SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
pramipexole dihydrochloride monohydrate, Quantity: 0.125 mg
Available from:
Alphapharm Pty Ltd
INN (International Name):
pramipexole dihydrochloride monohydrate
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: hyprolose; sodium citrate; crospovidone; magnesium stearate; mannitol; pregelatinised maize starch; colloidal anhydrous silica
Administration route:
Oral
Units in package:
10, 30, 100
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
SIMPRAL is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa. It is also indicated for the symptomatic treatment of primary Restless Legs Syndrome.
Product summary:
Visual Identification: A white to off white, round, flat-faced tablet, debossed with 'PX1' on one side and 'M' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-04-09
Patient Information leaflet
SIMPRAL
_pramipexole dihydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMPRAL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking SIMPRAL
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT SIMPRAL IS
USED FOR
SIMPRALis used to treat the
symptoms 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.
SIMPRAL works by having a similar
effect as dopamine in the brain.
_HOW SIMPRAL WORKS_
SIMPRAL contains the active
ingredient pramipexole
dihydrochloride monohydrate.
Pramipexole dihydrochloride
monohydrate belongs to a group of
medicines known as "dopamine
agonists", which bind to dopamine
receptors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
SIMPRAL is not addictive.
This medicine is available only with
a doctor's prescription.
SIMPRAL is not recommended for
use in children under 18 years of age
as its safety and effectiveness in that
age group have not been established.
BEFORE YOU TAKE
SIMPRAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SIMPRAL IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
pramipexole dihydrochloride
monohydrate (active ingredient)
or
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing o
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
SIMPRAL
_Pramipexole dihydrochloride monohydrate _
1
NAME OF THE MEDICINE
Pramipexole dihydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SIMPRAL tablet contains either 0.125 mg, 0.25 mg or 1 mg of
pramipexole dihydrochloride
monohydrate as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SIMPRAL 0.125 MG
TABLETS
:
Each 0.125 mg tablet is presented as a white to off white, round,
flat-faced tablet,
debossed with
PX1
on one side and
M
on the other side.
SIMPRAL
0.25
MG
TABLETS
:
Each 0.25 mg tablet is presented as a white to off-white, biconvex
oval shaped
tablet, debossed with
PX2
on one side and
M
on one side of breakline on other
side.
SIMPRAL
1
MG
TABLETS
:
Each 1 mg tablet is presented as a white to off white, round,
flat-faced tablet,
debossed with
M
over
PX4
on one side and breakline on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SIMPRAL is indicated for the treatment of signs and symptoms of
idiopathic Parkinson's disease. It may be
used as monotherapy or in combination with levodopa.
4.2
DOSE AND METHOD OF ADMINISTRATION
SIMPRAL tablets should be taken orally, swallowed with water. SIMPRAL
can be taken either with or without
food.
The daily dosage is administered in equally divided doses three times
per day.
PARKINSON’S DISEASE
_INITIAL TREATMENT _
Dosages should be increased gradually from a starting dose of 0.375 mg
SIMPRAL per day and then increased
every 5 to 7 days. Providing patients do not experience intolerable
side effects, the dosage should be titrated
to achieve a maximal therapeutic effect.
TABLE 1: ASCENDING DOSAGE SCHEDULE OF SIMPRAL FOR PARKINSON’S
DISEASE
WEEK
TOTAL DAILY DOSE OF
PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE
SIMPRAL TABLETS
1
0.375 mg
0.125 mg three times a day
2
0.75 mg
0.25 mg three times a day
3
1.5 mg
0.5 mg three times a day
Simpral – PRODUCT INFORMATION
2
If a further dose increase is necessary the daily dose should be
increased b
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