CYMBALTA 60 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

DULOXETINE AS HYDROCHLORIDE

Tilgængelig fra:

ELI LILLY ISRAEL LTD, ISRAEL

ATC-kode:

N06AX21

Lægemiddelform:

GASTRO RESISTANT CAPSULES

Sammensætning:

DULOXETINE AS HYDROCHLORIDE 60 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

LILLY S.A., SPAIN

Terapeutisk område:

DULOXETINE

Terapeutiske indikationer:

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.

Autorisation dato:

2015-05-19

Indlægsseddel

I CYMBCP A 18
Page 1 of 12
Patient Package Leaflet in Accordance
WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
Cymbalta
30 mg
Gastro-resistant capsules
Cymbalta
60 mg
Gastro-resistant capsules
Active ingredient:
duloxetine (as hydrochloride) 30 mg
Active ingredient:
duloxetine (as hydrochloride) 60 mg
Inactive ingredients and allergens in the preparation: See Chapter 2
section “Important
information about some of the ingredients of this medicine” and
Chapter 6 “Additional
information”.
Read the entire leaflet carefully before using this medicine. This
leaflet contains concise
information about this medicine. If you have any further questions,
contact your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It
may harm them, even if their illness seems to be the same as yours.
Antidepressants and antianxiety medicines increase the risk of
suicidal behavior and thoughts
among children, adolescents and young adults up to 24 years of age.
When beginning treatment with this medicine, patients of all ages and
their relatives, must
monitor behavioral changes such as worsening of depression, suicidal
thoughts,
aggressiveness etc.
If changes such as these occur, contact the doctor immediately.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Cymbalta is used to treat adults suffering from:

major depressive episodes

neuropathic pain associated with peripheral diabetic neuropathy

generalized anxiety disorder (GAD)

fibromyalgia

chronic musculoskeletal 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.
Therapeutic group: Cymbalta belongs to the SNRI family of drugs and
causes an increase in
the serotonin and noradrenaline levels.
2. BEFORE USING THIS MEDICINE
Do not use this medicine if:

you are sensitive (allergic) to the activ

Produktets egenskaber

X CYMBCP A 18
Page
1
of
34
30 mg capsules gastro resistant capsules
®
CYMBALTA
gastro resistant capsules
capsules
mg
60
®
CYMBALTA
Active substance: duloxetine (as hydrochloride)
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 24
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 _[see Warnings and _
_Precautions (5.1)]_._ _Cymbalta is not approved for use in pediatric
patients.
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
2.1 Important Administration Instructions
Administer CYMBALTA orally (with or without meals) and swallow whole.
Do not chew or crush, and do not open the
capsule and sprinkle its contents on food or mix with liquids because
these actions might affect the enteric coating.
Cymbalta should not be administered through a gastric tube either
because the pellets may obstruct the tube. If a dose of
CYMBALTA i