PRAMISON (Pramipexole Tablets 0.125mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Unit dalam pakej:

3 x10 Tablets; 10 x 10 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Risalah maklumat

PRAMISON (PRAMIPEXOLE TABLETS 0.125 MG)
PRAMISON ( PRAMIPEXOLE TABLETS 0.25 MG)
PRAMISON ( PRAMIPEXOLE TABLETS 1 MG)
Pramipexole Dihydrochloride Monohydrate (0.125mg, 0.25mg and 1mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What PRAMISON is used for
2.
How PRAMISON works
3.
Before you use PRAMISON
4.
How to use PRAMISON
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
PRAMISON Product Description
8.
Manufacturer
and
Product
Registration Holder
9.
Date of revision
WHAT PRAMISON IS USED FOR
PRAMISON used to treat the sign and
symptoms
of
advanced
idiopathic
parkinson’s disease in adults. It can be
used
alone
or
in
combination
with
levodopa
(another
medicine
for
Parkinson’s disease). PRAMISON is also
used to treat the symptoms of idiopathic
Restless Legs Syndrome.
HOW PRAMISON WORKS
PRAMISON
contains
the
active
ingredient Pramipexole which is a highly
selective dopamine receptor activator in
the
brain.
PRAMISON
alleviates
parkinsonian
motor
deficits
by
stimulation of dopamine receptors in the
brain.
Pramipexole
protect
dopamine
neurons from degeneration in response to
low
oxygen
or
methamphetamine
neurotoxicity.
BEFORE YOU USE PRAMISON
-When you must not use it
If
you
are
pregnant
or
breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
for advice before taking this medicine.
Your doctor will then discuss with you if
you
should
continue
to
take
PRAMISON. The effect of PRAMISON
on
the
unborn
child
is
not
known.
Therefore, do not take PRAMISON if
you are pregnant unless your doctor tells
you to do so. PRAMISON should not be
used during breastfeeding. PRAMISON
can reduce the production of breast milk.
Also, it can pass into the breast milk and
can
reach
your
baby.
If
use
of
PRAMISON
is
unavoidable,
breast-
feeding should be stopped.
-
Before you start use it
Do
not
take
PRAMISON
if
you
are
allergic to pramipexole or to any of the
other ingredients of this medicine.
WARNING AND PRECAUTION FOR USE
PRAMISON
has
been
associate

Ciri produk

PRAMISON (PRAMIPEXOLE TABLETS 0.125MG)
PRAMISON (PRAMIPEXOLE TABLETS 0.25MG)
PRAMISON (PRAMIPEXOLE TABLETS 0.1MG)
Each tablet in the form of uncoated tablet.
DESCRIPTION
Pramison Tablets 0.125mg (Pramipexole 0.088mg)
White to off-white, round, flat, bevelled edge uncoated tablets,
debossed with ‘Y’ on one side
‘41’ on the other side with the presence of score line and the
dimension of the tablet is
5.5mm.
Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate
0.125 mg.
Pramison Tablet 0.25mg (Pramipexole 0.18mg)
White to off-white, oval, biconcave, bevelled edge uncoated tablets,
debossed with ‘Y’ and
‘42’ separated by score line on one side and plain with score line
on other side and the
dimension of the tablet is 6.5mm x 4.5mm
Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate
0.25 mg
Pramison Tablet 1mg (Pramipexole 0.7mg)
White to off-white, round, flat, bevelled edge uncoated tablets
debossed with ‘Y’ and ‘45’
separated by score line on one side and plain with score line on other
side and the dimension
of the tablet is 9.3mm.
Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate
1 mg
PHARMACODYNAMICS
Pramipexole, active ingredient of PRAMISON is a dopamine-agonist and
binds with high
selectivity and specificity to the dopamine D2-subfamily receptors and
has a preferential
affinity to D3-receptors; it has full intrinsic activity. PRAMISON
alleviates parkinsonian
motor deficits by stimulation of dopamine receptors in the striatum.
Pramipexole protect
dopamine neurons from degeneration in response to ischaemia or
methamphetamine
neurotoxicity. The precise mechanism of action of PRAMISON as a
treatment for restless leg
syndrome (RLS) is not known. Although the pathophysiology of RLS is
largely unknown,
neuropharmacological evidence suggests primary dopaminergic system
involvement.
Positron emission tomographic studies suggest that a mild striatal
presynaptic dopaminergic
dysfunction may be involved in the pathogenesis of RLS.
PHARMACOKINET