Neupro 2mg24hours transdermal patches

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Rotigotine

Sẵn có từ:

UCB Pharma Ltd

Mã ATC:

N04BC09

INN (Tên quốc tế):

Rotigotine

Liều dùng:

2mg/24hour

Dạng dược phẩm:

Transdermal patch

Tuyến hành chính:

Transdermal

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 04090100; GTIN: 5015366000651

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUPRO 2 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.

RESTLESS LEGS SYNDROME (RLS)
– this can be associated with discomfort in your legs or arms,
urge to move around, sleep disturbance and feeling tired or sleepy
during the day. These
symptoms are either reduced or their duration is shortened with Neupro
treatment.
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 underg

Đặc tính sản phẩm

OBJECT 1
NEUPRO 2 MG/24 H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 04-Dec-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Neupro 2 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10
cm
2
contains 4.5 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. The outside of the
backing layer is tan-coloured and imprinted with 'Neupro 2 mg/24 h'.
4. Clinical particulars
4.1 Therapeutic indications
Restless Legs Syndrome
Neupro is indicated for the symptomatic treatment of moderate to
severe idiopathic Restless Legs
Syndrome (RLS) in adults.
Parkinson's disease
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.
_Restless Legs Syndrome_
A single daily dose should be initiated at 1 mg/24 h. Depending on the
individual patient response, the
dose may be increased in weekly increments of 1 mg/24 h to a maximum
dose of 3 mg/24 h. The need for
treatment continuation should be reconsidered every 6 months.
_Parkinson's disease_
_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 may be an effective dose in some patients. For most patients
an effective dose is reached
within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively.
The maximum dose is 8 mg/24 h.