CYMBALTA CAPSULE 60MG

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Duloxetine hydrochloride (equivalent to base)

Dostupno od:

DKSH SINGAPORE PTE. LTD.

ATC koda:

N06AX21

Doziranje:

60.0 mg

Farmaceutski oblik:

CAPSULE

Sastav:

Duloxetine hydrochloride (equivalent to base) 60.0 mg

Administracija rute:

ORAL

Tip recepta:

Prescription Only

Proizveden od:

Lilly del Caribe, Inc. (PR01)

Status autorizacije:

ACTIVE

Datum autorizacije:

2006-03-07

Uputa o lijeku

1 
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 capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). 
For the full list of excipients, see section 6.1. 

3.
  PHARMACEUTICAL FORM 

Hard gastro-resistant capsule. 

The  30 mg  capsule  has  an  opaque  white  body,  imprinted  with  ‘30 mg’  and  an  opaque  blue  cap, 
imprinted with ‘9543’. 
The  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 generalised anxiety disorder. 
Treatment of diabetic peripheral neuropathic pain. 
Management of pain associated with fibromyalgia. 

Cymbalta is not indicated for use in children and adolescents below 18 years of age. 

4.2
 POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use, with or without food. Cymbalta should be swallowed whole and should not be chewed or 
crushed, nor should  the  capsule  be opened and its  contents  sprinkled on food or mixed with liquids. 
All of these might affect the enteric coating. 

_Major Depressive Disorder_

The  starting  and  recommended  maintenance  dose  is  60  mg  once  daily.  Dosages  above  60  mg  once 
daily,  up  to  a  maximum  dose  of  120  mg/day  administered  in  evenly  divided  doses,  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 fro

Svojstava lijeka

1.
NAME OF THE MEDICINAL PRODUCT
Cymbalta capsules 30mg
Cymbalta capsules 60mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cymbalta 30mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect_
Each capsule may contain up to 56 mg sucrose.
Cymbalta 60mg
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 30mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Cymbalta 60mg
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 generalised anxiety disorder.
Treatment of diabetic peripheral neuropathic pain.Management of pain
associated with fibromyalgia.
Cymbalta is not indicated for use in children and adolescents below 18
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use, with or without food. Cymbalta should be swallowed whole
and should not be chewed or crushed, nor
should the capsule be opened and its contents sprinkled on food or
mixed with liquids. All of these might affect the
enteric coating.
_Major depressive disorder_
The starting and recommended maintenance dose is 60 mg once daily.
Dosages above 60 mg once daily, up to a
maximum dose of 120 mg/day administered in evenly divided doses, 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 r