Duloxetine Rowex 60 mg Gastro-resistant capsules, hard

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Duloxetine hydrochloride

Saadav alates:

Rowex Ltd

ATC kood:

N06AX; N06AX21

INN (Rahvusvaheline Nimetus):

Duloxetine hydrochloride

Annus:

60 milligram(s)

Ravimvorm:

Gastro-resistant capsule

Retsepti tüüp:

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

Terapeutiline ala:

Other antidepressants; duloxetine

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2016-03-24

Infovoldik

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

Toote omadused

Health Products Regulatory Authority
21 April 2021
CRN00C785
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Rowex 60 mg Gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant hard capsule contains 60 mg of duloxetine (as
hydrochloride).
Excipient(s) with known effect
Each gastro-resistant hard capsule contains 0.152 mg of Sunset Yellow
FCF (E 110), 3.7 mg of lactose (as monohydrate) and
0.390 mg of Allura Red AC (E 129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant hard capsule.
Opaque yellowish green body capsule, imprinted with '60' and an opaque
dark blue cap containing 8 white to off white, round,
biconvex tablets.
Capsule size: approximately 24 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 Rowex 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