MACXETINE 30MG CAPSULE (DULOXETINE DELAYED RELEASE CAPSULES 30MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DULOXETINE HYDROCHLORIDE

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

DULOXETINE HYDROCHLORIDE

Unit dalam pakej:

100 Capsules; 30 Capsules

Dikeluarkan oleh:

Macleods Pharmaceuticals Limited

Risalah maklumat

MACXETINE 30MG/60MG CAPSULE
_ _
DULOXETINE DELAYED RELEASE CAPSULE 30/60MG
Page 1 of 3
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET?
1. What Macxetine is used for
2. How Macxetine works
3. Before you use Macxetine
4. How to use Macxetine
5. While you are using Macxetine
6. Side effects
7. Storage and Disposal of Macxetine
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
1. WHAT MACXETINE IS USED FOR:
Duloxetine is used 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.
2. HOW MACXETINE WORKS:
Macxetine contains the active ingredient
duloxetine.
Duloxetine
increases
the
levels of serotonin and noradrenaline in
the nervous system. Duloxetine 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
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
3. BEFORE YOU USE MACXETINE:
_When you must not use it _
•
If you are allergic to duloxetine or any
of
the
other
ingredients
of
this
medicine.
•
If you have liver disease
•
If you have severe kidney disease
•
If you are taking fluvoxamine which is
usually used to treat depression.
_- Before you start to use it _
Talk to your doctor or pharmacist before
taking Macxetine
.
Take special care:
•
If you are taking other medicines to
treat depression
•
If you are taking St. John’s Wort, a
herbal
treatment
(Hypericum
perforatum)
•
If you have kidney disease
•
If you have had seizures (fits)
•
If you have had mania
•
If you suffer from bipolar di

Ciri produk

164 MM
14 MM
186 MM
16 MM
20 MM
30 MM
200 MM
320 MM
DOSAGE
Ÿ
Management of neuropathic pain associated with diabetic peripheral
neuropathy in
adults.
Ÿ
Treatment of major depressive disorder.
Oral
_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 persepective. 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.
_RENAL IMPAIRMENT:_ End stage renal disease (ESRD) patients receiving
dialysis had 2-fold
higher Duloxetine C
and AUC values.
max
Ÿ
Treatment of generalised anxiety disorder.
_Renal impairment: _
ROUTE OF ADMINISTRATION
_Generalized Anxiety Disorder_ :
_Elderly_: No dosage adjustment is recommended for elderly patients
solely on the basis of age.
However, as with any medicine, caution should be exercised when
treating the elderly,
especially with Duloxetine 120 mg per day for major depressive
disorder or generalised
anxiety disorder, for which data are limited.
_Hepatic impairment: _
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 disorder, the starting and maintenance dose is 60 mg
once daily (please see
also dosing recommendation above). Doses up to 120 mg per day have
been shown to be
efficacious and have been evaluated