Duloxetine Accord 60 mg hard gastro-resistant capsules

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Duloxetine hydrochloride

Հասանելի է:

Accord Healthcare Ireland Ltd.

ATC կոդը:

N06AX21

INN (Միջազգային անվանումը):

Duloxetine hydrochloride

Դեղագործական ձեւ:

Gastro-resistant capsule, hard

Թերապեւտիկ տարածք:

duloxetine

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2023-01-06

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE ACCORD 60 MG HARD GASTRO-RESISTANT
CAPSULES
Duloxetine (as hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Duloxetine Accord is and what it is used for
2.
What you need to know before you take Duloxetine Accord
3.
How to take Duloxetine Accord
4.
Possible side effects
5.
How to store Duloxetine Accord
6.
Contents of the pack and other information
1.
WHAT DULOXETINE ACCORD IS AND WHAT IT IS USED FOR
Duloxetine Accord contains the active substance duloxetine. Duloxetine
Accord increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine Accord is used in adults to treat:
•
depression
•
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
•
diabetic neuropathic pain (often described as burning, stabbing,
stinging, shooting or aching or
like an electric shock. There may be loss of feeling in the affected
area, or sensations such as
touch, heat, cold or pressure may cause pain)
Duloxetine Accord starts to work in most people with depression or
anxiety within two weeks of
starting treatment, but it may take 2-4 weeks before you feel better.
Tell your doctor if you do not start
to feel better after this time. Your doctor may continue to give you
Duloxetine Accord when you are
feeling better to prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain, it can take some weeks
before you feel better. Talk to your
doctor if you do not feel better a

Ապրանքի հատկությունները

Health Products Regulatory Authority
06 January 2023
CRN00D3G3
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Accord 60 mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule, hard contains 60 mg of duloxetine (as
hydrochloride).
Excipient(s) with known effect:
Each gastro-resistant capsule, hard contains approximately 119.2 -
135.6 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque blue cap and opaque green body capsules printed (cap E/body
129) of 19 mm approximately, filled with off-white to
beige/salmon spherical pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Accord 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 recommended starting dose in patients with generalised anxiety
disorder is 30 mg once daily with or without food. In
patients with insufficient response the dose should be increased to 60
mg, which is the us