ONELAR 30MG HARD GASTRO-RESISTANT CAPSULES

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

DULOXETINE HYDROCHLORIDE

Commercializzato da:

KOMEDIC SDN BHD

INN (Nome Internazionale):

DULOXETINE HYDROCHLORIDE

Confezione:

100 Capsules; 28 Capsules

Prodotto da:

MEDOCHEMIE LTD (Factory AZ)

Foglio illustrativo

_Consumer Medication Information Leaflet (RiMUP) _
ONELAR
_Duloxetine (as hydrochloride) 30mg, 60mg _
WHAT IS IN THIS LEAFLET
1.
What ONELAR is used for
2.
How it works
3.
Before you use ONELAR
4.
How to use ONELAR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ONELAR
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT ONELAR IS USED FOR
ONELAR 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)
HOW ONELAR WORKS
ONELAR
contains
the
active
substance
duloxetine.
ONELAR
increases the levels of serotonin and
noradrenaline in the nervous system.
ONELAR 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 ONELAR
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.
BEFORE YOU USE ONELAR
_- When you must not use it _
Do not take ONELAR if you:
-
are allergic to duloxetine or any of
the
other
ingredients
of
this
medicine
(listed
in
Product
Description)
-
have liver disease
-
have severe kidney disease
-
are taking or have taken within the
last
14
days,
another
medicine
known
as
a
monoamine
oxidase
inhibitor
(MAOI)
(see
‘Taking
other medicines’)
-
are taking fluvoxamine
which is
usually
used
to
treat
depression,
ciprofloxacin
or
enoxacin
which
are used to treat some infections
-
are
taking
other
medicines
containing duloxetine (see ‘Taking
other medicines’)
Talk to your doctor

Scheda tecnica

PACKAGE INSERT – ONELAR
1.
NAME OF THE MEDICINAL PRODUCT
ONELAR 30 mg hard gastro-resistant capsules
ONELAR 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each 30 mg capsules contains 76.5 mg sucrose and 0.0009 mg carmoisine.
Each 60 mg capsules contains 153 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
ONELAR 30 mg: Hard gelatine capsules, size “3”, with white body
and blue cap containing off white pellets
ONELAR 60 mg: Hard gelatine capsules, size “0”, with light grey
body and pink cap containing off white pellets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of neuropathic pain associated with diabetic peripheral
neuropathy in adults.
Treatment of generalised anxiety disorder.
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 ma