SIFROL ER pramipexole dihydrochloride monohydrate 1.5 mg extended-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:

Boehringer Ingelheim Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; maize starch; hypromellose; carbomer 941

Administration route:

Oral

Units in package:

30 extended-release tablets

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 to off-white, oval, biconvex tablets, one side debossed with the BI company symbol and the other side debossed with 'P3'; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-03-26

Patient Information leaflet

SIFROL
® ER
_EXTENDED-RELEASE TABLETS_
_pramipexole dihydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sifrol ER.
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 Sifrol ER
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SIFROL ER IS USED
FOR
Sifrol ER 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. Sifrol ER works
by having a similar effect as
dopamine in the brain.
_HOW SIFROL ER WORKS_
Sifrol 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 SIFROL ER HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Sifrol ER is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE SIFROL
ER
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SIFROL ER IF YOU HAVE
AN ALLERGY TO:
•
any medicine c

Summary of Product characteristics

SIFROL and SIFROL ER PI0130-12
Page 1
AUSTRALIAN PRODUCT INFORMATION – SIFROL® (PRAMIPEXOLE
DIHYDROCHLORIDE
MONOHYDRATE) TABLETS AND SIFROL
® ER (PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE)
EXTENDED-RELEASE TABLETS
1 NAME OF THE MEDICINE
pramipexole dihydrochloride monohydrate
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
SIFROL
is
available
as
immediate-release
SIFROL
tablets
and
extended-release
SIFROL ER tablets.
SIFROL tablets
SIFROL 0.125 mg tablets are flat, round, white tablets, with ‘P6’
on one face and company
symbol on the other face. Each tablet contains 0.125 mg pramipexole
dihydrochloride
monohydrate.
SIFROL 0.25 mg tablets are flat, oval, white, scored tablets, with
‘P7’ on both sides of the
score of one face, and company symbol on both sides of the score of
the other face. Each
tablet contains 0.25 mg pramipexole dihydrochloride monohydrate.
SIFROL 1 mg tablets are flat, round, white, scored tablets, with
‘P9’ on both sides of the
score of one face, and company symbol on both sides of the score of
the other face. Each
tablet contains 1 mg pramipexole dihydrochloride monohydrate.
SIFROL ER tablets
SIFROL ER 0.375 mg extended-release tablets are white to off-white,
round, biconvex,
bevel-edged tablets, with ‘P1’ on one face and company symbol on
the other face. Each
extended-release tablet contains 0.375 mg pramipexole dihydrochloride
monohydrate.
SIFROL ER 0.75 mg extended-release tablets are white to off-white,
round, biconvex, bevel-
edged tablets, with ‘P2’ on one face and company symbol on the
other face. Each extended-
release tablet contains 0.75 mg pramipexole dihydrochloride
monohydrate.
SIFROL ER 1.5 mg extended-release tablets are white to off-white,
oval, biconvex tablets,
with ‘P3’ on one face and company symbol on the other face. Each
extended-release tablet
contains 1.5 mg pramipexole dihydrochloride monohydrate.
SIFROL ER 2.25 mg extended-release tablets are white to off-white,
oval, biconvex tablets
with ‘P12’ on one face and co