Duloxetine Rowa 30mg hard gastro-resistant capsules

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Duloxetine hydrochloride

Dostopno od:

Rowa Pharmaceuticals Limited

Koda artikla:

N06AX; N06AX21

INN (mednarodno ime):

Duloxetine hydrochloride

Odmerek:

30 milligram(s)

Farmacevtska oblika:

Gastro-resistant capsule

Tip zastaranja:

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

Terapevtsko območje:

Other antidepressants; duloxetine

Status dovoljenje:

Marketed

Datum dovoljenje:

2017-09-01

Navodilo za uporabo

1
WHAT DULOXETINE ROWA IS AND
WHAT IT IS USED FOR
Duloxetine Rowa contains the active substance
duloxetine. Duloxetine Rowa increases the levels
of serotonin and noradrenaline in the nervous
system.
Duloxetine Rowa 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 Rowa 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 Rowa 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 TO KNOW BEFORE
YOU TAKE DULOXETINE ROWA
DO NOT TAKE DULOXETINE ROWA:
− If you are allergic to duloxetine or any of the
other ingredients of this medicine (listed in
section 6)
− If you have liver disease
− If you have severe kidney disease
− If you are taking or have taken within the
last 14 days, another medicine known as a
monoamine oxidase inhibitor (MAOI) (see
‘Other medicines and Duloxetine Rowa’)
− If you are taking fluvoxamine which is usually
used to treat depression, ciprofloxacin or
enoxacin which are used to treat some
infections
− If you are taking other medicines containing
duloxetine (see ‘Other medicines and
Duloxetine Rowa’)
Talk to your doctor if you have high blood
pressure or heart disease. Your doctor will tell
you if you should be taking Duloxetine Rowa.
WARNINGS AND PRECAUTIONS
The following are reasons why Duloxetine Rowa
may not be suitable for you. Talk to your doctor
before yo

Lastnosti izdelka

Health Products Regulatory Authority
04 September 2020
CRN009T5H
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Rowa 30mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains from 52,38 to 70,92 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Hard gelatin capsule #3, ink-printed in yellow with “DLX” on the
opaque blue cap and “30 mg” on the opaque white body.
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 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 usual maintenance dose in most
patients.
In patients with co-morbid major depressive disor