Pramexol 1mg Tablet

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Mevcut itibaren:

MEDISPEC (M) SDN.BHD

INN (International Adı):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Paketteki üniteler:

3 x 10 Tablets

Tarafından üretildi:

Unison Laboratories Co. Ltd.

Bilgilendirme broşürü

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PRAMEXOL 1MG TABLET
Pramipexole dihydrochloride monohydrate (1 mg) eq. to Pramipexole base
(0.7 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
Treatment of Parkinson’s disease. 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.
_ _

Pramexol is not recommended for
use in children or adolescents
under 18 years.
_ _
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_Pregnancy and breast-feeding _
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
breast-feeding. 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 you have advanced
Parkins

Ürün özellikleri

PRAMEXOL 1MG TABLET
Each tablet contains:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG EQ. TO PRAMIPEXOLE BASE
0.7 MG
♦ PRODUCT DESCRIPTION:
_1 MG: _
White, round, flat-faced tablet with bevelled edge, engraved PM1 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 the young to 12
hours in the elderly. ♦ INDICATION:
Pramexol is indicated in the treatment of signs and symptoms of
advanced idiopathic Parkinson’s disease. It may be used as
monotherapy or in combination with
lev