PRAMIPEXOLE XR GP pramipexole dihydrochloride monohydrate 3 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pramipexole dihydrochloride monohydrate, Quantity: 3 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; calcium hydrogen phosphate; magnesium stearate; silicon dioxide

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.

Product summary:

Visual Identification: White or nearly white, cylindrical and biconvex tablets marked with 210 on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2015-06-17

Patient Information leaflet

PRAMIPEXOLE XR GP
1
PRAMIPEXOLE XR GP
_contains the active ingredient pramipexole dihydrochloride
monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRAMIPEXOLE
XR GP.
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 PRAMIPEXOLE
XR GP against the benefits it is
expected to have 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 THIS MEDICINE IS
USED FOR
PRAMIPEXOLE XR GP is 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 binds to dopamine
receptors and relays messages in the
part of the brain that controls
movement. When too little dopamine
is produced, this results in
Parkinson's disease.
_HOW IT WORKS _
PRAMIPEXOLE XR GP contains
the active ingredient pramipexole
dihydrochloride monohydrate, which
belongs to a group of medicines
known as dopamine agonists, which
bind to dopamine receptors.
PRAMIPEXOLE XR GP works by
having a similar effect as dopamine
in the brain.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
PRAMIPEXOLE XR GP HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
PRAMIPEXOLE XR GP for another
reason.
PRAMIPEXOLE XR GP is not
addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
PRAMIPEXOLE XR GP 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 THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT HAVE PRAMIPEXOLE XR
GP IF YOU HAVE AN ALLERGY TO:
•
Any medicine containing
pramipexole dihydro

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
PRAMIPEXOLE XR GP
(pramipexole dihydrochloride monohydrate) modified release tablets
1
NAME OF THE MEDICINE
Pramipexole dihydrochloride monohydrate.
2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Pramipexole dihydrochloride monohydrate modified release tablets
Pramipexole dihydrochloride monohydrate 0.375 mg modified release
tablets are white or nearly
white, cylindrical, plans and bevel tablets marked with 026 on one
side. Each modified release tablet
contains 0.375 mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 0.75 mg modified release
tablets are white or nearly
white, cylindrical and biconvex tablets marked with 052 on one side.
Each modified release tablet
contains 0.75 mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 1.5 mg modified release
tablets are white or nearly
white, cylindrical and biconvex tablets marked with 105 on one side.
Each modified release tablet
contains 1.5 mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 2.25mg modified release
tablets are white or nearly
white, cylindrical and biconvex tablets marked with 157 on one side.
Each modified release tablet
contains 2.25mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 3 mg modified release tablets
are white or nearly white,
cylindrical and biconvex tablets marked with 210 on one side. Each
modified release tablet contains
3 mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 3.75mg modified release
tablets are white or nearly
white, cylindrical and biconvex tablets marked with 262 on one side.
Each modified release tablet
contains 3.75mg pramipexole dihydrochloride monohydrate.
Pramipexole dihydrochloride monohydrate 4.5 mg modified release
tablets are white or nearly
white, cylindrical, plans and bevel tablets marked with 315 on one
side. Each modified release tablet
contains 4.5 mg pramipexole dihydrochloride mono