Duloxetin Teva B.V. 30 mg Enterokapsel, hård

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

duloxetinhydroklorid

Saatavilla:

Teva B.V.

ATC-koodi:

N06AX21

INN (Kansainvälinen yleisnimi):

duloxetine hydrochloride

Annos:

30 mg

Lääkemuoto:

Enterokapsel, hård

Koostumus:

sockersfärer Hjälpämne; duloxetinhydroklorid 33,7 mg Aktiv substans; propylenglykol Hjälpämne

Prescription tyyppi:

Receptbelagt

Tuoteyhteenveto:

Förpacknings: Burk, 100 kapslar; Blister, 7 kapslar; Blister, 100 kapslar; Blister, 98 kapslar; Blister, 56 kapslar; Blister, 30 kapslar; Blister, 28 kapslar; Blister, 14 kapslar

Valtuutuksen tilan:

Godkänd

Valtuutus päivämäärä:

2019-10-18

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
{Product name} 30 mg hard gastro-resistant capsules
{Product name} 60 mg hard gastro-resistant capsules
[Product name in RMS: Duloxetin Teva B.V.]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains duloxetine hydrochloride equivalent to 30 mg
duloxetine.
Each capsule contains duloxetine hydrochloride equivalent to 60 mg
duloxetine.
Excipient with known effect
Each 30 mg capsule contains 101 mg sucrose.
Excipient with known effect
Each 60 mg capsule contains 201 mg sucrose.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule
Opaque grey body imprinted with ‘DLX 30’ and an opaque blue cap
imprinted with ‘DLX 30’, length 18
mm.
Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap
imprinted with ‘DLX 60’, length 20
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
{Product name} 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.
2
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
The recommended starting dose in patients with generalised anxiety
disorder is