CYMBALTA 60 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

DULOXETINE AS HYDROCHLORIDE

Disponible des:

ELI LILLY ISRAEL LTD

Codi ATC:

N06AX21

formulario farmacéutico:

GASTRO RESISTANT CAPSULES

Composición:

DULOXETINE AS HYDROCHLORIDE 60 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

LILLY S.A., SPAIN

Grupo terapéutico:

DULOXETINE

Área terapéutica:

DULOXETINE

indicaciones terapéuticas:

Cymbalta is indicated for the treatment of major depressive episodes.- Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.- Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD).- Cymbalta is indicated for the management of fibromyalgia.- Cymbalta is indicated for the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis.

Data d'autorització:

2015-03-31

Fitxa tècnica

X CYMBCP A 14
1 of 28
ב הרשואש יפכ ,אתכמסאהמ (שרדנש לככ
,טמרופהו לארשיב םושירה יאנתל המאתה
דבלמ) ונושלכ ץמוא ,שגומה ןולעה ןוכדע
US
ךיראתב
13.12.17
_ _
GASTRO RESISTANT CAPSULES
CAPSULES
MG
30
®
CYMBALTA
GASTRO RESISTANT CAPSULES
CAPSULES
MG
60
®
CYMBALTA
FULL PRESCRIBING INFORMATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-
TERM STUDIES. THESE STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF
SUICIDAL THOUGHTS AND BEHAVIOR WITH ANTIDEPRESSANT USE
IN PATIENTS OVER AGE 25; THERE WAS A REDUCTION IN RISK WITH
ANTIDEPRESSANT USE IN PATIENTS AGED 65 AND OLDER _[SEE WARNINGS _
_AND PRECAUTIONS (5.1)]_. IN PATIENTS OF ALL AGES WHO ARE STARTED ON
ANTIDEPRESSANT THERAPY MONITOR CLOSELY FOR WORSENING, AND
FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. ADVISE FAMILIES AND
CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND
COMMUNICATION WITH THE PRESCRIBER. CYMBALTA IS NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS _[SEE_ _USE IN SPECIFIC POPULATIONS _
_(8.4)]_.
1
INDICATIONS AND USAGE
Cymbalta is indicated for the treatment of major depressive episodes.
- Cymbalta is indicated for the management of neuropathic pain
associated with diabetic peripheral neuropathy.
- Cymbalta is indicated for the treatment of generalized anxiety
disorder (GAD).
- Cymbalta is indicated for the management of fibromyalgia.
- Cymbalta is indicated for the management of chronic muscoskeletal
pain when other therapies have failed or are contra-indicated.
This has been established is studies in patients with chronic low back
pain (CLBP) and chronic pain due to
Osteoarthritis.
2
DOSAGE AND ADMINISTRATION
Swallow CYMBALTA whole . Do not chew or crush. Do not open the capsule
and sprinkle its contents on food or mix with
liquids. All of these might affect the enteric coating. Cymbalta
should not be administered through a gastric tube either because t