NEUPRO rotigotine 6 mg/24 hr transdermal patch sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rotigotine, Quantity: 13.5 mg

Available from:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

INN (International Name):

Rotigotine

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: ascorbyl palmitate; povidone; dl-alpha-tocopherol; sodium metabisulfite; methylated trimethylated silica; heptane

Administration route:

Transdermal

Units in package:

7 patches, 100 patches, 28 patches

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Parkinson's disease: Neupro is indicated as monotherapy, or in combination with levodopa, for the treatment of idiopathic Parkinson's disease from early stage to advanced disease. Restless Legs Syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Product summary:

Visual Identification: A thin, matrix-type patch that is square-shaped with rounded corners. The outside of the backing layer is tan coloured and imprinted with Neupro 6 mg/24 hr.; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-11-22

Patient Information leaflet

Neupro
®
1
NEUPRO

TRANSDERMAL PATCHES
(pronounced "NEW-pro”)
_Contains the active ingredient rotigotine_
_ _
_(pronounced "roe-TIG-oh-teen")_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Neupro.
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 Neupro
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT NEUPRO IS USED FOR
Neupro is used in the treatment of
Parkinson’s disease and Restless
Legs Syndrome (RLS)._ _
_PARKINSON’S DISEASE _
_ _
This is a disease of the nervous
system that mainly affects body
movement. The main symptoms are
shaking (tremor), muscle stiffness
and slow unsteady movement. If
untreated, Parkinson’s disease can
cause difficulty in performing daily
activities.
Parkinson’s disease is caused by
the brain not making enough of a
chemical called dopamine.
Dopamine helps the brain to control
muscle movement. When too little
dopamine is produced slowness of
movement results.
_ _
_RESTLESS LEGS SYNDROME (RLS) _
_ _
RLS is a condition characterised by
unpleasant sensations in the legs
and the irresistible urge to move in
an effort to relieve these feelings.
There is a sense of uneasiness,
restlessness, and itching often
accompanied by twitching and pain
in the legs when sitting or lying
down, especially in bed at night.
Occasionally the arms may also be
affected. RLS is thought to be due
to insufficient dopamine levels in the
brain.
Neupro belongs to a group of
medicines called non-ergot
dopamine agonists which stimulate
dopamine receptors in the brain to
increase the effects of dopamine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a do

Summary of Product characteristics

Page 1
AUSTRALIAN PRODUCT INFORMATION
NEUPRO
® (ROTIGOTINE) TRANSDERMAL PATCHES
1
NAME OF THE MEDICINE
Rotigotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neupro 1 mg: 5 cm
2
patch containing 2.25 mg rotigotine with a nominal release rate of 1
mg
rotigotine per 24 hours.
Neupro 2 mg: 10 cm
2
patch containing 4.5 mg rotigotine with a nominal release rate of 2 mg
rotigotine per 24 hours.
Neupro 3 mg: 15 cm
2
patch containing 6.75 mg rotigotine with a nominal release rate of 3
mg
rotigotine per 24 hours.
Neupro 4 mg: 20 cm
2
patch containing 9.0 mg rotigotine with a nominal release rate of 4 mg
rotigotine per 24 hours.
Neupro 6 mg: 30 cm
2
patch containing 13.5 mg rotigotine with a nominal release rate of 6
mg
rotigotine per 24 hours.
Neupro 8 mg: 40 cm
2
patch containing 18.0 mg rotigotine with a nominal release rate of 8
mg
rotigotine per 24 hours.
The active ingredient rotigotine is a white to light brownish powder.
It is very slightly soluble to
freely soluble in organic solvents, sparingly soluble in acidic
aqueous solutions and practically
insoluble in alkaline aqueous solutions.
The formulation contains sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Neupro is a thin, matrix-type transdermal patch composed of 3 layers:
1.
A flexible, tan-colored backfilm that provides structural support and
protection of the drug
loaded adhesive layer.
2.
A self-adhesive drug matrix layer.
3.
A clear protective liner which is removed prior to use.
Thin, matrix type transdermal patch that is square shaped with rounded
edges. The backing layer
comprises a polyester film, siliconized, aluminized, colour coated
with a tan coloured pigment
(titanium dioxide (E171), pigment yellow 95, pigment red 166) layer
and imprinted (pigment red 144,
pigment yellow 95, pigment black 7). The protective liner comprises a
transparent fluoropolymer
coated polyester film. The outside of the tan coloured backing layer
is imprinted with Neupro 1 mg/24
h, Neupro 2 mg/24 h, Neupro 3 mg