Cymbalta capsules gastro-resistant

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

duloxetine (duloxetine hydrochloride)

Доступно од:

Lilly S.A.

АТЦ код:

N06AX21

INN (Међународно име):

duloxetine (duloxetine hydrochloride)

Дозирање:

60mg

Фармацеутски облик:

capsules gastro-resistant

Јединице у пакету:

(7/1x7/) in blister, (14/2x7/) in blister, (14/1x14/) in blister, (28/4x7/) in blister, (28/2x14/) in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2019-06-28

Информативни летак

EUSPC 09JULY2015
CYMBALTA* 30 AND 60 MG HARD GASTRO-RESISTANT CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
CYMBALTA 30 mg hard gastro-resistant capsules
CYMBALTA 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg capsule contains 30 mg of duloxetine (as hydrochloride).
Each 60 mg capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each 30 mg capsule may contain up to 56 mg sucrose.
Each 60 mg capsule may contain up to 111 mg sucrose
For the full list of excipients, see section 6.1.
Not all strengths may be marketed.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
The CYMBALTA 30 mg capsule has an opaque white body, imprinted with
‘30 mg’ and an opaque blue
cap, imprinted with ‘9543’.
The CYMBALTA 60 mg capsule has an 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.
CYMBALTA 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.
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 reco

Карактеристике производа

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_Page 1 of 19 _
SUMMARY OF PRODUCT CHARACTERISTICS
EUSPC09JUL2015
_ _
_Page 2 of 19 _
1.
NAME OF THE MEDICINAL PRODUCT
CYMBALTA 30 mg hard gastro-resistant capsules
CYMBALTA 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg capsule contains 30 mg of duloxetine (as hydrochloride).
Each 60 mg capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each 30 mg capsule may contain up to 56 mg sucrose.
Each 60 mg capsule may contain up to111 mg sucrose
For the full list of excipients, see section 6.1.
Not all strengths may be marketed.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
The CYMBALTA 30 mg capsule has an opaque white body, imprinted with
‘30 mg’ and an opaque blue
cap, imprinted with ‘9543’.
The CYMBALTA 60 mg capsule has an 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.
CYMBALTA 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.
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.
_ _
_Page 3 of 19 _
_