergic (hypersensitive) to duloxetine or any of the other
ingredients of DULOXETINE
BOEHRINGER INGELHEIM
−
have liver disease
−
have severe kidney disease are taking or have recently taken within
the last 14 days, another
antidepressan

Produktets egenskaber

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride)
Excipients: sucrose 8.6 mg.
For a 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 in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
_Adults _
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 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).
_Elderly _
No dosage adjustment is recommended for elderly patients solely on the
basis of age. However,
caution should be exercised when treating the elderly (see section
5.2).
_Children and adolescents _
There is no experience in children and adolescents (see section 4.4).
_ _
_Hepatic impairment_
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with
liver disease
resulting in hepatic impairment (see sections 4.3 and 5.2).
Medicinal product no longer authorised
3
_Renal insufficiency _
No dosage adjustment is necessary for patients with mild or moderate
renal dysfunction (creatinine
clear