PRAMIPEXOLE AN pramipexole dihydrochloride monohydrate 1 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

pramipexole dihydrochloride monohydrate

Inapatikana kutoka:

Southern Cross Pharma Pty Ltd

INN (Jina la Kimataifa):

pramipexole dihydrochloride monohydrate

Idhini hali ya:

Registered

Taarifa za kipeperushi

________________________________________________________________________________
C: Products/Pramipexole AN/CMI 14Feb14
Page
1 of 4
PRAMIPEXOLE AN
_Pramipexole hydrochloride _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
1.
WHAT PRAMIPEXOLE AN IS
USED FOR
2. BEFORE YOU TAKE PRAMIPEXOLE
AN
a)
When you must not take
PRAMIPEXOLE AN
b)
Before you start to take
PRAMIPEXOLE AN
c)
Pregnancy
d)
Breastfeeding
e)
Children
3. TAKING PRAMIPEXOLE AN
a)
How to take PRAMIPEXOLE
AN
b)
If you forget to take a dose
c)
If you have taken too much
PRAMIPEXOLE AN
(overdose)
4. WHILE YOU ARE TAKING
PRAMIPEXOLE AN
a)
Things you must do
b)
Things to be careful of 5. SIDE EFFECTS
6. AFTER TAKING PRAMIPEXOLE AN
a)
Storage
b)
Disposal
7. PRODUCT DESCRIPTION
a)
What is PRAMIPEXOLE AN
b)
Ingredients
c)
Manufacturer
This leaflet answers some common
questions about PRAMIPEXOLE AN.
It does not contain all available
information, nor does it take the place
of talking to your doctor or pharmacist.
KEEP THIS INFORMATION WITH YOUR
PRAMIPEXOLE AN.
You may need to read it again later.
TO FIND OUT MORE ABOUT
PRAMIPEXOLE AN
YOU SHOULD ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT PRAMIPEXOLE AN OR IF YOU
HAVE ANY TROUBLE BEFORE, DURING OR
AFTER USING PRAMIPEXOLE AN.
1. What PRAMIPEXOLE
AN is used for
PRAMIPEXOLE AN 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
AN works by having a similar effect as
dopamine in the brain.
PRAMIPEXOLE AN 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 AN HAS BEEN
PRESCRI

Tabia za bidhaa

PRODUCT INFORMATION
PRAMIPEXOLE AN TABLETS
NAME OF THE MEDICINE
PROPRIETARY NAME:
PRAMIPEXOLE AN Tablets
NON PROPRIETARY NAME:
Pramipexole hydrochloride monohydrate tablets
PRAMIPEXOLE HYDROCHLORIDE MONOHYDRATE.
Chemical
name:
(6
_S_
)-6-
_N_
-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
dihydrochloride monohydrate
The chemical structure of pramipexole hydrochloride monohydrate is:
Molecular formula: C
10
H
19
Cl
2
N
3
S,2HCl.H
2
O. MW: 302.3. CAS: 191217-81-9.
DESCRIPTION
Pramipexole hydrochloride monohydrate is a white to off white
crystalline powder.
Freely soluble in water, soluble in methanol, sparingly soluble to
slightly soluble in
ethanol (96%) and practically insoluble in methylene chloride.
_ACTIVE _
Pramipexole hydrochloride monohydrate
_ _
_EXCIPIENTS _
_ _
Mannitol,
pregelatinised
maize
starch,
microcrystalline
cellulose,
povidone, purified talc and magnesium stearate.
PHARMACOLOGY
_PHARMACODYNAMICS _
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
hydrochloride
alleviates
Parkinsonian
motor
deficits
by
stimulation of dopamine receptors in the striatum. Animal studies have
shown that
pramipexole inhibits dopamine synthesis, release and turnover.
C:Products/Pramipexole AN/PI 9/04/14
Page 1 of 20
In human volunteers a dose dependent decrease in prolactin was
observed.
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 the drug is
taken with a
meal.
_DISTRIBUTION_
Pramipexole is extensively distributed, having a volume of
distribution of about 500 L
(coefficient of variation (CV) = 2