Duloxetine 60 mg gastro-resistant capsules

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Duloxetine hydrochloride

Commercializzato da:

Accord Healthcare Ireland Ltd.

Codice ATC:

N06AX; N06AX21

INN (Nome Internazionale):

Duloxetine hydrochloride

Dosaggio:

60 milligram(s)

Forma farmaceutica:

Gastro-resistant capsule, hard

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Other antidepressants; duloxetine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2015-06-19

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE 30 MG GASTRO-RESISTANT CAPSULES
DULOXETINE 60 MG 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
is and what it is used for
2.
What you need to know before you take Duloxetine
3.
How to take Duloxetine
4.
Possible side effects
5.
How to store Duloxetine
6.
Contents of the pack and other information
1.
WHAT DULOXETINE
IS AND WHAT IT IS USED FOR
Duloxetine
contains the active substance duloxetine. Duloxetine
increases the levels of serotonin and
noradrenaline in the nervous system.
Duloxetine
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
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
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 after 2 months.
2.
WHAT YOU NEED

Scheda tecnica

Health Products Regulatory Authority
26 April 2021
CRN00C9MP
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine 60 mg gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient with known effect: Each capsule contains 201.3 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap
imprinted with ‘DLX 60’, length 20.4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine 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 anti-depressive 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 usual maintenance dose in most
patients.
In patients with co‑morbid major depressive disorder, the starting
and maintenance dose i