Duloxetine Krka 30 mg hard gastro-resistant capsules

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Duloxetine

Beschikbaar vanaf:

KRKA, d.d., Novo mesto

ATC-code:

N06AX; N06AX21

INN (Algemene Internationale Benaming):

Duloxetine

Dosering:

30 milligram(s)

farmaceutische vorm:

Gastro-resistant capsule, hard

Toedieningsweg:

Oral use

Eenheden in pakket:

: 7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box

Prescription-type:

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

Geproduceerd door:

KRKA, d.d.

Therapeutische categorie:

psychoanaleptics, other antidepressants

Therapeutisch gebied:

Other antidepressants; duloxetine

therapeutische indicaties:

Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.

Autorisatie-status:

Marketed

Autorisatie datum:

2015-03-13

Bijsluiter

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

Productkenmerken

Health Products Regulatory Authority
26 January 2022
CRN00CLM3
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Krka 30mg hard gastro-resistant capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 30 mg duloxetine (as
duloxetine hydrochloride).
Excipient with known effect: sucrose.
Each 30 mg hard gastro-resistant capsule contains up to 43 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsule
White to almost white pellets in a hard gelatine capsule size 3
(average length: 15.9 mm). The capsule body is white and the
cap dark blue. The capsule body is imprinted with 30 in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Krka 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 t