CYMBALOX 60 mg Delayed-Release Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DULOXETINE HYDROCHLORIDE

Boleh didapati daripada:

GENPHARMA SDN. BHD

INN (Nama Antarabangsa):

DULOXETINE HYDROCHLORIDE

Unit dalam pakej:

4 x 7 Capsules

Dikeluarkan oleh:

Alembic Pharmaceuticals Limited (Formulation Division)

Risalah maklumat

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CYMBALOX DELAYED- RELEASE CAPSULES
DULOXETINE (30MG, 60MG)
_____________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.What Cymbalox is used for
2.How Cymbalox works
3.Before you use Cymbalox
4.How to use Cymbalox
5.While you are using it
6.Side effects
7.Storage and Disposal of
Cymbalox
8.Product Description
9.Manufacturer and Product
Registration Holder
10.Date of revision
WHAT CYMBALOX IS USED FOR
Cymbalox is used in adults to treat:
•depression
•generalised anxiety disorder
•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 CYMBALOX WORKS
Cymbalox
contains
the
active
ingredient
duloxetine.
Cymbalox
increases the levels of serotonin and
noradrenaline in the nervous system.
Cymbalox 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 Cymbalox
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 CYMBALOX
-
_When you must not use it_
DO NOT take Cymbalox if you:
•are allergic to duloxetine or any of
the other ingredients of this
medicine (listed in section
PRODUCT
DESCRIPTION
)
•have liver disease
•have severe kidney disease
•have uncontrolled high blood
pressure
Talk to your doctor if you have high
blood pressure or heart disease.
Your doctor will tell you if you
should be taking Cymbalox.
-
_Before you start to use it_
The
following
are
reasons
why
Cymbalox may not be suitable for
you. Talk to your docto

Ciri produk

CYMBALOX 30MG DELAYED-RELEASE CAPSULES
CYMBALOX 60MG DELAYED-RELEASE CAPSULES
(Duloxetine Hydrochloride Delayed-Release capsules)
1.
NAME OF THE MEDICINAL PRODUCT
Cymbalox 30 mg Delayed-Release Capsules
Cymbalox 60 mg Delayed-Release Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hard Gelatin capsule contains:
Duloxetine Hydrochloride Ph. Eur Eq. to Duloxetine 30 mg
Duloxetine Hydrochloride Ph. Eur Eq. to Duloxetine 60 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
CYMBALOX 30 MG DELAYED-RELEASE CAPSULES
Opaque blue/opaque white, hard gelatin capsule size “3”, having
imprinting “157” on body with green ink and “A” on cap with
green ink and lled with white to off white coloured pellets.
CYMBALOX 60 MG DELAYED-RELEASE CAPSULES
Opaque blue/opaque green, hard gelatin capsule size “1”, having
imprinting “158” on body with white ink and “A” on cap with
white ink and lled with white to off white coloured pellets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Management 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. Doses 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 benet 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.