RAMIPEX 0.125mg Tablet

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Доступна з:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Одиниць в упаковці:

30 Tablets; 100 Tablets

Виробник:

Torrent Pharmaceuticals Ltd. - Indrad Plant

інформаційний буклет

RAMIPEX TABLETS
_ _
Pramipexole dihydrochloride monohydrate (0.125mg, 0.25mg)
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is RAMIPEX
used for
2.
How RAMIPEX works
3.
Before you use RAMIPEX
4.
How to use RAMIPEX
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
RAMIPEX
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT RAMIPEX
IS USED FOR
RAMIPEX is used as:
a.
Treatment of Parkinson’s disease.
It
can
be
used
alone
or
in
combination
with
levodopa
(another medicine for Parkinson’s
disease).
b.
Treatment
of
idiopathic
restless
legs
syndrome
(a
common
condition
of
the
nervous
system
that
causes
an
overwhelming,
irresistible urge to move the legs).
HOW RAMIPEX WORKS
RAMIPEX
contains
the
active
substance pramipexole and belongs to a
group of medicines known as dopamine
agonists,
which
stimulate
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 RAMIPEX
-
_When you must not use it _
Do
not
take
RAMIPEX
if
you
are
allergic to pramipexole or to any of the
other ingredients of this medicine
RAMIPEX is not recommended for use
in
children
or
adolescent
under
18
years.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
RAMIPEX
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do
not
take
RAMIPEX
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
Talk
to
your
doctor
before
taking
RAMIPEX.
Tell
your
doctor
if
you
have
(had)
or
develop
any
medical
conditions or symptoms, especially any
of the following:
▪
Kidney disease
▪
Hallucinations (seeing, hearing or
feeling things that are not there).
Most hallucinations are visual.
▪
Dyskinesia
(e.g.
abnormal,
uncontrolled
movements
of
the
limbs).
If
you
have
advanced
Parkinson’s
disease
and
are
also
taking
levodopa,
you
might
develop
dyskinesia
during
the
uptitrat

Характеристики продукта

PROPOSED PRESCRIBING INFORMATION
FOR THE USE OF A REGISTERED MEDICINAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
RAMIPEX 0.125/ RAMIPEX 0.25
(PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE TABLETS 0.125 MG/0.25 MG)
COMPOSITION
RAMIPEX 0.125
Each uncoated tablet contains:
Pramipexole Dihydrochloride Monohydrate Ph.Eur
0.125 mg equivalent to Pramipexole ..............0.088 mg
Mannitol 25……….................................... 35.375mg
Maize starch …………………………….... 10mg
Silica colloidal anhydrous ………………. 0.5 mg
Pregelatinized starch ……………………. 2.5mg
Povidone K-30 ………………………… 0.5mg
Magnesium Stearate …………………….. 1.0mg
Purified water …………………………….. q.s.
RAMIPEX 0.25
Each uncoated tablet contains:
Pramipexole Dihydrochloride Monohydrate Ph.Eur
0.25 mg equivalent to Pramipexole ..............0.18 mg
Mannitol 25……….................................... 70.750 mg
Maize starch ………………………………. 20mg
Silica colloidal anhydrous ………………. 1.0 mg
Pregelatinized starch ……………………. 5.0mg
Povidone K-30 ………………………… 1.0mg
Magnesium Stearate …………………….. 2.0mg
Purified water …………………………….. q.s.
PHARMACODYNAMICS
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists,
ATC code: N04BC05.
Pramipexole is a dopamine-agonist that binds with high selectivity and
specificity to the dopamine D2-
subfamily
receptors
and
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.
Pramipexole protect dopamine neurons from degeneration in response to
ischaemia or metamphetamine
neurotoxicity.
The precise mechanism of action of pramipexole as a treatment for
restless leg syndrome (RLS) is not
known. Although the pathophysiology of RLS is largely unknown,
neuropharmacological evidence suggests
primary dopaminer