DULOXETINE SANDOZ 30 MG GRC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DULOXETINE AS HYDROCHLORIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

N06AX21

Pharmaceutical form:

GASTRO RESISTANT CAPSULES

Composition:

DULOXETINE AS HYDROCHLORIDE 30 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SALUTAS PHARMA GMBH, GERMANY

Therapeutic area:

DULOXETINE

Therapeutic indications:

Duloxetine Sandoz is indicated for - The treatment of major depressive episodes.- The management of neuropathic pain associated with diabetic peripheral neuropathy.- The treatment of generalized anxiety disorder (GAD).- The management of fibromyalgia.- 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.

Authorization date:

2021-06-23

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DULOXETINE SANDOZ
®
30 MG GRC
Gastro-resistant capsules
DULOXETINE SANDOZ
®
60 MG GRC
Gastro-resistant capsules
ACTIVE INGREDIENT:
duloxetine (as hydrochloride) 30 mg
ACTIVE INGREDIENT:
duloxetine (as hydrochloride) 60 mg
INACTIVE
INGREDIENTS
AND
ALLERGENS
IN
THIS
MEDICINE:
See
_‘Important _
_information about some of this medicine’s ingredients’_ in
section 2 and section 6
_‘Additional _
_information’_.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar
to 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
depression,
suicidal thoughts, aggressiveness etc.
If changes such as these occur, contact the doctor immediately.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Duloxetine Sandoz GRC is used to treat adults who have:
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: Duloxetine Sandoz GRC belongs to a class of
medicines
called SNRI and causes an increase in serotonin and noradrenaline
levels.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
you are sensitive (allergic) to the acti