Pramexol 0.25mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Units in package:

3 x 10 Tablets

Manufactured by:

UNISON LABORATORIES CO.LTD

Patient Information leaflet

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_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PRAMEXOL TABLET
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (0.25 MG, 1 MG) 1
WHAT IS IN THIS LEAFLET
1.
What Pramexol is used for
2.
How Pramexol works
3.
Before you use Pramexol
4.
How to use Pramexol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Pramexol
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PRAMEXOL IS USED FOR
Treat
the
symptoms
of
primary
Parkinson’s disease
_1_
in adults. It can
be used alone or in combination with
Levodopa
(another
medicine
for
Parkinson’s
disease).
Also,
to
treat
idiopathic Restless Legs Syndrome (a
common
condition
of
the
nervous
system that causes an overwhelming,
irresistible urge to move the legs).
HOW PRAMEXOL WORKS
Pramexol
contains
the
active
substance
Pramipexole.
Pramipexole
belongs
to
a
group
of
medicines
known as dopamine agonists, which
stimulates dopamine receptors in the
brain.
Stimulation
of
the
dopamine
receptors
triggers
nerve
impulses
in
the
brain
that
help
to
control
body
movements.
BEFORE YOU USE PRAMEXOL
_- When you must not use it _

If you are allergic (hypersensitive)
to Pramipexole or any of the other
ingredients of this medicine (listed
in
_Ingredients). _

Pramexol is not recommended for
use
in
children
or
adolescents
under 18 years.
_ _
_Pregnancy and breastfeeding_

Do not take Pramexol if you are
pregnant, trying to get pregnant or
think you may be pregnant.

Do not take Pramexol if you are
breastfeeding. Ask your doctor or
pharmacist
for
advice
before
taking any medicine.
_- Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before
taking
Pramexol.
Tell
your
doctor if you have (had) or develop
any medical conditions or symptoms,
especially any of the following:
•
If you have kidney disease.
•
If
you
experience
hallucinations
(seeing,
hearing
or
feeling
things
that are not there).
•
If
you
have
dyskinesia
(e.g.
abnormal, uncontrolled movement of
the
limbs).
If
y

Summary of Product characteristics

1 of 4
PRAMEXOL 0.25 MG TABLET
PRAMEXOL 1 MG
TABLET
Each tablet contains:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG EQ. TO PRAMIPEXOLE
BASE 0.18 MG
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG EQ. TO PRAMIPEXOLE BASE
0.7 MG
PRODUCT DESCRIPTION:
_0.25 MG: _
White, oval, flat-faced tablet with bevelled edge, engraved PM on one
side and scored on the other
_1 MG: _
White, oval, flat-faced tablet with bevelled edge, engraved PM 1 on
one side and crossed-scored on the other
MECHANISM OF ACTION:
_PHARMACOLOGY _
Pramipexole is a dopamine agonist that binds with high selectivity and
specificity to the D2 subfamily of dopamine receptors of which it has
a preferential affinity to D3 receptors,
and has full intrinsic activity.
Pramipexole alleviates parkinsonian motor deficits by stimulation of
dopamine receptors in the striatum. Animal studies have shown that
Pramipexole inhibits dopamine synthesis,
release, and turnover._ _
_PHARMACOKINETICS _
Absorption
Pramipexole is rapidly and completely absorbed following oral
administration. The absolute bioavailability is greater than 90% and
the maximum plasma concentrations occur
between 1 and 3 hours. Concomitant administration with food did not
reduce the extent of Pramipexole absorption, but the rate of
absorption was reduced. Pramipexole shows
linear kinetics and a small inter-patient variation of plasma levels.
Distribution
In humans, the protein binding of Pramipexole is very low (< 20%) and
the volume of distribution is large (400 L). High brain tissue
concentrations were observed in the rat
(approx. 8-fold compared to plasma).
Biotransformation
Pramipexole is metabolized in man only to a small extent.
Elimination
Renal excretion of unchanged Pramipexole is the major route of
elimination. Approximately 90% of 14C-labelled dose is excreted
through the kidneys while less than 2% is found
in the feces. The total clearance of Pramipexole is approximately 500
mL/min and the renal clearance is approximately 400 mL/min. The
elimination half-life (t½) varies from 8
hours in