Neupro 4mg24hours transdermal patches

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Rotigotine

Commercializzato da:

UCB Pharma Ltd

Codice ATC:

N04BC09

INN (Nome Internazionale):

Rotigotine

Dosaggio:

4mg/24hour

Forma farmaceutica:

Transdermal patch

Via di somministrazione:

Transdermal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04090100; GTIN: 5015366000668

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUPRO 4 MG/24 H TRANSDERMAL PATCH
NEUPRO 6 MG/24 H TRANSDERMAL PATCH
NEUPRO 8 MG/24 H TRANSDERMAL PATCH
Rotigotine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neupro is and what it is used for
2.
What you need to know before you use Neupro
3.
How to use Neupro
4.
Possible side effects
5.
How to store Neupro
6.
Contents of the pack and other information
1.
WHAT NEUPRO IS AND WHAT IT IS USED FOR
WHAT NEUPRO IS
Neupro contains the active substance rotigotine.
It belongs to a group of medicines called ‘dopamine agonists’.
Dopamine is a messenger in the brain
which is important for movement
WHAT NEUPRO IS USED FOR
Neupro is used in adults to treat the signs and symptoms of:

PARKINSON’S DISEASE
– Neupro can be used on its own or with another medicine called
levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NEUPRO
DO NOT USE NEUPRO IF:

you are
ALLERGIC
to
ROTIGOTINE
or any of the
OTHER INGREDIENTS
of this medicine (listed in
section 6)

you need to have a
MAGNETIC RESONANCE IMAGING
(MRI) scan (diagnostic pictures of the inside
of the body, created using magnetic rather than x-ray energy)

you need ‘
CARDIOVERSION
’ (specific treatment for abnormal heart beat).
You must take your Neupro patch off just before undergoing magnetic
resonance imaging (MRI) or
cardioversion to avoid skin burns because the patch contains
aluminium. You can put a new patch on
afterwards.
If any of the above apply to you, do not use Neu

Scheda tecnica

OBJECT 1
NEUPRO 4 MG/24 H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 04-Dec-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Neupro 4 mg/24 h transdermal patch
Neupro 6 mg/24 h transdermal patch
Neupro 8 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Neupro 4 mg/24 h transdermal patch
Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 20
cm
2
contains 9.0 mg of rotigotine.
Neupro 6 mg/24 h transdermal patch
Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30
cm
2
contains 13.5 mg of rotigotine.
Neupro 8 mg/24 h transdermal patch
Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40
cm
2
contains 18.0 mg of rotigotine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch.
Thin, matrix-type, square-shaped with rounded edges, consisting of
three layers.
Neupro 4 mg/24 h transdermal patch
The outside of the backing layer is tan-coloured and imprinted with
'Neupro 4 mg/24 h'.
Neupro 6 mg/24 h transdermal patch
The outside of the backing layer is tan-coloured and imprinted with
'Neupro 6 mg/24 h'.
Neupro 8 mg/24 h transdermal patch
The outside of the backing layer is tan-coloured and imprinted with
'Neupro 8 mg/24 h'.
4. Clinical particulars
4.1 Therapeutic indications
Neupro is indicated for the treatment of the signs and symptoms of
early-stage idiopathic Parkinson's
disease as monotherapy (i.e. without levodopa) or in combination with
levodopa, i.e. over the course of
the disease, through to late stages when the effect of levodopa wears
off or becomes inconsistent and
fluctuations of the therapeutic effect occur (end of dose or 'on-off'
fluctuations).
4.2 Posology and method of administration
Posology
The dose recommendations made are in nominal dose.
_Dosing in patients with early-stage Parkinson's disease:_
A single daily dose should be initiated at 2 mg/24 h and then
increased in weekly increments of 2 mg/24 h
to an effective dose up to a maximum dose of 8 mg/24 h.
4 mg/24 h m