Cymbalta capsules gastro-resistant

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

duloxetine (duloxetine hydrochloride)

थमां उपलब्ध:

Lilly S.A.

ए.टी.सी कोड:

N06AX21

INN (इंटरनेशनल नाम):

duloxetine (duloxetine hydrochloride)

डोज़:

30mg

फार्मास्यूटिकल फॉर्म:

capsules gastro-resistant

पैकेज में यूनिट:

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

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2021-08-04

सूचना पत्रक

EUSPC25JULY2019
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
Cymbalta 30 mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect_
Each capsule may contain up to 56 mg sucrose.
Cymbalta 60 mg
Each capsule contains 60 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect_
Each 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.
Cymbalta 30 mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Cymbalta 60 mg
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

उत्पाद विशेषताएं

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Cymbalta 30
mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect_
Each capsule may contain up to 56 mg sucrose.
Cymbalta 60
mg
Each capsule contains 60 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule may contain up to 111 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Cymbalta 30
mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Cymbalta 60
mg
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.
3
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 generalise