PRAMIPEXOLE GH pramipexole dihydrochloride 0.25 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
02-11-2017
Summary of Product characteristics
(SPC)
03-06-2015
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
pramipexole dihydrochloride monohydrate
Available from:
Generic Health Pty Ltd
INN (International Name):
pramipexole dihydrochloride monohydrate
Patient Information leaflet
Pramipexole GH CMI v2
Page 1 of 5
CONSUMER MEDICINE INFORMATION
PRAMIPEXOLE GH
pramipexole dihydrochloride monohydrate
What is in this leaflet
This leaflet answers some
common questions about
PRAMIPEXOLE GH. It does
not contain all the information
and does not take the
place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
PRAMIPEXOLE GH against
the benefits they expect it will
have for you.
Talk to your doctor or
pharmacist if you have any
concerns about taking this
medicine.
Keep this leaflet with the
medicine.
You may need to read it
again.
What PRAMIPEXOLE GH
is used for
PRAMIPEXOLE GH is used
in the treatment of
Parkinson's disease.
Parkinson's disease is a
disease of the brain that
affects body movement.
The symptoms of Parkinson's
disease are caused by a lack
of dopamine, a naturally
occurring chemical produced
by certain brain cells.
Dopamine relays messages
in the part of the brain that
controls movement. When
too little dopamine is
produced, this results in
Parkinson's disease.
PRAMIPEXOLE GH works by
having a similar effect as
dopamine in the brain.
PRAMIPEXOLE GH contains
the active ingredient
Pramipexole hydrochloride.
Pramipexole hydrochloride
belongs to a group of
medicines known as
"dopamine agonists".
Ask your doctor if you have
any questions about why
PRAMIPEXOLE GH has
been prescribed for you.
Your doctor may have
prescribed PRAMIPEXOLE
GH for another reason.
Before you take
PRAMIPEXOLE GH
When not to take it
Only use PRAMIPEXOLE
GH if it has been
prescribed for you by a
doctor.
Never give it to someone
else even if their symptoms
seem to be the same as
yours.
Do not take PRAMIPEXOLE
GH if you are allergic to
pramipexole or any of the
other ingredients listed at
the end of this leaflet.
If you are not sure if you
have these allergies, you
should raise those
concerns with your doctor.
Signs of an allergic reaction
may include itching of skin,
shortness of breath and
swelling of the tongue or
face.
You should not use
PR
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Summary of Product characteristics
1501 Pramipexole GH PI v1
Page 1 of 18
PRODUCT INFORMATION
PRAMIPEXOLE GH
_PRAMIPEXOLE HYDROCHLORIDE MONOHYDRATE_
_ _
NAME OF THE
M
ED
ICI
NE
Pramipexole hydrochloride monohydrate.
The
chemical
name
of
pramipexole
is
(_S_)-2-amino-4,5,6,7-tetrahydro-6-propylamino-
benzothiazole, [C
10
H
17
N
3
S], CAS registry number 104632-26-0, molecular weight 211.33.
Pramipexole
tablets
contain
C
10
H
17
N
3
S.2HCl.H
2
O,
molecular
weight
302.3,
CAS
registry
number
191217-81-9
for
which
the
Australian
Approved
Name
is
pramipexole
hydrochloride monohydrate.
The structural formula is:
DESC
RIPTI
ON
Pramipexole hydrochloride monohydrate is
a
white to off-white crystalline powder, freely
soluble (>20% w/v) in water.
PRAMIPEXOLE GH
tablets also contain the
following excipients:
mannitol,
pregelatinised
maize starch, silicon dioxide, povidone and magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMICS
Pramipexole is
a
dopamine agonist that binds with high selectivity and specificity to
the
dopamine D
2
subfamily receptors and has a preferential affinity to D
3
receptors. It 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.
1501 Pramipexole GH PI v1
Page 2 of 18
PHARMACOKINETICS
_ABSORPTION: _
Pramipexole
is
rapidly
absorbed, reaching peak concentrations in approximately two
hours. The absolute bioavailability of pramipexole is greater than
90%, indicating that
it is well absorbed and undergoes little presystemic metabolism. Food
does not affect
the
extent
of
pramipexole
absorption,
although
the
time
of
maximum
plasma
concentration (Tmax) is increased by about one hour when t he drug is
taken with a
meal.
_DISTRIBUTION: _
Pramipexole
is
extensively
distributed,
having
a
volume
of
distribution
of
about
500
L
(coefficient of variation [CV] = 20%). It is about 15% bound to plasma
proteins. Pramipexole
distributes into red blood cells as indicated by an
erythrocyte-to
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