Duloxetin Teva 20 mg Enterokapsel, hård

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

duloxetinhydroklorid

Tillgänglig från:

Teva B.V.

ATC-kod:

N06AX21

INN (International namn):

duloxetine hydrochloride

Dos:

20 mg

Läkemedelsform:

Enterokapsel, hård

Sammansättning:

propylenglykol Hjälpämne; duloxetinhydroklorid 22,4 mg Aktiv substans; sockersfärer Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 28 kapslar; Burk, 98 kapslar; Blister, 7 kapslar; Blister, 100 kapslar; Blister, 56 kapslar; Blister, 30 kapslar; Blister, 28 kapslar; Blister, 10 kapslar; Blister, 98 kapslar

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-10-18

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
{Product name} 20 mg hard gastro-resistant capsules
{Product name} 40 mg hard gastro-resistant capsules
[Product name in RMS: Duloxetin Teva]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains duloxetine hydrochloride equivalent to 20 mg
duloxetine.
Each capsule contains duloxetine hydrochloride equivalent to 40 mg
duloxetine.
Excipient with known effect
Each 20 mg capsule contains 67 mg sucrose.
Excipient with known effect
Each 40 mg capsule contains 134 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule
Opaque blue body imprinted with ‘DLX 20’ and an opaque blue cap
imprinted with ‘DLX 20’, length 16
mm.
Opaque yellow body imprinted with ‘DLX 40’ and an opaque yellow
cap imprinted with ‘DLX 40, length 19
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{Product name} is indicated for women for the treatment of moderate to
severe Stress Urinary Incontinence
(SUI).
{Product name} is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of duloxetine is 40 mg twice daily without regard
to meals. After 2-4 weeks of
treatment, patients should be re-assessed in order to evaluate the
benefit and tolerability of the therapy. Some
patients may benefit from starting treatment at a dose of 20 mg twice
daily for two weeks before increasing
to the recommended dose of 40 mg twice daily. Dose escalation may
decrease, though not eliminate, the risk
of nausea and dizziness.
{Product name} is available in 20 mg and 40 mg capsules. However,
limited data are available to support the
efficacy of duloxetine 20 mg twice daily.
2
The efficacy of duloxetine has not been evaluated for longer than 3
months in placebo-controlled studies.
The benefit of treatment should be re-assessed at regular intervals.
Combining {Product name} with a pelvic floor muscle training (PFMT)
programme may be more