SIMIPEX XR pramipexole dihydrochloride monohydrate 1.5 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pramipexole dihydrochloride monohydrate, Quantity: 1.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

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

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 105 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

1
SIMIPEX XR
MODIFIED RELEASE TABLETS
Pramipexole_ _dihydrochloride monohydrate_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMIPEX XR.
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 taking SIMIPEX XR against the
benefits it is expected to 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 need to read it again.
WHAT SIMIPEX XR IS USED
FOR
SIMIPEX XR 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. SIMIPEX XR works
by having a similar effect as dopamine
in the brain.
_HOW SIMIPEX XR WORKS _
_ _
SIMIPEX XR 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 SIMIPEX XR HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
SIMIPEX XR for another reason.
SIMIPEX XR is not addictive.
This medicine is available only with a
doctor's prescription.
_USE IN CHILDREN _
_ _
SIMIPEX XR 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 SIMIPEX
XR
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE SIMIPEX XR IF YOU ARE
ALLERGIC TO:
•
pramipexole dihydrochloride
monohydrate or
•
any of the other ingredients in
SIMIPEX XR list

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SIMIPEX XR (PRAMIPEXOLE
DIHYDROCHLORIDE MONOHYDRATE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Pramipexole dihydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMIPEX XR modified release tablets come in 7 strengths containing
either 0.375mg, 0.75mg, 1.5mg,
2.25mg, 3mg, 3.75mg, or 4.5mg of pramipexole dihydrochloride
monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SIMIPEX XR 0.375mg modified release tablets are white or nearly white,
cylindrical, plans and bevel
tablets marked with 026 on one side.
SIMIPEX XR 0.75mg
modified release
tablets
are white or nearly white, cylindrical and biconvex
tablets marked with 052 on one side.
SIMIPEX XR 1.5mg modified release tablets are white or nearly white,
cylindrical and biconvex tablets
marked with 105 on one side.
SIMIPEX XR 2.25mg modified release tablets are
white
or
nearly white,
cylindrical and biconvex
tablets marked with 157 on one side.
SIMIPEX XR 3mg modified release tablets are white or nearly white,
cylindrical and biconvex tablets
marked with 210 on one side.
SIMIPEX XR 3.75mg modified release tablets are
white
or
nearly white,
cylindrical and biconvex
tablets marked with 262 on one side.
SIMIPEX XR 4.5mg modified release tablets are white or nearly white,
cylindrical, plans and bevel
tablets marked with 315 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Modified-release pramipexole tablets should be taken once daily at
about the same time each day.
Modified-release pramipexole tablets should be swallowed whole with
water and must not be
chewed, divided or
crushed.
Modified-release pramipexole tablets may be taken with or without
food.
PARKINSON’S DISEASE
_Initial treatment: _
_ _Dosages should be