DULEVE 30- Duloxetine Delayed Release Capsules USP 30mg

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

DULOXETINE HYDROCHLORIDE

Dostupno od:

UNIMED SDN BHD

INN (International ime):

DULOXETINE HYDROCHLORIDE

Jedinice u paketu:

3X10 Capsules

Proizveden od:

Zydus Lifesciences Limited

Uputa o lijeku

DULEVE 30 & DULEVE 60
Duloxetine Delayed Release Capsules USP (60mg and 30mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DULEVE capsule is used for
2.
How DULEVE capsule works
3.
Before you use DULEVE capsule
4.
How to use DULEVE capsule
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of DULEVE
capsule
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT DULEVE CAPSULE IS USED FOR
DULEVE 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 DULEVE CAPSULE WORKS
DULEVE contains the active ingredient
duloxetine. DULEVE increases the levels
of
serotonin
and
noradrenaline
in
the
nervous system.
DULEVE 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 DULEVE 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 DULEVE CAPSULE_ _
_When you must not use it_
_ _
DO NOT take DULEVE if you
_: _
•
Are allergic to duloxetine or any of
the other ingredients of this
medicine.
•
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 DULEVE.
-
_ Before you start to use it _
The following are reasons why DULEVE
may not be suitable for you. Talk to your
doctor before you take DULEVE if you:
•
have k

Svojstava lijeka

1. NAME OF THE MEDICINAL PRODUCT
DULEVE 30
Duloxetine Delayed Release Capsules USP 30mg
DULEVE 60
Duloxetine Delayed Release Capsules USP 60mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DULEVE 30
Duloxetine Delayed Release Capsules USP 30mg
Each hard gelatin capsule contains:
Duloxetine Hydrochloride USP 33.680mg
Equivalent to Duloxetine 30mg
(as enteric coated pellets)
Approved colours used in capsule shell.
DULEVE 60
Duloxetine Delayed Release Capsules USP 60mg
Each hard gelatin capsule contains:
Duloxetine Hydrochloride USP 67.360mg
Equivalent to Duloxetine 60mg
(as enteric coated pellets)
Approved colours used in capsule shell.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard Gelatin capsule (Delayed Release Capsule)
DULOXETINE DELAYED RELEASE CAPSULES USP 30MG: Pink colored free
flowing pellets filled in size ‘3’ hard gelatin capsule
with opaque blue cap & opaque white body. The Capsule should be free
of all physical defects.
DULOXETINE DELAYED RELEASE CAPSULES USP 60MG: Pink colored free
flowing pellets filled in size ‘1’ capsule with opaque
blue cap & opaque green body. The Capsule should be free of all
physical defects.
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. 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