Leganto

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

rotigotine

Saatavilla:

UCB Pharma S.A.  

ATC-koodi:

N04BC09

INN (Kansainvälinen yleisnimi):

rotigotine

Terapeuttinen ryhmä:

Anti-Parkinson drugs

Terapeuttinen alue:

Restless Legs Syndrome; Parkinson Disease

Käyttöaiheet:

Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto 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).

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2011-06-16

Pakkausseloste

125
B. PACKAGE LEAFLET
Medicinal product no longer authorised
126
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEGANTO 1 MG/24 H TRANSDERMAL PATCH
LEGANTO 3 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 or 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Leganto is and what it is used for
2.
What you need to know before you use Leganto
3.
How to use Leganto
4.
Possible side effects
5.
How to store Leganto
6.
Contents of the pack and other information
1.
WHAT LEGANTO IS AND WHAT IT IS USED FOR
WHAT LEGANTO IS
Leganto 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 LEGANTO IS USED FOR
Leganto is used in adults to treat the signs and symptoms of:

RESTLESS LEGS SYNDROME (RLS) – this can be associated with
discomfort in your legs or arms,
urges to move around, sleep disturbance and feeling tired or sleepy
during the day. These
symptoms are either reduced or their duration is shortened with
Leganto treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LEGANTO
DO NOT USE LEGANTO 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 Leganto patch off just

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Leganto 1 mg/24 h transdermal patch
Leganto 3 mg/24 h transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Leganto 1 mg/24 h transdermal patch
Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5
cm
2
contains 2.25 mg of
rotigotine.
Leganto 3 mg/24 h transdermal patch
Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15
cm
2
contains 6.75 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.
Leganto 1 mg/24 h transdermal patch
The outside of the backing layer is tan-coloured and imprinted with
‘Leganto 1 mg/24 h’.
Leganto 3 mg/24 h transdermal patch
The outside of the backing layer is tan-coloured and imprinted with
‘Leganto 3 mg/24 h’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Leganto is indicated for the symptomatic treatment of moderate to
severe idiopathic Restless Legs
Syndrome (RLS) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose recommendations made are in nominal dose.
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.
Leganto is applied once a day. The patch should be applied at
approximately the same time every day.
The patch remains on the skin for 24 hours and will then be replaced
by a new one at a different site
of application.
If the patient forgets to apply the patch at the usual time of the day
or if the patch becomes detached,
another patch should be applied for the remainder of the day.
Medicinal product no longer authorised
3
_Treatment discontinuation _
Leganto should be discontinued gradually. The daily dose should be
reduced in steps of 1 mg/24 h