APO-PRAMIPEXOLE ER pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pramipexole dihydrochloride monohydrate, Quantity: 0.375 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: calcium hydrogen phosphate; hypromellose; 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, plans and bevel tablets marked with 026 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:

Licence status A

Authorization date:

2015-06-17

Patient Information leaflet

APO-PRAMIPEXOLE
ER
_MODIFIED RELEASE TABLETS_
_Pramipexole dihydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about pramipexole. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Pramipexole is used to treat
symptoms of Parkinson's disease.
It belongs to a group of medicines
known as dopamine agonists.
_HOW IT WORKS_
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. Pramipexole
works by having a similar effect as
dopamine in the brain.
Pramipexole ER contains the active
ingredient pramipexole
dihydrochloride monohydrate. It
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 this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
pramipexole dihydrochloride
monohydrate (the active
•
ingredient) or
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-PRAMIPEXOLE ER
(PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) MODIFIED
RELEASE TABLET
1
NAME OF THE MEDICINE
Pramipexole Dihydrochloride Monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
APO-Pramipexole
ER
modified
release
tablet
contains
pramipexole
dihydrochloride
monohydrate, as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.375 MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical, plans and bevel tablets marked
with 026 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical and biconvex tablets marked with
052 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical and biconvex tablets marked with
105 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 2.25 MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical and biconvex tablets marked with
157 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 3 MG MODIFIED RELEASE TABLETS:
White or nearly white, cylindrical and biconvex tablets marked with
210 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 3.75MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical and biconvex tablets marked with
262 on one side.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 4.5 MG MODIFIED RELEASE
TABLETS
White or nearly white, cylindrical, plans and bevel tablets marked
with 315 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Modified-release pramipexole tablets are indicated for:
•
The treatment of signs and symptoms of idiopathic Parkinson’s
disease. It may be used as
monotherapy or in combination with levodopa.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Pramipexole
ER
modified
release
tablets
are
for
oral
administration.
Modified-release
pramipexole tablets should be taken once daily at about the same time
each day. Modified-release
pramipexole tablets sh