Leganto

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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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 cm2 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 cm2 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. 
 



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Treatment discontinuation 
 
Leganto should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h 
with a dose reduction preferably every other day, until complete withdrawal of Leganto (see 
section 4.4). Following this procedure, rebound (worsening of symptoms beyond initial intensity after 
discontinuation of treatment) has not been observed. 
 
Special populations 
 
Hepatic impairment 
 
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution 
is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine 
clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be 
needed in case of worsening of the hepatic impairment.  
 
Renal impairment 
 
Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including 
those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute 
worsening of renal function (see section 5.2). 
 
Paediatric population 
 
The safety and efficacy of rotigotine in children and adolescents have not yet been established. 
Currently available data are described in section 5.2 but no recommendation on a posology can be 
made. 
 
Method of administration 
 
Leganto is for transdermal use. 
 
The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, 
shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Leganto 
should not be placed on skin that is red, irritated or damaged (see section 4.4). 
 
Use and handling 
 
Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One 
half of the release liner should be removed and the sticky side should be applied and pressed firmly to 
the skin. Then, the patch is fold back and the second part of the release liner is removed. The sticky 
side of the patch should not be touched. The patch should be pressed down firmly with the palm of the 
hand for about 30 seconds, so that it sticks well. 
 
The patch should not be cut into pieces. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Magnetic resonance imaging or cardioversion (see section 4.4). 
 



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4.4 Special warnings and precautions for use 
 
Magnetic resonance imaging and cardioversion 
 
The backing layer of Leganto contains aluminium. To avoid skin burns, Leganto should be removed if 
the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. 
 
Orthostatic hypotension 
 
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in 
postural/orthostatic hypotension. These events have also been observed during treatment with 
rotigotine, but the incidence was similar to that observed in placebo-treated patients. 
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the 
general risk of orthostatic hypotension associated with dopaminergic therapy. 
 
Syncope 
 
In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed 
in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were 
excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms 
of syncope and pre-syncope. 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of 
sleep during daily activities, in some cases without awareness of any warning signs, has been reported. 
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not 
acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination 
of therapy should be carefully considered.  
 
Impulse control disorders 
 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. Dose 
reduction/tapered discontinuation should be considered if such symptoms develop. 
 
Neuroleptic malignant syndrome 
 
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal 
of dopaminergic therapy. Therefore, it is recommended to taper treatment (see section 4.2). 
 
Abnormal thinking and behaviour 
 
Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations 
including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, 
disorientation, aggressive behaviour, agitation, and delirium. 
 
Fibrotic complications 
 
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, 
pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived 
dopaminergic agents. While these complications may resolve when treatment is discontinued, 
complete resolution does not always occur. 
Although these adverse reactions are believed to be related to the ergoline structure of these 
compounds, whether other, nonergot derived dopamine agonists can cause them is unknown. 



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Neuroleptics 
 
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also 
section 4.5). 
 
Ophthalmologic monitoring 
 
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 
 
Heat application 
 
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) 
should not be applied to the area of the patch. 
 
Application site reactions 
 
Application site skin reactions may occur and are usually mild or moderate in intensity. It is 
recommended that the application site should be rotated on a daily basis (e.g. from the right side to the 
left side and from the upper body to the lower body). The same site should not be used within 14 days. 
If application site reactions occur which last for more than a few days or are persistent, if there is an 
increase in severity, or if the skin reaction spreads outside the application site, an assessment of the 
risk/benefit balance for the individual patient should be conducted. 
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be 
avoided until the skin heals, as exposure could lead to changes in the skin color. 
If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or 
pruritus) associated with the use of Leganto is observed, Leganto should be discontinued. 
 
Peripheral oedema 
 
Peripheral oedema has been observed in clinical trials conducted in patients with RLS. 
 
Augmentation 
 
Augmentation may occur. Augmentation refers to the earlier onset of symptoms in the evening (or 
even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body 
parts. In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in 
the first and second years of treatment. Doses higher than the approved dose range for RLS should be 
avoided as this may lead to higher rates of augmentation (see section 5.1). 
 
Sulphite sensitivity 
 
Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including 
anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible 
people. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as 
neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish 
the effectiveness of Leganto, and co-administration should be avoided. Because of possible additive 
effects, caution should be advised when patients are taking sedating medicinal products or other CNS 
(central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol 
in combination with rotigotine. 
 
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of 
rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa. 



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Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.  
 
Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the 
pharmacokinetics and metabolism of rotigotine in healthy volunteers. 
 
Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and 
pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).  
Interactions with other forms of hormonal contraception have not been investigated. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential, contraception in females 
 
Women of childbearing potential should use effective contraception to prevent pregnancy during 
treatment with rotigotine. 
 
Pregnancy 
 
There are no adequate data from the use of rotigotine in pregnant women. Animal studies do not 
indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice 
at materno-toxic doses (see section 5.3). The potential risk for humans is unknown. Rotigotine should 
not be used during pregnancy.  
 
Breast-feeding 
 
Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected. Studies 
in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. In the absence of 
human data, breast-feeding should be discontinued. 
 
Fertility 
 
For information on fertility studies, please see section 5.3. 
 
4.7 Effects on ability to drive and use machines 
 
Rotigotine may have major influence on the ability to drive and use machines. 
Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes 
must be informed not to drive or engage in activities (e.g. operating machines) where impaired 
alertness may put themselves or others at risk of serious injury or death until such recurrent episodes 
and somnolence have resolved (see also sections 4.4 and 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Leganto- 
and 214 placebo-treated patients, 65.5% of the patients on Leganto and 33.2% of patients on placebo 
reported at least one adverse reaction. 
 
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. 
These are usually mild or moderate in intensity and transient even if treatment is continued. 
 
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto are 
nausea, application site reactions, asthenic conditions and headache. 
 



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In trials where the application sites were rotated as reflected in the instructions provided in the SmPC 
and package leaflet, 34.2% of 748 patients using Leganto, experienced application site reactions. The 
majority of application site reactions were mild or moderate in intensity, limited to the application 
areas and resulted in discontinuation of Leganto in 7.2% of subjects. 
 
Discontinuation rate 
 
The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration. The 
percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% 
in the third year. Periodic assessment of efficacy should be performed, along with evaluation of safety, 
including augmentation. 
 
Tabulated list of adverse reactions 
 
The following table covers adverse drug reactions from the pooled studies mentioned above in patients 
with Restless Legs Syndrome and from post-marketing experience. Within the system organ classes, 
adverse reactions are listed under headings of frequency (number of patients expected to experience 
the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 

System/organ 
classes acc. to 

MedDRA 

Very common 
 

Common 
 

Uncommon 
 

Rare Not known 

Immune system 
disorders 

 Hypersensitivity, 
which may 
include 
angioedema, 
tongue oedema 
and lip oedema 

   

Psychiatric 
disorders 

 Sleep 
attacks/sudden 
onset of sleep, 
sexual desire 
disordersa (incl. 
hypersexuality, 
libido 
increased), 
insomnia, sleep 
disorder, 
abnormal 
dreams, 
impulse-control 
disordersa,d (incl. 
pathological 
gambling, 
stereotypy/ 
punding, binge 
eating/eating 
disorderb, 
compulsive 
shoppingc)  

Obsessive-
compulsive 
disorder, 
agitationd 

Aggressive 
behaviour/ 
aggressionb, 
disorientationd 

Dopamine 
dysregulation 
syndromec, 
perception 
disturbancese 
(incl. 
hallucination, 
hallucination 
visual, 
hallucination 
auditory, 
illusion), 
nightmaree, 
paranoiae, 
confusional 
statee, psychotic 
disordere, 
delusione, 
deliriume 

Nervous system 
disorders 

Headache Somnolence   Dizzinesse, 
disturbances in 
consciousness 
NECe (incl. 



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syncope, 
syncope 
vasovagal, loss 
of 
consciousness), 
dyskinesiae, 
dizziness 
posturale, 
lethargye, 
convulsione 

Eye disorders     Vision blurrede, 
visual 
impairmente, 
photopsiae 

Ear and 
labyrinth 
disorders 

    Vertigoe 

Cardiac 
disorders 

    Palpitationse, 
atrial 
fibrillatione, 
supraventricular 
tachycardiae 

Vascular 
disorders 

 Hypertension Orthostatic 
hypotension 

 Hypotensione 

Respiratory, 
thoracic and 
mediastinal 
disorders 

    Hiccupse 

Gastrointestinal 
disorders 

Nausea Vomiting, 
dyspepsia 

  Constipatione, 
dry mouthe, 
abdominal paine, 
diarrhoeac 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus   Erythemae, 
hyperhidrosise, 
pruritus 
generalisede, skin 
irritatione, 
dermatitis 
contacte, rash 
generalisede 

Reproductive 
system and 
breast disorder 

    Erectile 
dysfunctione 

General 
disorders and 
administration 
site conditions 

Application and 
instillation site 
reactionsa (incl. 
erythema, 
pruritus, 
irritation, rash, 
dermatitis, 
vesicles, pain, 
eczema, 
inflammation, 
swelling, 
discolouration, 
papules, 
exfoliation, 

Irritability, 
oedema 
peripheral 

   



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urticaria, 
hypersensitivity), 
asthenic 
conditionsa (incl. 
fatigue, asthenia, 
malaise) 

Investigations     Weight 
decreasede, 
hepatic enzyme 
increasede (incl. 
AST, ALT, 
GGT), weight 
increasede, heart 
rate increasede, 
CPK increasedd,e  

Injury, 
poisoning and 
procedural 
complications 

    Falle 

Musculoskeletal 
and connective 
tissue disorders 

    Rhabdomyolysisc 

a High Level Term 
b Observed in open-label studies 
c Observed during post-marketing 
d Observed in 2011 data pool of double-blind placebo-controlled studies 
e Observed in studies performed in patients with Parkinson’s disease 
 
Description of selected adverse reactions 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden 
sleep onset episodes. In isolated cases “sudden onset of sleep” occurred while driving and resulted in 
motor vehicle accidents (see also sections 4.4 and 4.7). 
 
Impulse control disorders 
 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see 
section 4.4). 
 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
The most likely adverse reactions would be those related to the pharmacodynamic profile of a 
dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, 
confusion, convulsions and other signs of central dopaminergic stimulation. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Management 
 
There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal 
of the patch(es) should be considered because after removal of the patch(es) the active substance input 
is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be 
monitored closely, including heart rate, heart rhythm and blood pressure.  
Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis 
would not be expected to be beneficial as rotigotine is not eliminated by dialysis. 
 
If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic 
malignant syndrome. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 
 
Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s 
disease and Restless Legs Syndrome.  
 
Mechanism of action 
 
Rotigotine is believed to elicit its beneficial effect on Parkinson’s disease by activation of the D3, D2 
and D1 receptors of the caudate-putamen in the brain. 
 
The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that 
rotigotine may exert its activity mainly via dopamine receptors. 
 
Pharmacodynamic effects 
 
Regarding the functional activity at the various receptor subtypes and their distribution in the brain, 
rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-
dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, 
but no activity on the 5HT2B receptor.  
 
Clinical efficacy 
 
The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients 
with idiopathic Restless Legs Syndrome (RLS). Efficacy was demonstrated in controlled trials in 
patients treated for up to 29 weeks. The effect was maintained over a 6 months period.  
 
The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of 
illness) were primary efficacy parameters. For both primary endpoints statistically significant 
differences have been observed for the doses 1 mg/24 h, 2 mg/24 h and 3 mg/24 h in comparison to 
placebo. After 6 months of maintenance treatment in patients with moderate to severe RLS, the 
baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for rotigotine. The 
adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001). CGI-I responder rates (much 
improved, very much improved) were 43.0% and 67.5% for placebo and rotigotine respectively 
(difference 24.5% CI 95%: 14.2%; 34.8%, p<0.0001). 
In a placebo-controlled, 7-week trial polysomnographic parameters were investigated. Rotigotine 
significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 
for placebo (p<0.0001). 
 
Augmentation 



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In two 6-month, double-blind, placebo-controlled studies, clinically relevant augmentation was 
observed in 1.5% of rotigotine-treated patients versus 0.5% of placebo treated patients. In two open-
label, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 
2.9%. None of these patients discontinued therapy because of augmentation. In a 5-year open-label 
treatment study, augmentation occurred in 11.9% of patients treated with the approved dosages for 
RLS (1-3 mg/24 h), and 5.1% were considered clinically significant. In this study, the majority of 
augmentation episodes occurred in the first and second years of treatment. Furthermore, in this study a 
higher dose of 4 mg/24 h that is unapproved in RLS was also used and led to higher rates of 
augmentation. 
 
Skin adhesion 
 
In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin 
adhesion of the improved room temperature patch formulation was compared to the cold storage 
formulation, using the 8 mg/24 h rotigotine patch. Skin adhesion was measured on 2 consecutive days 
of 24 hours patch application. The improved room temperature patch formulation showed better skin 
adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. 
>70% of the patch area adhering) compared to <83%. Comparable skin tolerability was reported for 
both formulations. The majority of erythema observed was mild and none severe. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following application, rotigotine is continuously released from the transdermal patch and absorbed 
through the skin. Steady-state concentrations are reached after one to two days of patch application 
and are maintained at a stable level by once daily application in which the patch is worn for 24 hours. 
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/24 h to 
24 mg/24 h. 
 
Approximately 45% of the active substance within the patch is released to the skin in 24 hours. The 
absolute bioavailability after transdermal application is approximately 37%. 
 
Rotating the site of patch application may result in day-to-day differences in plasma levels. 
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder 
versus thigh). However, there is no indication of a relevant impact on the clinical outcome. 
 
Distribution 
 
The in vitro binding of rotigotine to plasma proteins is approximately 92%. 
The apparent volume of distribution in humans is approximately 84 l/kg. 
 
Biotransformation 
 
Rotigotine is metabolised to a great extent. Rotigotine is metabolised by N-dealkylation as well as 
direct and secondary conjugation. In vitro results indicate that different CYP isoforms are able to 
catalyse the N-dealkylation of rotigotine. Main metabolites are sulfates and glucuronide conjugates of 
the parent compound as well as N-desalkyl-metabolites, which are biologically inactive. 
The information on metabolites is incomplete. 
 



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Elimination 
 
Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is 
excreted in faeces. 
The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall 
elimination half-life is 5 to 7 hours. The pharmacokinetic profile shows a biphasic elimination with an 
initial half-life of about 2 to 3 hours. 
 
Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is 
expected. 
 
Special patient groups 
 
Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical 
tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, 
or age is not necessary. 
 
Hepatic and renal impairment 
 
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant 
increases of rotigotine plasma levels were observed. Leganto was not investigated in patients with 
severe hepatic impairment.  
Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal 
function. However, a contribution of these metabolites to clinical effects is unlikely. 
 
Paediatric population 
 
Limited pharmacokinetic data obtained in adolescent patients with RLS (13-17 years, n=24) following 
treatment with multiple doses of 0.5 to 3mg/24h showed that systemic exposure to rotigotine was 
similar to that observed in adults. Efficacy/safety data is insufficient to establish a relation between 
exposure and response (see also paediatric information in section 4.2). 
 
5.3 Preclinical safety data 
 
In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine 
agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.  
After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat 
and monkey was evident, but was slowly cleared over the 14-day observation period. 
Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the 
maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats. The effects 
were more pronounced in female rats. Additional studies to further evaluate the specific pathology 
have not been performed. Retinal degeneration was not observed during the routine histopathological 
evaluation of the eyes in any of the toxicology studies in any species used. The relevance of these 
findings to humans is not known. 
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia. Malignant 
tumours were noted predominantly in the uterus of mid- and high-dose females. These changes are 
well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to 
man. 
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice. Rotigotine 
was not teratogenic in all three species, but was embryotoxic in rats and mice at materno-toxic doses. 
Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, 
because of the effects on prolactin levels which are particularly significant in rodents. 
 
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse 
Lymphoma Assay with metabolic activation and weaker effects without metabolic activation. This 
mutagenic effect could be attributed to a clastogenic effect of rotigotine. This effect was not confirmed 
in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test. Since it 



13 

ran more or less parallel with a decreased relative total growth of the cells, it may be related to a 
cytotoxic effect of the compound. Therefore, the relevance of the one positive in vitro mutagenicity 
test is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing layer  
 
Polyester film, siliconized, aluminized,  
colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and 
imprinted (pigment red 144, pigment yellow 95, pigment black 7). 
 
Self adhesive matrix layer  
 
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate,  
Povidone K90,  
sodium metabisulphite (E223),  
ascorbyl palmitate (E304) and  
DL-α-tocopherol (E307). 
 
Release liner  
 
Transparent fluoropolymer coated polyester film. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
30 months. 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
6.5 Nature and contents of container 
 
Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an 
aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene 
(innermost layer), aluminium, ethylene copolymer and paper. 
 
The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, 
individually sealed in sachets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precaution for disposal 
 
After use the patch still contains active substance. After removal, the used patch should be folded in 
half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and 
then discarded. Any used or unused patches should be disposed of in accordance with local 
requirements or returned to the pharmacy. 
 



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7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Leganto 1 mg/24 h transdermal patch 
EU/1/11/695/001 
EU/1/11/695/003 
EU/1/11/695/004 
EU/1/11/695/007 
 
Leganto 3 mg/24 h transdermal patch 
EU/1/11/695/019 
EU/1/11/695/021 
EU/1/11/695/022 
EU/1/11/695/025 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 June 2011 
Date of latest renewal: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


15 

1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 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 cm2 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 ‘Leganto 2 mg/24 h’. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Restless Legs Syndrome 
 
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs 
Syndrome (RLS) in adults. 
 
Parkinson’s disease 
 
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). 
 
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. 
 



16 

Dosing in patients with advanced stage Parkinson’s disease with fluctuations: 
A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 
2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 
4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is 
reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h. 
 
For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 
10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.  
 
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. 
 
Treatment discontinuation 
 
Restless Legs Syndrome 
 
Leganto should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h 
with a dose reduction preferably every other day, until complete withdrawal of Leganto (see 
section 4.4). Following this procedure, rebound (worsening of symptoms beyond initial intensity after 
discontinuation of treatment) has not been observed. 
 
Parkinson’s disease 
 
Leganto should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h 
with a dose reduction preferably every other day, until complete withdrawal of Leganto (see 
section 4.4). 
 
Special populations 
 
Hepatic impairment 
 
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution 
is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine 
clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be 
needed in case of worsening of the hepatic impairment.  
 
Renal impairment 
 
Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including 
those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute 
worsening of renal function (see section 5.2). 
 
Paediatric population 
 
The safety and efficacy of rotigotine in children and adolescents have not yet been established. 
Currently available data are described in section 5.2 but no recommendation on a posology in children 
with RLS can be made. 
There is no relevant use of Leganto in the paediatric population in Parkinson’s disease. 
 
Method of administration 
 
Leganto is for transdermal use. 
 



17 

The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, 
shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Leganto 
should not be placed on skin that is red, irritated or damaged (see section 4.4). 
 
Use and handling 
 
Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One 
half of the release liner should be removed and the sticky side should be applied and pressed firmly to 
the skin. Then, the patch is fold back and the second part of the release liner is removed. The sticky 
side of the patch should not be touched. The patch should be pressed down firmly with the palm of the 
hand for about 30 seconds, so that it sticks well. 
 
The patch should not be cut into pieces. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Magnetic resonance imaging or cardioversion (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
If a Parkinson’s disease patient is insufficiently controlled while on treatment with rotigotine 
switching to another dopamine agonist might provide additional benefit (see section 5.1) 
 
Both indications: 
 
Magnetic resonance imaging and cardioversion 
 
The backing layer of Leganto contains aluminium. To avoid skin burns, Leganto should be removed if 
the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. 
 
Orthostatic hypotension 
 
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in 
postural/orthostatic hypotension. These events have also been observed during treatment with 
rotigotine, but the incidence was similar to that observed in placebo-treated patients. 
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the 
general risk of orthostatic hypotension associated with dopaminergic therapy. 
 
Syncope 
 
In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed 
in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were 
excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms 
of syncope and pre-syncope. 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of 
sleep during daily activities, in some cases without awareness of any warning signs, has been reported. 
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not 
acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination 
of therapy should be carefully considered.  
 
Impulse control disorders 



18 

 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. Dose 
reduction/tapered discontinuation should be considered if such symptoms develop. 
 
Neuroleptic malignant syndrome 
 
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal 
of dopaminergic therapy. Therefore, it is recommended to taper treatment (see section 4.2). 
 
Abnormal thinking and behaviour 
 
Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations 
including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, 
disorientation, aggressive behaviour, agitation, and delirium. 
 
Fibrotic complications 
 
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, 
pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived 
dopaminergic agents. While these complications may resolve when treatment is discontinued, 
complete resolution does not always occur. 
Although these adverse reactions are believed to be related to the ergoline structure of these 
compounds, whether other, nonergot derived dopamine agonists can cause them is unknown. 
 
Neuroleptics 
 
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also 
section 4.5). 
 
Ophthalmologic monitoring 
 
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 
 
Heat application 
 
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) 
should not be applied to the area of the patch. 
 
Application site reactions 
 
Application site skin reactions may occur and are usually mild or moderate in intensity. It is 
recommended that the application site should be rotated on a daily basis (e.g. from the right side to the 
left side and from the upper body to the lower body). The same site should not be used within 14 days. 
If application site reactions occur which last for more than a few days or are persistent, if there is an 
increase in severity, or if the skin reaction spreads outside the application site, an assessment of the 
risk/benefit balance for the individual patient should be conducted. 
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be 
avoided until the skin heals, as exposure could lead to changes in the skin color. 
If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or 
pruritus) associated with the use of Leganto is observed, Leganto should be discontinued. 
 
Peripheral oedema 
 



19 

In clinical studies in Parkinson’s patients, the 6 month-specific rates of peripheral oedema remained at 
about 4% through the entire observation period up to 36 months. Peripheral oedema has also been 
observed in clinical trials conducted in patients with RLS. 
 
Sulphite sensitivity 
 
Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including 
anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible 
people. 
 
Observed in patients with Parkinson’s disease 
 
Dopaminergic adverse reactions 
 
The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and 
peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’s patients. 
This should be considered when prescribing rotigotine. 
 
Observed in patients with Restless Legs Syndrome 
 
Augmentation 
 
Augmentation may occur in Restless Legs Syndrome patients. Augmentation refers to the earlier onset 
of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of 
symptoms to involve other body parts. In long-term clinical studies with rotigotine, the majority of 
augmentation episodes were seen in the first and second years of treatment. Doses higher than the 
approved dose range for RLS should be avoided as this may lead to higher rates of augmentation (see 
section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as 
neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish 
the effectiveness of Leganto, and co-administration should be avoided. Because of possible additive 
effects, caution should be advised when patients are taking sedating medicinal products or other CNS 
(central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol 
in combination with rotigotine. 
 
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of 
rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa. 
 
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.  
 
Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the 
pharmacokinetics and metabolism of rotigotine in healthy volunteers. 
 
Leganto may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate 
pre-existing dyskinesia, as described with other dopamine agonists. 
 
Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and 
pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).  
Interactions with other forms of hormonal contraception have not been investigated. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential, contraception in females 
 



20 

Women of childbearing potential should use effective contraception to prevent pregnancy during 
treatment with rotigotine. 
 
Pregnancy 
 
There are no adequate data from the use of rotigotine in pregnant women. Animal studies do not 
indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice 
at materno-toxic doses (see section 5.3). The potential risk for humans is unknown. Rotigotine should 
not be used during pregnancy.  
 
Breast-feeding 
 
Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected. Studies 
in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. In the absence of 
human data, breast-feeding should be discontinued. 
 
Fertility 
 
For information on fertility studies, please see section 5.3. 
 
4.7 Effects on ability to drive and use machines 
 
Rotigotine may have major influence on the ability to drive and use machines. 
Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes 
must be informed not to drive or engage in activities (e.g. operating machines) where impaired 
alertness may put themselves or others at risk of serious injury or death until such recurrent episodes 
and somnolence have resolved (see also sections 4.4 and 4.5). 
 
4.8 Undesirable effects 
 
Restless Legs Syndrome 
 
Summary of the safety profile 
 
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Leganto- 
and 214 placebo-treated patients, 65.5% of the patients on Leganto and 33.2% of patients on placebo 
reported at least one adverse reaction. 
 
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. 
These are usually mild or moderate in intensity and transient even if treatment is continued. 
 
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto are 
nausea, application site reactions, asthenic conditions and headache. 
 
In trials where the application sites were rotated as reflected in the instructions provided in the SmPC 
and package leaflet, 34.2% of 748 patients using Leganto, experienced application site reactions. The 
majority of application site reactions were mild or moderate in intensity, limited to the application 
areas and resulted in discontinuation of Leganto in 7.2% of subjects. 
 
Discontinuation rate 
 
The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration. The 
percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% 
in the third year. Periodic assessment of efficacy should be performed, along with evaluation of safety, 
including augmentation. 
 
Tabulated list of adverse reactions 



21 

 
The following table covers adverse drug reactions from the pooled studies mentioned above in patients 
with Restless Legs Syndrome and from post-marketing experience. Within the system organ classes, 
adverse reactions are listed under headings of frequency (number of patients expected to experience 
the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 

System/organ 
classes acc. to 

MedDRA 

Very common 
 

Common 
 

Uncommon 
 

Rare Not known 

Immune system 
disorders 

 Hypersensitivity, 
which may 
include 
angioedema, 
tongue oedema 
and lip oedema 

   

Psychiatric 
disorders 

 Sleep 
attacks/sudden 
onset of sleep, 
sexual desire 
disordersa (incl. 
hypersexuality, 
libido 
increased), 
insomnia, sleep 
disorder, 
abnormal 
dreams, 
impulse-control 
disordersa,d (incl. 
pathological 
gambling, 
stereotypy/ 
punding, binge 
eating/eating 
disorderb, 
compulsive 
shoppingc)  

Obsessive-
compulsive 
disorder, 
agitationd 

Aggressive 
behaviour/ 
aggressionb, 
disorientationd  

Dopamine 
dysregulation 
syndromec, 
perception 
disturbancese 
(incl. 
hallucination, 
hallucination 
visual, 
hallucination 
auditory, 
illusion), 
nightmaree, 
paranoiae, 
confusional 
statee, psychotic 
disordere, 
delusione, 
deliriume 



22 

Nervous system 
disorders 

Headache Somnolence   Dizzinesse, 
disturbances in 
consciousness 
NECe (incl. 
syncope, 
syncope 
vasovagal, loss 
of 
consciousness), 
dyskinesiae, 
dizziness 
posturale, 
lethargye, 
convulsione 

Eye disorders     Vision blurrede, 
visual 
impairmente, 
photopsiae 

Ear and 
labyrinth 
disorders 

    Vertigoe 

Cardiac 
disorders 

    Palpitationse, 
atrial 
fibrillatione, 
supraventricular 
tachycardiae 

Vascular 
disorders 

 Hypertension Orthostatic 
hypotension 

 Hypotensione 

Respiratory, 
thoracic and 
mediastinal 
disorders 

    Hiccupse 

Gastrointestinal 
disorders 

Nausea Vomiting, 
dyspepsia 

  Constipatione, 
dry mouthe, 
abdominal paine, 
diarrhoeac 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus   Erythemae, 
hyperhidrosise, 
pruritus 
generalisede, skin 
irritatione, 
dermatitis 
contacte, rash 
generalisede 

Reproductive 
system and 
breast disorder 

    Erectile 
dysfunctione 



23 

General 
disorders and 
administration 
site conditions 

Application and 
instillation site 
reactionsa (incl. 
erythema, 
pruritus, 
irritation, rash, 
dermatitis, 
vesicles, pain, 
eczema, 
inflammation, 
swelling, 
discolouration, 
papules, 
exfoliation, 
urticaria, 
hypersensitivity), 
asthenic 
conditionsa (incl. 
fatigue, asthenia, 
malaise) 

Irritability, 
oedema 
peripheral 

   

Investigations     Weight 
decreasede, 
hepatic enzyme 
increasede (incl. 
AST, ALT, 
GGT), weight 
increasede, heart 
rate increasede, 
CPK increasedd,e  

Injury, 
poisoning and 
procedural 
complications 

    Falle 

Musculoskeletal 
and connective 
tissue disorders 

    Rhabdomyolysisc 

a High Level Term 
b Observed in open-label studies 
c Observed during post-marketing 
d Observed in 2011 data pool of double-blind placebo-controlled studies 
e Observed in studies performed in patients with Parkinson’s disease 
 
Parkinson’s disease 
 
Summary of the safety profile 
 
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Leganto- 
and 607 placebo-treated patients, 72.5% of the patients on Leganto and 58.0% of patients on placebo 
reported at least one adverse reaction. 
 
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. 
These are usually mild or moderate in intensity and transient even if treatment is continued. 
 
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto 
transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and 
headache. 
 



24 

In trials where the application sites were rotated as reflected in the instructions provided in SmPC and 
package leaflet, 35.7% of 830 patients using the Leganto transdermal patch, experienced application 
site reactions. The majority of application site reactions were mild or moderate in intensity, limited to 
the application areas and resulted in discontinuation of treatment with Leganto in only 4.3% of all 
subjects receiving Leganto. 
 
Tabulated list of adverse reactions 
 
The following table covers adverse drug reactions from the pooled studies mentioned above in patients 
with Parkinson’s disease and from post-marketing experience. Within the system organ classes, 
adverse reactions are listed under headings of frequency (number of patients expected to experience 
the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 
System/organ 
classes acc. to 

MedDRA 

Very common 
 

Common 
 

Uncommon 
 

Rare 
 

Not known 

Immune system 
disorders 

  Hypersensitivity, 
which may 
include 
angioedema, 
tongue oedema 
and lip oedema 

  

Psychiatric 
disorders 

 Perception 
disturbancesa 
(incl. 
hallucination, 
hallucination 
visual, 
hallucination 
auditory, 
illusion), 
insomnia, sleep 
disorder, 
nightmare, 
abnormal 
dreams, 
impulse-
control 
disordersa,d 
(incl. 
pathological 
gambling, 
stereotypy/ 
punding, binge 
eating/eating 
disorderb, 
compulsive 
shoppingc) 

Sleep 
attacks/sudden 
onset of sleep, 
paranoia, sexual 
desire disordersa 
(incl. 
hypersexuality, 
libido 
increased), 
confusional 
state, 
disorientationd, 
agitationd 

Psychotic 
disorder, 
obsessive-
compulsive 
disorder, 
aggressive 
behaviour/ 
aggressionb, 
delusiond, 
deliriumd 

Dopamine 
dysregulation 
syndromec 



25 

Nervous system 
disorders 

Somnolence, 
dizziness, 
headache 

Disturbances in 
consciousness 
NECa (incl. 
syncope, 
syncope 
vasovagal, loss 
of 
consciousness), 
dyskinesia, 
dizziness 
postural, 
lethargy 

 Convulsion  Dropped head 
syndromec,e 

Eye disorders 
 

  Vision blurred, 
visual 
impairment, 
photopsia 

  

Ear and 
labyrinth 
disorders 

 Vertigo    

Cardiac 
disorders 

 Palpitations Atrial fibrillation  Supraventricular 
tachycardia 

 

Vascular 
disorders 

 Orthostatic 
hypotension, 
hypertension  

Hypotension   

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Hiccups    

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Constipation, 
dry mouth, 
dyspepsia 

Abdominal pain  
 

 Diarrhoeac 

Skin and 
subcutaneous 
tissue disorders 

 Erythema, 
hyperhidrosis, 
pruritus 

Pruritus 
generalised, skin 
irritation, 
dermatitis 
contact 

Rash 
generalised 

 

Reproductive 
system and 
breast disorder 

  Erectile 
dysfunction 

  

General 
disorders and 
administration 
site conditions 

Application and 
instillation site 
reactionsa (incl. 
erythema, 
pruritus, 
irritation, rash, 
dermatitis, 
vesicles, pain, 
eczema, 
inflammation, 
swelling, 
discolouration, 
papules, 
exfoliation, 
urticaria, 
hypersensitivity) 

Oedema 
peripheral, 
asthenic 
conditionsa 
(incl. fatigue, 
asthenia, 
malaise) 

 Irritability 
 

 



26 

Investigations  Weight 
decreased 

Hepatic enzyme 
increased (incl. 
AST, ALT, 
GGT), weight 
increased, heart 
rate increased, 
CPK increasedd  

  

Injury, 
poisoning and 
procedural 
complications 

 Fall    

Musculoskeletal 
and connective 
tissue disorders 

    Rhabdomyolysisc 

a High Level Term 
b Observed in open-label studies 
c Observed during post-marketing 
d Observed in 2011 data pool of double-blind placebo-controlled studies 
e  Only observed in Parkinson’s disease patients 
 
Both indications 
 
Description of selected adverse reactions 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden 
sleep onset episodes. In isolated cases “sudden onset of sleep” occurred while driving and resulted in 
motor vehicle accidents (see also sections 4.4 and 4.7). 
 
Impulse control disorders 
 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see 
section 4.4). 
 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
The most likely adverse reactions would be those related to the pharmacodynamic profile of a 
dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, 
confusion, convulsions and other signs of central dopaminergic stimulation. 
 
Management 
 
There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal 
of the patch(es) should be considered because after removal of the patch(es) the active substance input 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


27 

is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be 
monitored closely, including heart rate, heart rhythm and blood pressure.  
Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis 
would not be expected to be beneficial as rotigotine is not eliminated by dialysis. 
 
If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic 
malignant syndrome. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 
 
Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s 
disease and Restless Legs Syndrome.  
 
Mechanism of action 
 
Rotigotine is believed to elicit its beneficial effect on Parkinson’s disease by activation of the D3, D2 
and D1 receptors of the caudate-putamen in the brain. 
 
The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that 
rotigotine may exert its activity mainly via dopamine receptors. 
 
Pharmacodynamic effects 
 
Regarding the functional activity at the various receptor subtypes and their distribution in the brain, 
rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-
dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, 
but no activity on the 5HT2B receptor.  
 
Clinical efficacy and safety 
 
Clinical studies in Restless Legs Syndrome 
 
The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients 
with idiopathic Restless Legs Syndrome (RLS). Efficacy was demonstrated in controlled trials in 
patients treated for up to 29 weeks. The effect was maintained over a 6 months period.  
 
The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of 
illness) were primary efficacy parameters. For both primary endpoints statistically significant 
differences have been observed for the doses 1 mg/24 h, 2 mg/24 h and 3 mg/24 h in comparison to 
placebo. After 6 months of maintenance treatment in patients with moderate to severe RLS, the 
baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for rotigotine. The 
adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001). CGI-I responder rates (much 
improved, very much improved) were 43.0% and 67.5% for placebo and rotigotine respectively 
(difference 24.5% CI 95%: 14.2%; 34.8%, p<0.0001). 
In a placebo-controlled, 7-week trial polysomnographic parameters were investigated. Rotigotine 
significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 
for placebo (p<0.0001). 
 
Augmentation 
 
In two 6-month, double-blind, placebo-controlled studies, clinically relevant augmentation was 
observed in 1.5% of rotigotine-treated patients versus 0.5% of placebo treated patients. In two open-



28 

label, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 
2.9%. None of these patients discontinued therapy because of augmentation. In a 5-year open-label 
treatment study, augmentation occurred in 11.9% of patients treated with the approved dosages for 
RLS (1-3 mg/24 h), and 5.1% were considered clinically significant. In this study, the majority of 
augmentation episodes occurred in the first and second years of treatment. Furthermore, in this study a 
higher dose of 4 mg/24 h that is unapproved in RLS was also used and led to higher rates of 
augmentation. 
 
Clinical studies in Parkinson’s disease 
 
The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's 
disease was evaluated in a multinational drug development program consisting of four pivotal, 
parallel, randomized, double-blind placebo controlled studies and three studies investigating specific 
aspects of Parkinson’s disease. 
 
Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in 
the treatment of the signs and symptoms of idiopathic Parkinson’s disease were conducted in patients 
who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or 
previous L-dopa treatment was ≤ 6 months. The primary outcome assessment was the score for the 
Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part 
III) of the Unified Parkinson’s Disease Rating Scale (UPDRS).  
Efficacy was determined by the subject’s response to therapy in terms of responder and absolute 
points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III). 
 
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received 
placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments 
of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group 
were maintained at their optimal dose for 6 months. 
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the 
subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 
18%; 39%, p<0.0001). With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was 
-3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was 
observed (baseline 30.0 points). The difference was 5.28 points and statistically significant 
(p<0.0001).  
 
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 
117 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks. In the 
ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 
weeks. Patients in each treatment group were maintained for 6 months. 
At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the 
subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects 
receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference 
ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%, 
CI95% 7.6%; 25.7%). The mean improvement in the UPDRS score (Parts II + III) was 6.83 points 
(baseline 33.2 points) in the rotigotine arm, 10.78 points in the ropinirole arm (baseline 32.2 points) 
and 2.33 points in the placebo arm (baseline 31.3 points). All differences between the active 
treatments and placebo were statistically significant. This study failed to demonstrate non-inferiority 
of rotigotine to ropinirole.  
 
In a subsequent open-label study (SP824), a multicenter, multinational study, the tolerability of 
overnight switching from ropinirole, pramipexole or cabergoline to rotigotine transdermal patch and 
its effect on symptoms in subjects with idiopathic Parkinson’s disease have been studied. 116 patients 
were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 
47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up 



29 

to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day. Switching to rotigotine 
was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients 
switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline. 
Improvements were seen in UPDRS Parts I - IV scores. The safety profile was unchanged from that 
observed in previous studies. 
 
In a randomized, open-label study (SP825) in patients with early-stage Parkinson’s disease, 25 
patients were randomized to rotigotine treatment and 26 to ropinirole. In both arms treatment was 
titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively. Both treatments showed 
improvements in early morning motor function and sleep. Motor symptoms (UPDRS Part III) 
improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-
group after 4 weeks of maintenance. Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-
treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients. The safety profile was 
comparable, with the exception of application site reactions. 
 
In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at 
equivalent doses were shown to have comparable efficacy. 
 
Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving 
concomitant levodopa therapy. The primary outcome assessment was the reduction in “off” time 
(hours). Efficacy was determined by the subject’s response to therapy in terms of responder and 
absolute improvement in the time spent “off”. 
 
In the double blind study SP650DB, 113 patients received rotigotine up to a maximum dose of 
8 mg/24 h, 109 patients received rotigotine up to a maximum dose of 12 mg/24 h and 119 patients 
received placebo. The patients were titrated to their optimal doses of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h. Patients in each treatment group were maintained at 
their optimal dose for 6 months. At the end of the maintenance treatment an improvement of at least 
30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, 
respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, 
CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups). With rotigotine, the 
mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm 
a reduction of 0.9 hours was observed. The differences were statistically significant (p<0.001 and 
p=0.003, respectively). 
 
In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 
100 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h to a maximum dose of 16 mg/24 h. In the pramipexole 
group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated 
further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/day. 
Patients in each treatment group were maintained for 4 months. 
At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the 
subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects 
receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole 
versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%). 
The mean reduction in the “off” time was 2.5 hours in the rotigotine arm, 2.8 hours in the pramipexole 
arm and 0.9 hours in the placebo arm. All differences between the active treatments and placebo were 
statistically significant.  
 
A further multinational double-blind study (SP889) was conducted in 287 patients with early or 
advanced stages of Parkinson’s disease who had unsatisfactory early morning motor symptom control. 
81.5% of these patients were on concomitant levodopa therapy. 190 patients received rotigotine, and 
97 placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 16 mg/24 h over 8 weeks, 
followed by a maintenance period of 4 weeks. Early morning motor function, assessed by UPDRS part 
III, and nocturnal sleep disturbances, measured by the modified Parkinson’s Disease Sleep Scale 



30 

(PDSS-2), were co-primary outcome measures. At the end of maintenance, the mean UPDRS part III 
score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the 
placebo-group (baseline 32.0). Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, 
baseline 19.3) and 1.9 points (placebo, baseline 20.5). Treatment differences for the coprimary 
variables were statistically significant (p=0.0002 and p<0.0001). 
 
Skin adhesion 
 
In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin 
adhesion of the improved room temperature patch formulation was compared to the cold storage 
formulation, using the 8 mg/24 h rotigotine patch. Skin adhesion was measured on 2 consecutive days 
of 24 hours patch application. The improved room temperature patch formulation showed better skin 
adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. 
>70% of the patch area adhering) compared to <83%. Comparable skin tolerability was reported for 
both formulations. The majority of erythema observed was mild and none severe. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following application, rotigotine is continuously released from the transdermal patch and absorbed 
through the skin. Steady-state concentrations are reached after one to two days of patch application 
and are maintained at a stable level by once daily application in which the patch is worn for 24 hours. 
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/24 h to 
24 mg/24 h. 
 
Approximately 45% of the active substance within the patch is released to the skin in 24 hours. The 
absolute bioavailability after transdermal application is approximately 37%. 
 
Rotating the site of patch application may result in day-to-day differences in plasma levels. 
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder 
versus thigh). However, there is no indication of a relevant impact on the clinical outcome. 
 
Distribution 
 
The in vitro binding of rotigotine to plasma proteins is approximately 92%. 
The apparent volume of distribution in humans is approximately 84 l/kg. 
 
Biotransformation 
 
Rotigotine is metabolised to a great extent. Rotigotine is metabolised by N-dealkylation as well as 
direct and secondary conjugation. In vitro results indicate that different CYP isoforms are able to 
catalyse the N-dealkylation of rotigotine. Main metabolites are sulfates and glucuronide conjugates of 
the parent compound as well as N-desalkyl-metabolites, which are biologically inactive. 
The information on metabolites is incomplete. 
 
Elimination 
 
Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is 
excreted in faeces. 
The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall 
elimination half-life is 5 to 7 hours. The pharmacokinetic profile shows a biphasic elimination with an 
initial half-life of about 2 to 3 hours. 
 
Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is 
expected. 
 



31 

Special patient groups 
 
Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical 
tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, 
or age is not necessary. 
 
Hepatic and renal impairment 
 
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant 
increases of rotigotine plasma levels were observed. Leganto was not investigated in patients with 
severe hepatic impairment.  
Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal 
function. However, a contribution of these metabolites to clinical effects is unlikely. 
 
Paediatric population 
 
Limited pharmacokinetic data obtained in adolescent patients with RLS (13-17 years, n=24) following 
treatment with multiple doses of 0.5 to 3mg/24h showed that systemic exposure to rotigotine was 
similar to that observed in adults. Efficacy/safety data is insufficient to establish a relation between 
exposure and response (see also paediatric information in section 4.2). 
 
5.3 Preclinical safety data 
 
In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine 
agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.  
After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat 
and monkey was evident, but was slowly cleared over the 14-day observation period. 
Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the 
maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats. The effects 
were more pronounced in female rats. Additional studies to further evaluate the specific pathology 
have not been performed. Retinal degeneration was not observed during the routine histopathological 
evaluation of the eyes in any of the toxicology studies in any species used. The relevance of these 
findings to humans is not known. 
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia. Malignant 
tumours were noted predominantly in the uterus of mid- and high-dose females. These changes are 
well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to 
man. 
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice. Rotigotine 
was not teratogenic in all three species, but was embryotoxic in rats and mice at materno-toxic doses. 
Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, 
because of the effects on prolactin levels which are particularly significant in rodents. 
 
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse 
Lymphoma Assay with metabolic activation and weaker effects without metabolic activation. This 
mutagenic effect could be attributed to a clastogenic effect of rotigotine. This effect was not confirmed 
in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test. Since it 
ran more or less parallel with a decreased relative total growth of the cells, it may be related to a 
cytotoxic effect of the compound. Therefore, the relevance of the one positive in vitro mutagenicity 
test is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing layer  
 



32 

Polyester film, siliconized, aluminized,  
colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and 
imprinted (pigment red 144, pigment yellow 95, pigment black 7). 
 
Self adhesive matrix layer  
 
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate,  
Povidone K90,  
sodium metabisulphite (E223),  
ascorbyl palmitate (E304) and  
DL-α-tocopherol (E307). 
 
Release liner  
 
Transparent fluoropolymer coated polyester film. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
30 months. 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
6.5 Nature and contents of container 
 
Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an 
aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene 
(innermost layer), aluminium, ethylene copolymer and paper. 
 
The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, 
individually sealed in sachets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precaution for disposal 
 
After use the patch still contains active substance. After removal, the used patch should be folded in 
half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and 
then discarded. Any used or unused patches should be disposed of in accordance with local 
requirements or returned to the pharmacy. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 



33 

 
EU/1/11/695/010 
EU/1/11/695/012 
EU/1/11/695/013 
EU/1/11/695/016 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 June 2011 
Date of latest renewal: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


34 

1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 4 mg/24 h transdermal patch 
Leganto 6 mg/24 h transdermal patch 
Leganto 8 mg/24 h transdermal patch 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Leganto 4 mg/24 h transdermal patch 
Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 20 cm2 contains 9.0 mg of 
rotigotine. 
 
Leganto 6 mg/24 h transdermal patch 
Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30 cm2 contains 13.5 mg of 
rotigotine. 
 
Leganto 8 mg/24 h transdermal patch 
Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 cm2 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.  
 
Leganto 4 mg/24 h transdermal patch 
The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 4 mg/24 h’. 
 
Leganto 6 mg/24 h transdermal patch 
The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 6 mg/24 h’. 
 
Leganto 8 mg/24 h transdermal patch 
The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 8 mg/24 h’. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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). 
 
4.2 Posology and method of administration 
 
Posology 
 
The dose recommendations made are in nominal dose. 
 



35 

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. 
 
Dosing in patients with advanced stage Parkinson’s disease with fluctuations: 
A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 
2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 
4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is 
reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h. 
 
For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 
10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.  
 
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. 
 
Treatment discontinuation 
 
Leganto should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h 
with a dose reduction preferably every other day, until complete withdrawal of Leganto (see 
section 4.4). 
 
Special populations 
 
Hepatic impairment 
 
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution 
is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine 
clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be 
needed in case of worsening of the hepatic impairment.  
 
Renal impairment 
 
Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including 
those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute 
worsening of renal function (see section 5.2). 
 
Paediatric population 
 
There is no relevant use of Leganto in the paediatric population in Parkinson’s disease. 
 
 
Method of administration 
 
Leganto is for transdermal use. 
 
The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, 
shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Leganto 
should not be placed on skin that is red, irritated or damaged (see section 4.4). 
 



36 

Use and handling 
 
Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One 
half of the release liner should be removed and the sticky side should be applied and pressed firmly to 
the skin. Then, the patch is fold back and the second part of the release liner is removed. The sticky 
side of the patch should not be touched. The patch should be pressed down firmly with the palm of the 
hand for about 30 seconds, so that it sticks well. 
 
The patch should not be cut into pieces. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Magnetic resonance imaging or cardioversion (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
If a Parkinson’s disease patient is insufficiently controlled while on treatment with rotigotine 
switching to another dopamine agonist might provide additional benefit (see section 5.1) 
 
Magnetic resonance imaging and cardioversion 
 
The backing layer of Leganto contains aluminium. To avoid skin burns, Leganto should be removed if 
the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. 
 
Orthostatic hypotension 
 
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in 
postural/orthostatic hypotension. These events have also been observed during treatment with 
rotigotine, but the incidence was similar to that observed in placebo-treated patients. 
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the 
general risk of orthostatic hypotension associated with dopaminergic therapy. 
 
Syncope 
 
In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed 
in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were 
excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms 
of syncope and pre-syncope. 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of 
sleep during daily activities, in some cases without awareness of any warning signs, has been reported. 
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not 
acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination 
of therapy should be carefully considered.  
 
Impulse control disorders 
 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. Dose 
reduction/tapered discontinuation should be considered if such symptoms develop. 
 
Neuroleptic malignant syndrome 



37 

 
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal 
of dopaminergic therapy. Therefore, it is recommended to taper treatment (see section 4.2). 
 
Abnormal thinking and behaviour 
 
Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations 
including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, 
disorientation, aggressive behaviour, agitation, and delirium. 
 
Fibrotic complications 
 
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, 
pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived 
dopaminergic agents. While these complications may resolve when treatment is discontinued, 
complete resolution does not always occur. 
Although these adverse reactions are believed to be related to the ergoline structure of these 
compounds, whether other, nonergot derived dopamine agonists can cause them is unknown. 
 
Neuroleptics 
 
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also 
section 4.5). 
 
Ophthalmologic monitoring 
 
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 
 
Heat application 
 
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) 
should not be applied to the area of the patch. 
 
Application site reactions 
 
Application site skin reactions may occur and are usually mild or moderate in intensity. It is 
recommended that the application site should be rotated on a daily basis (e.g. from the right side to the 
left side and from the upper body to the lower body). The same site should not be used within 14 days. 
If application site reactions occur which last for more than a few days or are persistent, if there is an 
increase in severity, or if the skin reaction spreads outside the application site, an assessment of the 
risk/benefit balance for the individual patient should be conducted. 
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be 
avoided until the skin heals, as exposure could lead to changes in the skin color. 
If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or 
pruritus) associated with the use of Leganto is observed, Leganto should be discontinued. 
 
Peripheral oedema 
 
In clinical studies in Parkinson’s patients, the 6 month-specific rates of peripheral oedema remained at 
about 4% through the entire observation period up to 36 months. 
 
Dopaminergic adverse reactions 
 
The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and 
peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’s patients. 
This should be considered when prescribing rotigotine. 
 



38 

Sulphite sensitivity 
 
Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including 
anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible 
people. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as 
neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish 
the effectiveness of Leganto, and co-administration should be avoided. Because of possible additive 
effects, caution should be advised when patients are taking sedating medicinal products or other CNS 
(central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol 
in combination with rotigotine. 
 
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of 
rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa. 
 
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.  
 
Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the 
pharmacokinetics and metabolism of rotigotine in healthy volunteers. 
 
Leganto may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate 
pre-existing dyskinesia, as described with other dopamine agonists. 
 
Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and 
pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).  
Interactions with other forms of hormonal contraception have not been investigated. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential, contraception in females 
 
Women of childbearing potential should use effective contraception to prevent pregnancy during 
treatment with rotigotine. 
 
Pregnancy 
 
There are no adequate data from the use of rotigotine in pregnant women. Animal studies do not 
indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice 
at materno-toxic doses (see section 5.3). The potential risk for humans is unknown. Rotigotine should 
not be used during pregnancy.  
 
Breast-feeding 
 
Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected. Studies 
in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. In the absence of 
human data, breast-feeding should be discontinued. 
 
Fertility 
 
For information on fertility studies, please see section 5.3. 
 



39 

4.7 Effects on ability to drive and use machines 
 
Rotigotine may have major influence on the ability to drive and use machines. 
Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes 
must be informed not to drive or engage in activities (e.g. operating machines) where impaired 
alertness may put themselves or others at risk of serious injury or death until such recurrent episodes 
and somnolence have resolved (see also sections 4.4 and 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Leganto- 
and 607 placebo-treated patients, 72.5% of the patients on Leganto and 58.0% of patients on placebo 
reported at least one adverse reaction. 
 
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. 
These are usually mild or moderate in intensity and transient even if treatment is continued. 
 
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto 
transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and 
headache. 
 
In trials where the application sites were rotated as reflected in the instructions provided in SmPC and 
package leaflet, 35.7% of 830 patients using the Leganto transdermal patch, experienced application 
site reactions. The majority of application site reactions were mild or moderate in intensity, limited to 
the application areas and resulted in discontinuation of treatment with Leganto in only 4.3% of all 
subjects receiving Leganto. 
 
Tabulated list of adverse reactions 
 
The following table covers adverse drug reactions from the pooled studies mentioned above in patients 
with Parkinson’s disease and from post-marketing experience. Within the system organ classes, 
adverse reactions are listed under headings of frequency (number of patients expected to experience 
the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 
System/organ 
classes acc. to 

MedDRA 

Very common 
 

Common 
 

Uncommon 
 

Rare 
 

Not known 

Immune system 
disorders 

  Hypersensitivity, 
which may 
include 
angioedema, 
tongue oedema 
and lip oedema 

  



40 

Psychiatric 
disorders 

 Perception 
disturbancesa 
(incl. 
hallucination, 
hallucination 
visual, 
hallucination 
auditory, 
illusion), 
insomnia, sleep 
disorder, 
nightmare, 
abnormal 
dreams, 
impulse-
control 
disordersa,d 
(incl. 
pathological 
gambling, 
stereotypy/ 
punding, binge 
eating/eating 
disorderb, 
compulsive 
shoppingc) 

Sleep 
attacks/sudden 
onset of sleep, 
paranoia, sexual 
desire disordersa 
(incl. 
hypersexuality, 
libido 
increased), 
confusional 
state, 
disorientationd, 
agitationd 

Psychotic 
disorder, 
obsessive-
compulsive 
disorder, 
aggressive 
behaviour/ 
aggressionb, 
delusiond, 
deliriumd 

Dopamine 
dysregulation 
syndromec 

Nervous system 
disorders 

Somnolence, 
dizziness, 
headache 

Disturbances in 
consciousness 
NECa (incl. 
syncope, 
syncope 
vasovagal, loss 
of 
consciousness), 
dyskinesia, 
dizziness 
postural, 
lethargy 

 Convulsion  Dropped head 
syndromec 

Eye disorders 
 

  Vision blurred, 
visual 
impairment, 
photopsia 

  

Ear and 
labyrinth 
disorders 

 Vertigo    

Cardiac 
disorders 

 Palpitations Atrial fibrillation  Supraventricular 
tachycardia 

 

Vascular 
disorders 

 Orthostatic 
hypotension, 
hypertension  

Hypotension   

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Hiccups    

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Constipation, 
dry mouth, 
dyspepsia 

Abdominal pain  
 

 Diarrhoeac 



41 

Skin and 
subcutaneous 
tissue disorders 

 Erythema, 
hyperhidrosis, 
pruritus 

Pruritus 
generalised, skin 
irritation, 
dermatitis 
contact 

Rash 
generalised 

 

Reproductive 
system and 
breast disorder 

  Erectile 
dysfunction 

  

General 
disorders and 
administration 
site conditions 

Application and 
instillation site 
reactionsa (incl. 
erythema, 
pruritus, 
irritation, rash, 
dermatitis, 
vesicles, pain, 
eczema, 
inflammation, 
swelling, 
discolouration, 
papules, 
exfoliation, 
urticaria, 
hypersensitivity) 

Oedema 
peripheral, 
asthenic 
conditionsa 
(incl. fatigue, 
asthenia, 
malaise) 

 Irritability 
 

 

Investigations  Weight 
decreased 

Hepatic enzyme 
increased (incl. 
AST, ALT, 
GGT), weight 
increased, heart 
rate increased, 
CPK increasedd  

  

Injury, 
poisoning and 
procedural 
complications 

 Fall    

Musculoskeletal 
and connective 
tissue disorders 

    Rhabdomyolysisc 

a High Level Term 
b Observed in open-label studies 
c Observed during post-marketing 
d Observed in 2011 data pool of double-blind placebo-controlled studies 
 
Description of selected adverse reactions 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden 
sleep onset episodes. In isolated cases “sudden onset of sleep” occurred while driving and resulted in 
motor vehicle accidents (see also sections 4.4 and 4.7). 
 
Impulse control disorders 
 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see 
section 4.4). 
 



42 

 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
The most likely adverse reactions would be those related to the pharmacodynamic profile of a 
dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, 
confusion, convulsions and other signs of central dopaminergic stimulation. 
 
Management 
 
There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal 
of the patch(es) should be considered because after removal of the patch(es) the active substance input 
is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be 
monitored closely, including heart rate, heart rhythm and blood pressure.  
Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis 
would not be expected to be beneficial as rotigotine is not eliminated by dialysis. 
 
If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic 
malignant syndrome. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 
 
Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s 
disease and Restless Legs Syndrome.  
 
Mechanism of action 
 
Rotigotine is believed to elicit its beneficial effect on Parkinson’s disease by activation of the D3, D2 
and D1 receptors of the caudate-putamen in the brain. 
 
The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that 
rotigotine may exert its activity mainly via dopamine receptors. 
 
Pharmacodynamic effects 
 
Regarding the functional activity at the various receptor subtypes and their distribution in the brain, 
rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-
dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, 
but no activity on the 5HT2B receptor.  
 
Clinical efficacy and safety 
 
The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's 
disease was evaluated in a multinational drug development program consisting of four pivotal, 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


43 

parallel, randomized, double-blind placebo controlled studies and three studies investigating specific 
aspects of Parkinson’s disease. 
 
Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in 
the treatment of the signs and symptoms of idiopathic Parkinson’s disease were conducted in patients 
who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or 
previous L-dopa treatment was ≤ 6 months. The primary outcome assessment was the score for the 
Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part 
III) of the Unified Parkinson’s Disease Rating Scale (UPDRS).  
Efficacy was determined by the subject’s response to therapy in terms of responder and absolute 
points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III). 
 
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received 
placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments 
of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group 
were maintained at their optimal dose for 6 months. 
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the 
subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 
18%; 39%, p<0.0001). With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was 
-3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was 
observed (baseline 30.0 points). The difference was 5.28 points and statistically significant 
(p<0.0001).  
 
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 
117 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks. In the 
ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 
weeks. Patients in each treatment group were maintained for 6 months. 
At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the 
subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects 
receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference 
ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%, 
CI95% 7.6%; 25.7%). The mean improvement in the UPDRS score (Parts II + III) was 6.83 points 
(baseline 33.2 points) in the rotigotine arm, 10.78 points in the ropinirole arm (baseline 32.2 points) 
and 2.33 points in the placebo arm (baseline 31.3 points). All differences between the active 
treatments and placebo were statistically significant. This study failed to demonstrate non-inferiority 
of rotigotine to ropinirole.  
 
In a subsequent open-label study (SP824), a multicenter, multinational study, the tolerability of 
overnight switching from ropinirole, pramipexole or cabergoline to rotigotine transdermal patch and 
its effect on symptoms in subjects with idiopathic Parkinson’s disease have been studied. 116 patients 
were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 
47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up 
to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day. Switching to rotigotine 
was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients 
switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline. 
Improvements were seen in UPDRS Parts I - IV scores. The safety profile was unchanged from that 
observed in previous studies. 
 
In a randomized, open-label study (SP825) in patients with early-stage Parkinson’s disease, 25 
patients were randomized to rotigotine treatment and 26 to ropinirole. In both arms treatment was 
titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively. Both treatments showed 
improvements in early morning motor function and sleep. Motor symptoms (UPDRS Part III) 
improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-
group after 4 weeks of maintenance. Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-



44 

treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients. The safety profile was 
comparable, with the exception of application site reactions. 
 
In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at 
equivalent doses were shown to have comparable efficacy. 
 
Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving 
concomitant levodopa therapy. The primary outcome assessment was the reduction in “off” time 
(hours). Efficacy was determined by the subject’s response to therapy in terms of responder and 
absolute improvement in the time spent “off”. 
 
In the double blind study SP650DB, 113 patients received rotigotine up to a maximum dose of 
8 mg/24 h, 109 patients received rotigotine up to a maximum dose of 12 mg/24 h and 119 patients 
received placebo. The patients were titrated to their optimal doses of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h. Patients in each treatment group were maintained at 
their optimal dose for 6 months. At the end of the maintenance treatment an improvement of at least 
30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, 
respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, 
CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups). With rotigotine, the 
mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm 
a reduction of 0.9 hours was observed. The differences were statistically significant (p<0.001 and 
p=0.003, respectively). 
 
In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 
100 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h to a maximum dose of 16 mg/24 h. In the pramipexole 
group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated 
further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/day. 
Patients in each treatment group were maintained for 4 months. 
At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the 
subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects 
receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole 
versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%). 
The mean reduction in the “off” time was 2.5 hours in the rotigotine arm, 2.8 hours in the pramipexole 
arm and 0.9 hours in the placebo arm. All differences between the active treatments and placebo were 
statistically significant.  
 
A further multinational double-blind study (SP889) was conducted in 287 patients with early or 
advanced stages of Parkinson’s disease who had unsatisfactory early morning motor symptom control. 
81.5% of these patients were on concomitant levodopa therapy. 190 patients received rotigotine, and 
97 placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 16 mg/24 h over 8 weeks, 
followed by a maintenance period of 4 weeks. Early morning motor function, assessed by UPDRS part 
III, and nocturnal sleep disturbances, measured by the modified Parkinson’s Disease Sleep Scale 
(PDSS-2), were co-primary outcome measures. At the end of maintenance, the mean UPDRS part III 
score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the 
placebo-group (baseline 32.0). Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, 
baseline 19.3) and 1.9 points (placebo, baseline 20.5). Treatment differences for the coprimary 
variables were statistically significant (p=0.0002 and p<0.0001). 
 
Skin adhesion 
 
In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin 
adhesion of the improved room temperature patch formulation was compared to the cold storage 
formulation, using the 8 mg/24 h rotigotine patch. Skin adhesion was measured on 2 consecutive days 
of 24 hours patch application. The improved room temperature patch formulation showed better skin 
adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. 



45 

>70% of the patch area adhering) compared to <83%. Comparable skin tolerability was reported for 
both formulations. The majority of erythema observed was mild and none severe. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following application, rotigotine is continuously released from the transdermal patch and absorbed 
through the skin. Steady-state concentrations are reached after one to two days of patch application 
and are maintained at a stable level by once daily application in which the patch is worn for 24 hours. 
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/24 h to 
24 mg/24 h. 
 
Approximately 45% of the active substance within the patch is released to the skin in 24 hours. The 
absolute bioavailability after transdermal application is approximately 37%. 
 
Rotating the site of patch application may result in day-to-day differences in plasma levels. 
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder 
versus thigh). However, there is no indication of a relevant impact on the clinical outcome. 
 
Distribution 
 
The in vitro binding of rotigotine to plasma proteins is approximately 92%. 
The apparent volume of distribution in humans is approximately 84 l/kg. 
 
Biotransformation 
 
Rotigotine is metabolised to a great extent. Rotigotine is metabolised by N-dealkylation as well as 
direct and secondary conjugation. In vitro results indicate that different CYP isoforms are able to 
catalyse the N-dealkylation of rotigotine. Main metabolites are sulfates and glucuronide conjugates of 
the parent compound as well as N-desalkyl-metabolites, which are biologically inactive. 
The information on metabolites is incomplete. 
 
Elimination 
 
Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is 
excreted in faeces. 
The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall 
elimination half-life is 5 to 7 hours. The pharmacokinetic profile shows a biphasic elimination with an 
initial half-life of about 2 to 3 hours. 
 
Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is 
expected. 
 
Special patient groups 
 
Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical 
tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, 
or age is not necessary. 
 
Hepatic and renal impairment 
 
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant 
increases of rotigotine plasma levels were observed. Leganto was not investigated in patients with 
severe hepatic impairment.  
Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal 
function. However, a contribution of these metabolites to clinical effects is unlikely. 



46 

 
5.3 Preclinical safety data 
 
In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine 
agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.  
After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat 
and monkey was evident, but was slowly cleared over the 14-day observation period. 
Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the 
maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats. The effects 
were more pronounced in female rats. Additional studies to further evaluate the specific pathology 
have not been performed. Retinal degeneration was not observed during the routine histopathological 
evaluation of the eyes in any of the toxicology studies in any species used. The relevance of these 
findings to humans is not known. 
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia. Malignant 
tumours were noted predominantly in the uterus of mid- and high-dose females. These changes are 
well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to 
man. 
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice. Rotigotine 
was not teratogenic in all three species, but was embryotoxic in rats and mice at materno-toxic doses. 
Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, 
because of the effects on prolactin levels which are particularly significant in rodents. 
 
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse 
Lymphoma Assay with metabolic activation and weaker effects without metabolic activation. This 
mutagenic effect could be attributed to a clastogenic effect of rotigotine. This effect was not confirmed 
in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test. Since it 
ran more or less parallel with a decreased relative total growth of the cells, it may be related to a 
cytotoxic effect of the compound. Therefore, the relevance of the one positive in vitro mutagenicity 
test is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing layer  
 
Polyester film, siliconized, aluminized,  
colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and 
imprinted (pigment red 144, pigment yellow 95, pigment black 7). 
 
Self adhesive matrix layer  
 
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate,  
Povidone K90,  
sodium metabisulphite (E223),  
ascorbyl palmitate (E304) and  
DL-α-tocopherol (E307). 
 
Release liner  
 
Transparent fluoropolymer coated polyester film. 
 
6.2 Incompatibilities 
 
Not applicable. 
 



47 

6.3 Shelf life 
 
30 months. 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
6.5 Nature and contents of container 
 
Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an 
aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene 
(innermost layer), aluminium, ethylene copolymer and paper. 
 
The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, 
individually sealed in sachets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precaution for disposal 
 
After use the patch still contains active substance. After removal, the used patch should be folded in 
half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and 
then discarded. Any used or unused patches should be disposed of in accordance with local 
requirements or returned to the pharmacy. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Leganto 4 mg/24 h transdermal patch 
EU/1/11/695/028 
EU/1/11/695/030 
EU/1/11/695/031 
EU/1/11/695/034 
 
Leganto 6 mg/24 h transdermal patch 
EU/1/11/695/037 
EU/1/11/695/039 
EU/1/11/695/040 
EU/1/11/695/043 
 
Leganto 8 mg/24 h transdermal patch 
EU/1/11/695/046 
EU/1/11/695/048 
EU/1/11/695/049 
EU/1/11/695/052 
 
 



48 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 June 2011 
Date of latest renewal: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


49 

1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 
2 mg/24 h  
4 mg/24 h  
6 mg/24 h  
8 mg/24 h  
Transdermal patch 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Leganto 2 mg/24 h transdermal patch 
Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm2 contains 4.5 mg of 
rotigotine.  
 
Leganto 4 mg/24 h transdermal patch 
Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 20 cm2 contains 9.0 mg of 
rotigotine. 
 
Leganto 6 mg/24 h transdermal patch 
Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30 cm2 contains 13.5 mg of 
rotigotine.  
 
Leganto 8 mg/24 h transdermal patch 
Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 cm2 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. The outside of the 
backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 
8 mg/24 h’. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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). 
 
4.2 Posology and method of administration 
 
Posology 
 
The dose recommendations made are in nominal dose. 
 



50 

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. 
 
Dosing in patients with advanced stage Parkinson’s disease with fluctuations: 
A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 
2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 
4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is 
reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h. 
 
Leganto treatment initiation pack contains 4 different packages (one for each strength) with 7 patches 
each, for the first four weeks of therapy.  
Depending on the patient’s response, not all of the following dose steps may be required or additional 
higher doses may be needed after week 4, which are not covered by this package. 
On the first day of treatment the patient starts with Leganto 2 mg/24 h. During the second week, the 
patient takes Leganto 4 mg/24 h. During the third week, he or she takes Leganto 6 mg/24 h and during 
the fourth week Leganto 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”. 
 
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. 
 
Treatment discontinuation 
 
Leganto should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h 
with a dose reduction preferably every other day, until complete withdrawal of Leganto (see 
section 4.4). 
 
Special populations 
 
Hepatic impairment 
 
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution 
is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine 
clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be 
needed in case of worsening of the hepatic impairment.  
 
Renal impairment 
 
Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including 
those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute 
worsening of renal function (see section 5.2). 
 
Paediatric population 
 
There is no relevant use of Leganto in the paediatric population in Parkinson’s disease. 
 
Method of administration 
 
Leganto is for transdermal use. 
 



51 

The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, 
shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Leganto 
should not be placed on skin that is red, irritated or damaged (see section 4.4). 
 
Use and handling 
 
Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One 
half of the release liner should be removed and the sticky side should be applied and pressed firmly to 
the skin. Then, the patch is fold back and the second part of the release liner is removed. The sticky 
side of the patch should not be touched. The patch should be pressed down firmly with the palm of the 
hand for about 30 seconds, so that it sticks well. 
 
The patch should not be cut into pieces. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Magnetic resonance imaging or cardioversion (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
If a Parkinson’s disease patient is insufficiently controlled while on treatment with rotigotine 
switching to another dopamine agonist might provide additional benefit (see section 5.1) 
 
Magnetic resonance imaging and cardioversion 
 
The backing layer of Leganto contains aluminium. To avoid skin burns, Leganto should be removed if 
the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. 
 
Orthostatic hypotension 
 
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in 
postural/orthostatic hypotension. These events have also been observed during treatment with 
rotigotine, but the incidence was similar to that observed in placebo-treated patients. 
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the 
general risk of orthostatic hypotension associated with dopaminergic therapy. 
 
Syncope 
 
In clinical trial studies with rotigotine, syncope has been observed at a rate that was similar to that 
observed in patients treated with placebo. Because patients with clinically relevant cardiovascular 
disease were excluded in these studies, patients with severe cardiovascular disease should be asked 
about symptoms of syncope and pre-syncope. 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of 
sleep during daily activities, in some cases without awareness of any warning signs, has been reported. 
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not 
acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination 
of therapy should be carefully considered.  
 
Impulse control disorders 
 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 



52 

and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. Dose 
reduction/tapered discontinuation should be considered if such symptoms develop. 
 
Neuroleptic malignant syndrome 
 
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal 
of dopaminergic therapy. Therefore, it is recommended to taper treatment (see section 4.2). 
 
Abnormal thinking and behaviour 
 
Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations 
including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, 
disorientation, aggressive behaviour, agitation, and delirium. 
 
Fibrotic complications 
 
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, 
pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived 
dopaminergic agents. While these complications may resolve when treatment is discontinued, 
complete resolution does not always occur. 
Although these adverse reactions are believed to be related to the ergoline structure of these 
compounds, whether other, nonergot derived dopamine agonists can cause them is unknown. 
 
Neuroleptics 
 
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also 
section 4.5). 
 
Ophthalmologic monitoring 
 
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 
 
Heat application 
 
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) 
should not be applied to the area of the patch. 
 
Application site reactions 
 
Application site skin reactions may occur and are usually mild or moderate in intensity. It is 
recommended that the application site should be rotated on a daily basis (e.g. from the right side to the 
left side and from the upper body to the lower body). The same site should not be used within 14 days. 
If application site reactions occur which last for more than a few days or are persistent, if there is an 
increase in severity, or if the skin reaction spreads outside the application site, an assessment of the 
risk/benefit balance for the individual patient should be conducted. 
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be 
avoided until the skin heals, as exposure could lead to changes in the skin color. 
If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or 
pruritus) associated with the use of Leganto is observed, Leganto should be discontinued. 
 
Peripheral oedema 
 
In clinical studies in Parkinson’s patients, the 6 month-specific rates of peripheral oedema remained at 
about 4% through the entire observation period up to 36 months. 
 
Dopaminergic adverse reactions 
 



53 

The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and 
peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’s patients. 
This should be considered when prescribing rotigotine. 
 
Sulphite sensitivity 
 
Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including 
anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible 
people. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as 
neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish 
the effectiveness of Leganto, and co-administration should be avoided. Because of possible additive 
effects, caution should be advised when patients are taking sedating medicinal products or other CNS 
(central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol 
in combination with rotigotine. 
 
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of 
rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa. 
 
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.  
 
Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the 
pharmacokinetics and metabolism of rotigotine in healthy volunteers. 
 
Leganto may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate 
pre-existing dyskinesia, as described with other dopamine agonists. 
 
Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and 
pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).  
Interactions with other forms of hormonal contraception have not been investigated. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential, contraception in females 
 
Women of childbearing potential should use effective contraception to prevent pregnancy during 
treatment with rotigotine. 
 
Pregnancy 
 
There are no adequate data from the use of rotigotine in pregnant women. Animal studies do not 
indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice 
at materno-toxic doses (see section 5.3). The potential risk for humans is unknown. Rotigotine should 
not be used during pregnancy.  
 
Breast-feeding 
 
Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected. Studies 
in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. In the absence of 
human data, breast-feeding should be discontinued. 
 
Fertility 
 
For information on fertility studies, please see section 5.3. 



54 

 
4.7 Effects on ability to drive and use machines 
 
Rotigotine may have major influence on the ability to drive and use machines. 
Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes 
must be informed not to drive or engage in activities (e.g. operating machines) where impaired 
alertness may put themselves or others at risk of serious injury or death until such recurrent episodes 
and somnolence have resolved (see also sections 4.4 and 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Leganto- 
and 607 placebo-treated patients, 72.5% of the patients on Leganto and 58.0% of patients on placebo 
reported at least one adverse reaction. 
 
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. 
These are usually mild or moderate in intensity and transient even if treatment is continued. 
 
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto 
transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and 
headache. 
 
In trials where the application sites were rotated as reflected in the instructions provided in SmPC and 
package leaflet, 35.7% of 830 patients using the Leganto transdermal patch, experienced application 
site reactions. The majority of application site reactions were mild or moderate in intensity, limited to 
the application areas and resulted in discontinuation of treatment with Leganto in only 4.3% of all 
subjects receiving Leganto. 
 
Tabulated list of adverse reactions 
 
The following table covers adverse drug reactions from the pooled studies mentioned above in patients 
with Parkinson’s disease and from post-marketing experience. Within the system organ classes, 
adverse reactions are listed under headings of frequency (number of patients expected to experience 
the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 
System/organ 
classes acc. to 

MedDRA 

Very common 
 

Common 
 

Uncommon 
 

Rare 
 

Not known 

Immune system 
disorders 

  Hypersensitivity, 
which may 
include 
angioedema, 
tongue oedema 
and lip oedema 

  



55 

Psychiatric 
disorders 

 Perception 
disturbancesa 
(incl. 
hallucination, 
hallucination 
visual, 
hallucination 
auditory, 
illusion), 
insomnia, sleep 
disorder, 
nightmare, 
abnormal 
dreams, 
impulse-
control 
disordersa,d 
(incl. 
pathological 
gambling, 
stereotypy/ 
punding, binge 
eating/eating 
disorderb, 
compulsive 
shoppingc) 

Sleep 
attacks/sudden 
onset of sleep, 
paranoia, sexual 
desire disordersa 
(incl. 
hypersexuality, 
libido 
increased), 
confusional 
state, 
disorientationd, 
agitationd 

Psychotic 
disorder, 
obsessive-
compulsive 
disorder, 
aggressive 
behaviour/ 
aggressionb, 
delusiond, 
deliriumd 

Dopamine 
dysregulation 
syndromec 

Nervous system 
disorders 

Somnolence, 
dizziness, 
headache 

Disturbances in 
consciousness 
NECa (incl. 
syncope, 
syncope 
vasovagal, loss 
of 
consciousness), 
dyskinesia, 
dizziness 
postural, 
lethargy 

 Convulsion  Dropped head 
syndromec 

Eye disorders 
 

  Vision blurred, 
visual 
impairment, 
photopsia 

  

Ear and 
labyrinth 
disorders 

 Vertigo    

Cardiac 
disorders 

 Palpitations Atrial fibrillation  Supraventricular 
tachycardia 

 

Vascular 
disorders 

 Orthostatic 
hypotension, 
hypertension  

Hypotension   

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Hiccups    

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Constipation, 
dry mouth, 
dyspepsia 

Abdominal pain  
 

 Diarrhoeac 



56 

Skin and 
subcutaneous 
tissue disorders 

 Erythema, 
hyperhidrosis, 
pruritus 

Pruritus 
generalised, skin 
irritation, 
dermatitis 
contact 

Rash 
generalised 

 

Reproductive 
system and 
breast disorder 

  Erectile 
dysfunction 

  

General 
disorders and 
administration 
site conditions 

Application and 
instillation site 
reactionsa (incl. 
erythema, 
pruritus, 
irritation, rash, 
dermatitis, 
vesicles, pain, 
eczema, 
inflammation, 
swelling, 
discolouration, 
papules, 
exfoliation, 
urticaria, 
hypersensitivity) 

Oedema 
peripheral, 
asthenic 
conditionsa 
(incl. fatigue, 
asthenia, 
malaise) 

 Irritability 
 

 

Investigations  Weight 
decreased 

Hepatic enzyme 
increased (incl. 
AST, ALT, 
GGT), weight 
increased, heart 
rate increased, 
CPK increasedd  

  

Injury, 
poisoning and 
procedural 
complications 

 Fall    

Musculoskeletal 
and connective 
tissue disorders 

    Rhabdomyolysisc 

a High Level Term 
b Observed in open-label studies 
c Observed during post-marketing 
d Observed in 2011 data pool of double-blind placebo-controlled studies 
 
Description of selected adverse reactions 
 
Sudden onset of sleep and somnolence 
 
Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden 
sleep onset episodes. In isolated cases “sudden onset of sleep” occurred while driving and resulted in 
motor vehicle accidents (see also sections 4.4 and 4.7). 
 
Impulse control disorders 
 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see 
section 4.4). 
 



57 

 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
The most likely adverse reactions would be those related to the pharmacodynamic profile of a 
dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, 
confusion, convulsions and other signs of central dopaminergic stimulation. 
 
Management 
 
There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal 
of the patch(es) should be considered because after removal of the patch(es) the active substance input 
is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be 
monitored closely, including heart rate, heart rhythm and blood pressure.  
Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis 
would not be expected to be beneficial as rotigotine is not eliminated by dialysis. 
 
If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic 
malignant syndrome. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 
 
Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s 
disease and Restless Legs Syndrome.  
 
Mechanism of action 
 
Rotigotine is believed to elicit its beneficial effect on Parkinson’s disease by activation of the D3, D2 
and D1 receptors of the caudate-putamen in the brain. 
 
The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that 
rotigotine may exert its activity mainly via dopamine receptors. 
 
Pharmacodynamic effects 
 
Regarding the functional activity at the various receptor subtypes and their distribution in the brain, 
rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-
dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, 
but no activity on the 5HT2B receptor.  
 
Clinical efficacy and safety 
 
The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's 
disease was evaluated in a multinational drug development program consisting of four pivotal, 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


58 

parallel, randomized, double-blind placebo controlled studies and three studies investigating specific 
aspects of Parkinson’s disease. 
 
Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in 
the treatment of the signs and symptoms of idiopathic Parkinson’s disease were conducted in patients 
who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or 
previous L-dopa treatment was ≤ 6 months. The primary outcome assessment was the score for the 
Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part 
III) of the Unified Parkinson’s Disease Rating Scale (UPDRS).  
Efficacy was determined by the subject’s response to therapy in terms of responder and absolute 
points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III). 
 
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received 
placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments 
of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group 
were maintained at their optimal dose for 6 months. 
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the 
subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 
18%; 39%, p<0.0001). With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was 
-3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was 
observed (baseline 30.0 points). The difference was 5.28 points and statistically significant 
(p<0.0001).  
 
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 
117 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks. In the 
ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 
weeks. Patients in each treatment group were maintained for 6 months. 
At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose 
was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the 
subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects 
receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference 
ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%, 
CI95% 7.6%; 25.7%). The mean improvement in the UPDRS score (Parts II + III) was 6.83 points 
(baseline 33.2 points) in the rotigotine arm, 10.78 points in the ropinirole arm (baseline 32.2 points) 
and 2.33 points in the placebo arm (baseline 31.3 points). All differences between the active 
treatments and placebo were statistically significant. This study failed to demonstrate non-inferiority 
of rotigotine to ropinirole.  
 
In a subsequent open-label study (SP824), a multicenter, multinational study, the tolerability of 
overnight switching from ropinirole, pramipexole or cabergoline to rotigotine transdermal patch and 
its effect on symptoms in subjects with idiopathic Parkinson’s disease have been studied. 116 patients 
were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 
47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up 
to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day. Switching to rotigotine 
was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients 
switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline. 
Improvements were seen in UPDRS Parts I - IV scores. The safety profile was unchanged from that 
observed in previous studies. 
 
In a randomized, open-label study (SP825) in patients with early-stage Parkinson’s disease, 25 
patients were randomized to rotigotine treatment and 26 to ropinirole. In both arms treatment was 
titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively. Both treatments showed 
improvements in early morning motor function and sleep. Motor symptoms (UPDRS Part III) 
improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-
group after 4 weeks of maintenance. Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-



59 

treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients. The safety profile was 
comparable, with the exception of application site reactions. 
 
In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at 
equivalent doses were shown to have comparable efficacy. 
 
Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving 
concomitant levodopa therapy. The primary outcome assessment was the reduction in “off” time 
(hours). Efficacy was determined by the subject’s response to therapy in terms of responder and 
absolute improvement in the time spent “off”. 
 
In the double blind study SP650DB, 113 patients received rotigotine up to a maximum dose of 
8 mg/24 h, 109 patients received rotigotine up to a maximum dose of 12 mg/24 h and 119 patients 
received placebo. The patients were titrated to their optimal doses of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h. Patients in each treatment group were maintained at 
their optimal dose for 6 months. At the end of the maintenance treatment an improvement of at least 
30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, 
respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, 
CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups). With rotigotine, the 
mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm 
a reduction of 0.9 hours was observed. The differences were statistically significant (p<0.001 and 
p=0.003, respectively). 
 
In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 
100 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly 
increments of 2 mg/24 h starting at 4 mg/24 h to a maximum dose of 16 mg/24 h. In the pramipexole 
group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated 
further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/day. 
Patients in each treatment group were maintained for 4 months. 
At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the 
subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects 
receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole 
versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%). 
The mean reduction in the “off” time was 2.5 hours in the rotigotine arm, 2.8 hours in the pramipexole 
arm and 0.9 hours in the placebo arm. All differences between the active treatments and placebo were 
statistically significant.  
 
A further multinational double-blind study (SP889) was conducted in 287 patients with early or 
advanced stages of Parkinson’s disease who had unsatisfactory early morning motor symptom control. 
81.5% of these patients were on concomitant levodopa therapy. 190 patients received rotigotine, and 
97 placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly 
increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 16 mg/24 h over 8 weeks, 
followed by a maintenance period of 4 weeks. Early morning motor function, assessed by UPDRS part 
III, and nocturnal sleep disturbances, measured by the modified Parkinson’s Disease Sleep Scale 
(PDSS-2), were co-primary outcome measures. At the end of maintenance, the mean UPDRS part III 
score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the 
placebo-group (baseline 32.0). Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, 
baseline 19.3) and 1.9 points (placebo, baseline 20.5). Treatment differences for the coprimary 
variables were statistically significant (p=0.0002 and p<0.0001). 
 
Skin adhesion 
 
In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin 
adhesion of the improved room temperature patch formulation was compared to the cold storage 
formulation, using the 8 mg/24 h rotigotine patch. Skin adhesion was measured on 2 consecutive days 
of 24 hours patch application. The improved room temperature patch formulation showed better skin 
adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. 



60 

>70% of the patch area adhering) compared to <83%. Comparable skin tolerability was reported for 
both formulations. The majority of erythema observed was mild and none severe. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following application, rotigotine is continuously released from the transdermal patch and absorbed 
through the skin. Steady-state concentrations are reached after one to two days of patch application 
and are maintained at a stable level by once daily application in which the patch is worn for 24 hours. 
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/24 h to 
24 mg/24 h. 
 
Approximately 45% of the active substance within the patch is released to the skin in 24 hours. The 
absolute bioavailability after transdermal application is approximately 37%. 
 
Rotating the site of patch application may result in day-to-day differences in plasma levels. 
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder 
versus thigh). However, there is no indication of a relevant impact on the clinical outcome. 
 
Distribution 
 
The in vitro binding of rotigotine to plasma proteins is approximately 92%. 
The apparent volume of distribution in humans is approximately 84 l/kg. 
 
Biotransformation 
 
Rotigotine is metabolised to a great extent. Rotigotine is metabolised by N-dealkylation as well as 
direct and secondary conjugation. In vitro results indicate that different CYP isoforms are able to 
catalyse the N-dealkylation of rotigotine. Main metabolites are sulfates and glucuronide conjugates of 
the parent compound as well as N-desalkyl-metabolites, which are biologically inactive. 
The information on metabolites is incomplete. 
 
Elimination 
 
Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is 
excreted in faeces. 
The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall 
elimination half-life is 5 to 7 hours. The pharmacokinetic profile shows a biphasic elimination with an 
initial half-life of about 2 to 3 hours. 
 
Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is 
expected. 
 
Special patient groups 
 
Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical 
tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, 
or age is not necessary. 
 
Hepatic and renal impairment 
 
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant 
increases of rotigotine plasma levels were observed. Leganto was not investigated in patients with 
severe hepatic impairment.  
Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal 
function. However, a contribution of these metabolites to clinical effects is unlikely. 



61 

 
5.3 Preclinical safety data 
 
In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine 
agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.  
After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat 
and monkey was evident, but was slowly cleared over the 14-day observation period. 
Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the 
maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats. The effects 
were more pronounced in female rats. Additional studies to further evaluate the specific pathology 
have not been performed. Retinal degeneration was not observed during the routine histopathological 
evaluation of the eyes in any of the toxicology studies in any species used. The relevance of these 
findings to humans is not known. 
In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia. Malignant 
tumours were noted predominantly in the uterus of mid- and high-dose females. These changes are 
well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to 
man. 
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice. Rotigotine 
was not teratogenic in all three species, but was embryotoxic in rats and mice at materno-toxic doses. 
Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, 
because of the effects on prolactin levels which are particularly significant in rodents. 
 
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse 
Lymphoma Assay with metabolic activation and weaker effects without metabolic activation. This 
mutagenic effect could be attributed to a clastogenic effect of rotigotine. This effect was not confirmed 
in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test. Since it 
ran more or less parallel with a decreased relative total growth of the cells, it may be related to a 
cytotoxic effect of the compound. Therefore, the relevance of the one positive in vitro mutagenicity 
test is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing layer  
 
Polyester film, siliconized, aluminized,  
colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and 
imprinted (pigment red 144, pigment yellow 95, pigment black 7). 
 
Self adhesive matrix layer  
 
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate,  
Povidone K90,  
sodium metabisulphite (E223),  
ascorbyl palmitate (E304) and  
DL-α-tocopherol (E307). 
 
Release liner  
 
Transparent fluoropolymer coated polyester film. 
 
6.2 Incompatibilities 
 
Not applicable. 
 



62 

6.3 Shelf life 
 
30 months. 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
6.5 Nature and contents of container 
 
Peel off sachet in a cardboard carton: One side is composed of an ethylene copolymer (innermost 
layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of 
polyethylene (innermost layer), aluminium, ethylene copolymer and paper. 
 
The treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 
4 mg, 6 mg, and 8 mg each, individually sealed in sachets. 
 
6.6 Special precaution for disposal 
 
After use the patch still contains active substance. After removal, the used patch should be folded in 
half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and 
then discarded. Any used or unused patches should be disposed of in accordance with local 
requirements or returned to the pharmacy. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 June 2011 
Date of latest renewal: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



64 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l’Alleud 
Belgium 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING  

AUTHORISATION 
 
• Periodic Safety Update Reports 
  
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted 
• At the request of the European Medicines Agency 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached 

 



65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



67 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 1 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 1 mg of rotigotine per 24 hours. 
Each patch of 5 cm2 contains 2.25 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 



68 

 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/001 [7 transdermal patches] 
EU/1/11/695/003 [28 transdermal patches] 
EU/1/11/695/004 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 1 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 



69 

MULTIPACKS ONLY  
OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 1 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 1 mg of rotigotine per 24 hours. 
Each patch of 5 cm2 contains 2.25 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 



70 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/007 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 1 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



71 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 1 mg/24 h transdermal patch 
rotigotine 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 1 mg of rotigotine per 24 hours. 
Each patch of 5 cm2 contains 2.25 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



72 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/007 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 1 mg/24 h 

 



73 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 1 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



74 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 2 mg of rotigotine per 24 hours. 
Each patch of 10 cm2 contains 4.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
 4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



75 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/010 [7 transdermal patches] 
EU/1/11/695/012 [28 transdermal patches] 
EU/1/11/695/013 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 2 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY  



76 

OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 2 mg of rotigotine per 24 hours. 
Each patch of 10 cm2 contains 4.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 



77 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/016 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 2 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:



78 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 2 mg of rotigotine per 24 hours. 
Each patch of 10 cm2 contains 4.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



79 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/016 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 2 mg/24 h 

 



80 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



81 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 3 mg/24 h transdermal patch 
rotigotine 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 3 mg of rotigotine per 24 hours. 
Each patch of 15 cm2 contains 6.75 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



82 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/019 [7 transdermal patches] 
EU/1/11/695/021 [28 transdermal patches] 
EU/1/11/695/022 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 3 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY  



83 

OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 3 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 3 mg of rotigotine per 24 hours. 
Each patch of 15 cm2 contains 6.75 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 



84 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/025 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 3 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



85 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 3 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 3 mg of rotigotine per 24 hours. 
Each patch of 15 cm2 contains 6.75 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



86 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/025 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 3 mg/24 h 

 



87 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 3 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



88 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 4 mg of rotigotine per 24 hours. 
Each patch of 20 cm2 contains 9.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 



89 

 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/028 [7 transdermal patches] 
EU/1/11/695/030 [28 transdermal patches] 
EU/1/11/695/031 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 4 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 



90 

MULTIPACKS ONLY  
OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 4 mg of rotigotine per 24 hours. 
Each patch of 20 cm2 contains 9.0 mg of rotigotine. 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 



91 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/034 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 4 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



92 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 4 mg of rotigotine per 24 hours. 
Each patch of 20 cm2 contains 9.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



93 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/034 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 4 mg/24 h 
 



94 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



95 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 6 mg of rotigotine per 24 hours. 
Each patch of 30 cm2 contains 13.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 



96 

 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/037 [7 transdermal patches] 
EU/1/11/695/039 [28 transdermal patches] 
EU/1/11/695/040 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 6 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 



97 

MULTIPACKS ONLY  
OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 6 mg of rotigotine per 24 hours. 
Each patch of 30 cm2 contains 13.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
 4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 



98 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/043 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 6 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



99 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 6 mg of rotigotine per 24 hours. 
Each patch of 30 cm2 contains 13.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
 
 4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



100 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/043 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 6 mg/24 h 



101 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



102 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOX OF 7 [28] [30] PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 8 mg of rotigotine per 24 hours. 
Each patch of 40 cm2 contains 18.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches 
28 transdermal patches 
30 transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



103 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/046 [7 transdermal patches] 
EU/1/11/695/048 [28 transdermal patches] 
EU/1/11/695/049 [30 transdermal patches] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 8 mg/24 h  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



104 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY  
OUTER LABEL (WITH BLUE BOX) 
BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 8 mg of rotigotine per 24 hours. 
Each patch of 40 cm2 contains 18.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (3 packs of 28) transdermal patches 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



105 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/052 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 8 mg/24 h  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



106 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS ONLY 
INTERMEDIATE BOX (WITHOUT BLUE BOX)  
BOX OF 28 PATCHES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 8 mg of rotigotine per 24 hours. 
Each patch of 40 cm2 contains 18.0 mg of rotigotine. 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 transdermal patches. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



107 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/052 [84 transdermal patches (3 packs of 28)] 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 8 mg/24 h  
 



108 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



109 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 
2 mg/24 h 
4 mg/24 h 
6 mg/24 h 
8 mg/24 h 
 
Transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Leganto 2 mg/24 h 
Each patch releases 2 mg of rotigotine per 24 hours. 
Each patch of 10 cm2 contains 4.5 mg of rotigotine. 
 
Leganto 4 mg/24 h 
Each patch releases 4 mg of rotigotine per 24 hours. 
Each patch of 20 cm2 contains 9.0 mg of rotigotine. 
 
Leganto 6 mg/24 h 
Each patch releases 6 mg of rotigotine per 24 hours. 
Each patch of 30 cm2 contains 13.5 mg of rotigotine. 
 
Leganto 8 mg/24 h 
Each patch releases 8 mg of rotigotine per 24 hours. 
Each patch of 40 cm2 contains 18.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Treatment initiation pack  
Each pack of 28 transdermal patches for a 4 week treatment schedule contains: 
7 transdermal patches of Leganto 2 mg/24 h 
7 transdermal patches of Leganto 4 mg/24 h 
7 transdermal patches of Leganto 6 mg/24 h 
7 transdermal patches of Leganto 8 mg/24 h 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 



110 

 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



111 

16. INFORMATION IN BRAILLE 
 
leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



112 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
BOX OF 7 PATCHES – WEEK 1 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 2 mg of rotigotine per 24 hours. 
Each patch of 10 cm2 contains 4.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches. 
Week 1. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Transdermal use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



113 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 2 mg/24 h 



114 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL – WEEK 1 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 2 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
Week 1 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



115 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
BOX OF 7 PATCHES – WEEK 2 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 4 mg of rotigotine per 24 hours. 
Each patch of 20 cm2 contains 9.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches.  
Week 2. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 



116 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 4 mg/24 h 



117 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL – WEEK 2 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 4 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
Week 2 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



118 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
BOX OF 7 PATCHES – WEEK 3 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 6 mg of rotigotine per 24 hours. 
Each patch of 30 cm2 contains 13.5 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
 
  
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches. 
Week 3. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 



119 

Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 6 mg/24 h 



120 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL - WEEK 3 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 6 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
Week 3 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



121 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
BOX OF 7 PATCHES – WEEK 4 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each patch releases 8 mg of rotigotine per 24 hours. 
Each patch of 40 cm2 contains 18.0 mg of rotigotine. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, 
E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, 
red144, black7) 
Contains E223. See leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 transdermal patches. 
Week 4 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
 OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
 
 



122 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
 APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/695/055 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
leganto 8 mg/24 h 



123 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABEL – WEEK 4 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Leganto 8 mg/24 h transdermal patch 
rotigotine 
Transdermal use 
 
Week 4 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 



124 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



125 

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. 
- 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. 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 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 Leganto. If you are not sure about this, talk to your doctor 
or pharmacist first. 
 



126 

Warnings and precautions 
Talk to your doctor or pharmacist before using Leganto. This is because: 
 
• your blood pressure needs checking regularly while using Leganto, especially at the start of the 

treatment. Leganto may affect your blood pressure. 
• your eyes need checking regularly while using Leganto. If you notice any problems with your 

eyesight between checks, talk to your doctor straight away. 
• if you have serious liver problems, your doctor may need to change the dose. If your liver 

problems get worse during treatment, talk to your doctor straight away. 
• you may get skin problems caused by the patch – see ‘Skin problems caused by the patch’ in 

section 4. 
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in 

section 2. 
• your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and 

involve other limbs. If you experience such symptoms either before or after beginning treatment 
with Leganto, contact your doctor as your treatment may need to be adjusted. 

 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Leganto can cause side effects that change your behaviour (how you act). You may find it helpful to 
tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. 
This is so that your family or carer can tell you, or your doctor, if they are worried about any changes 
in your behaviour. 
 
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information. 
 
Children and adolescents 
Do not give this medicine to children below 18 years of age because it is not known if it is safe or 
effective in this age group. 
 
Other medicines and Leganto 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. 
 
Do not take the following medicines while using Leganto, – because they may decrease its effect:  
• ‘anti-psychotic’ medicines – used to treat certain mental illnesses 
•  metoclopramide – used to treat nausea (feeling sick) and vomiting.  
 
Talk to your doctor before using Leganto if you are taking: 
• sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 
• medicines that lower blood pressure. Leganto may decrease blood pressure when you stand up – 

this effect may be worsened by the medicines used to lower blood pressure. 
 
Your doctor will let you know if it is safe to keep taking these medicines while using Leganto. 
 
Leganto with food, drink and alcohol 
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way 
this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to 
drink alcohol while using Leganto. 
 



127 

Pregnancy and breast-feeding 
Do not use Leganto if you are pregnant. This is because the effects of rotigotine on pregnancy and the 
unborn baby are not known.  
 
Do not breast-feed during treatment with Leganto. This is because rotigotine may pass into your breast 
milk and affect your baby. It is also likely to lower the amount of milk you produce. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine. 
 
Driving and using machines 
Leganto may make you feel very sleepy, and you may fall asleep very suddenly. If this happens, do not 
drive. In isolated cases, people have fallen asleep while driving and this has caused accidents. 
 
Also do not use tools or machines if you feel very sleepy – or do anything else which may put others 
or yourself at risk of serious injury. 
 
Leganto contains sodium metabisulphite (E223) 
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and 
bronchospasm (breathing distress caused by narrowing of the airways). 
 
 
3. How to use Leganto 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Which strength patches to use 
Leganto is available in different strength patches which release the medicine over 24 hours.The 
strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome. 
 
• Your starting dose will be one, 1 mg/24 h patch each day.  
• From the second week, your daily dose may be increased by 1 mg each week until you get to the 

right maintenance dose for you. This is when you and your doctor agree that the symptoms are 
being controlled well enough and the side effects of the medicines are acceptable. 

• Please follow the instructions of the prescriber carefully. 
• The maximum dose is 3 mg per day. 
 
If you have to stop taking this medicine, see ‘If you stop using Leganto’ in section 3. 
 
How to use the Leganto patches  
Leganto is a patch that is put on the skin. 
• Make sure that you take the old patch off before putting on a new one. 
• Stick the new patch on a different area of the skin each day.  
• Leave the patch on your skin for 24 hours, then take it off and put on a new one. 
• Change the patches at about the same time every day. 
• Do not cut the Leganto patches into pieces. 
 



128 

Where to stick the patch 
 
Put the sticky side of the patch onto clean, dry, 
healthy skin on the following areas as shown in grey on 
the pictures opposite:  
• Shoulder or upper arm. 
• Belly. 
• Flank (your side, between the ribs 

and hips). 
• Thigh or hip. 

 
 
To avoid skin irritation  
• Stick the patch onto a different area of skin each day. For 

example, put it on the right side of your body one day, then 
on the left side of your body the next day. Or on your upper 
body one day, then on your lower body the day after that.  

• Do not stick Leganto on the same area of skin twice 
within 14 days. 

• Do not stick the patch on broken or damaged skin – or on 
skin that is red or irritated. 

 

 

If you still get problems with your skin because of the patch, please see ‘Skin problems caused by 
the patch’ in section 4 for more information.  
 
To prevent the patch becoming loose or falling off 
• Do not put the patch in an area where it can be rubbed by tight clothing. 
• Do not use creams, oils, lotions, powders or other skin products where you will put the patch. 

Also do not use them on or near a patch you are already wearing.  
• If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days 

before sticking the patch there.  
• If the edges of the patch lift, the patch may be taped down with adhesive medical tape. 
 
If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual 
time. 
 
• Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, 

heating pads or hot-water bottles. This is because the medicine may be released faster. If you 
think that too much heat has been applied, contact your doctor or pharmacist. 

• Always check that the patch has not fallen off after activities such as bathing, showering or 
exercising. 

• If the patch has irritated your skin, keep that area protected from direct sunlight. This is 
because it may change the colour of the skin. 

 
How to use the patch 
• Each patch is packed in a separate sachet.  
• Before opening the sachet decide where you are going to stick this new patch and check you 

have removed any old patch. 
• Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the 

release liner. 
 



129 

1. 
To open the sachet, hold the sachet 
in both hands. 

 
2.  
Peel apart the foil. 

 
3. 
Open the sachet. 

 
4. 
Take the patch out of the sachet. 

 
5.  
The sticky side of the patch is 
covered by a transparent release 
liner.  
• Hold the patch in both hands 

with the release liner facing 
you.  

6. 
• Bend the patch in half.  
This makes the S-shaped break in 
the liner open up. 

 
7. 
• Peel off one side of the 

release liner. 
• Do not touch the sticky side 

of the patch with your 
fingers. 

 



130 

8. 
• Hold the other half of the 

rigid release liner. 
• Then put the sticky half of 

the patch onto your skin. 
• Press the sticky side of the 

patch firmly into place. 
 

9. 
Fold back the other half of the 
patch and remove the other side of 
the release liner. 

 
10. 
• Press the patch down firmly 

with the palm of your hand.  
• Keep it pressed for about 

30 seconds.  
This makes sure the patch is 
touching the skin and the edges 
stick down well. 

 

 

11. 
Wash your hands with soap and 
water straight after handling the 
patch. 

 

 
How to take off a used patch 
• Slowly and carefully peel off the used patch. 
• Gently wash the area with warm water and mild soap. This will remove any stickiness that stays 

on your skin. You can also use a little baby oil to remove any stickiness that will not wash off. 
• Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate 

your skin. 
 
If you use more Leganto than you should 
Using higher doses of Leganto than your doctor has prescribed may cause side effects such as feeling 
sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real 
(hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.  
In such cases, contact your doctor or hospital straight away. They will tell you what to do 
 
If you forget to change the patch at your usual time 
• If you have forgotten to change the patch at your usual time, change it as soon as you remember. 

Take off the old patch and use a new one.  
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as 

soon as you remember.  
 
In both cases, use a new patch at the usual time on the following day. Do not use a double dose to 
make up for a forgotten dose. 
 
If you stop using Leganto 
Do not stop using Leganto without talking to your doctor. A sudden stop could lead to a medical 
condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: 
loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate 
(tachycardia), confusion, low level of consciousness (such as a coma).  



131 

 
If your doctor says you should stop Leganto,the daily dose should be lowered gradually: 
• Restless Legs Syndrome – lowered by 1 mg every other day. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your 
doctor or pharmacist if you notice any side effects. 
 
Side effects more likely at the start of treatment  
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or 
moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are 
worried about them. 
 
Skin problems caused by the patch 
• You may get redness and itching on the skin where the patch has been – these reactions are 

usually mild or moderate.  
• The reactions normally go away after a few hours – once you remove the patch. 
• Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. 

Also do this if it spreads outside the area of skin that was covered by the patch. 
• Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused 

by the patch.  
• To help avoid the skin reactions, you should put the patch on a different area of skin every day, 

and only use the same area again after 14 days. 
 

Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Tell your doctor if you get any changes in behaviour, thinking or both, that are listed below. 
They will discuss ways of managing or reducing symptoms.  
 
You may find it helpful to also tell a member of your family or carer that you are using this medicine 
and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if 
they are worried about any changes in your behaviour. Leganto can cause unusual urges or cravings 
which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself 
or others.  
 
These may include: 
• strong impulse to gamble too much – even if this seriously affects you or your family 
• altered or increased sexual interest and behaviour which causes significant concern to you or 

others – for example, an increased sex drive 
• uncontrolled shopping or spending too much 
• binge eating (eating large amounts of food in a short period of time) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger). 
 
Leganto may cause other behaviours and abnormal thinking. These may include: 
• abnormal thoughts about reality 
• delusions and hallucinations (seeing or hearing things that are not real) 
• confusion 
• disorientation 
• aggressive behaviour 



132 

• agitation 
• delirium.  
 
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. 
They will discuss ways of managing or reducing symptoms.  
 
Allergic reactions 
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, 
tongue or lips. 
 
Side effects when using Leganto for Restless Legs Syndrome 
Tell your doctor or pharmacist if you notice any of the following side effects: 
 
Very common: may affect more than 1 in 10 people 
• headache 
• feeling sick (nausea) 
• feeling weak (fatigue) 
• skin irritations under the patch such as redness and itching 
 
Common: may affect up to 1 in 10 people  
• itching 
• feeling irritable 
• allergic reaction 
• increased sex drive 
• high blood pressure 
• vomiting, heartburn 
• swelling of legs and feet  
• feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, 

having unusual dreams  
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, 

repetitive meaningless actions, uncontrolled shopping or spending too much 
binge eating (eating large amount of food in a short period of time) or compulsive eating (eating more 
food than normal and more than needed to satisfy hunger) 
 
Uncommon: may affect up to 1 in 100 people  
• feeling agitated 
• feeling dizzy when standing up because of a fall in blood pressure 
 
Rare: may affect up to 1 in 1,000 people 
• being aggressive 
• disorientation 
 
Not known: it is not known how often these happen 
• craving large doses of medicines like Leganto – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto 
• seeing or hearing things that are not real (hallucinations) 
• nightmares 
• paranoia 
• confusion 
• psychotic disorders 
• delusion 
• delirium 
• feeling dizzy 
• loss of consciousness, involuntary movements (dyskinesia) 
• involuntary muscle spasms (convulsion) 



133 

• blurry vision 
• visual disturbances such as seeing colours or lights 
• vertigo (sensation of whirling motion) 
• feeling of heartbeat (palpitation) 
• abnormal heart rhythm 
• low blood pressure 
• hiccups 
• constipation, dry mouth 
• stomach discomfort and pain 
• diarrhoea 
• redness, increased sweating 
• generalised itching, skin irritation 
• generalised rash 
• unable to achieve or maintain an erection 
• weight loss, weight increase 
• increased or abnormal liver function test results 
• increased heart rate 
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal 

muscles) 
• falling 
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of 

the muscles and may lead to kidney problems) 
 
Talk to your doctor or pharmacist if you notice any of the side effects listed above. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Leganto 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and box. 
 
Do not store above 30°C. 
 
What to do with the used and unused patches 
• Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. 

Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then 
throw it away safely, out of the reach of children. 

 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 

how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Leganto contains 
The active substance is rotigotine.  
• 1 mg/24 h: 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


134 

Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm2 contains 2.25 mg of 
rotigotine. 

 
• 3 mg/24 h: 

Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm2 contains 6.75 mg of 
rotigotine. 

 
The other ingredients are: 
• Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium 

metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307). 
• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium 

dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, 
pigment yellow 95, pigment black 7). 

• Release liner: Transparent fluoropolymer coated polyester film. 
 
What Leganto looks like and contents of the pack 
Leganto is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges. 
The outside is tan-coloured and is imprinted with Leganto 1 mg/24 h or 3 mg/24 h. 
 
Leganto is available in the following pack-sizes: 
Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually 
sealed in sachets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
Manufacturer 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l’Alleud 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: +359-(0)2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: +420-221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: +36-(1) 391 0060 
 



135 

Danmark 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: +356-21 37 64 36 
 

Deutschland 
Bayer Vital GmbH 
Tel: +49-(0)214-30 513 48 
 

Nederland 
UCB Pharma B.V. 
Tel.: +31-(0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: +30-2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: +43-(0)1 291 80 00 

España 
UCB Pharma S.A. 
Tel: +34-91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel.: +48-22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: +33-(0)1 47 29 44 35 

Portugal 
BIAL-Portela & Cª, S.A. 
Tel: +351-22 986 61 00 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385-(0)1 230 34 46 
 

România 
UCB Pharma România S.R.L. 
Tel: +40-21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: +353-(0)1 46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: +386-1 589 69 00 
 

Ísland 
Vistor hf. 
Sími: +354-535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: +421-(0)2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: +39-02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: +358-92 514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: +357-22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: +46-(0)40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel : +44-(0)1753 534 655 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


136 

 
Package leaflet: Information for the user 

 
Leganto 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 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: 
• Parkinson’s disease – Leganto 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 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 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. 
 



137 

If any of the above apply to you, do not use Leganto. If you are not sure about this, talk to your doctor, 
pharmacist or nurse first. 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Leganto. This is because: 
• your blood pressure needs checking regularly while using Leganto, especially at the start of the 

treatment. Leganto may affect your blood pressure. 
• your eyes need checking regularly while using Leganto. If you notice any problems with your 

eyesight between checks, talk to your doctor straight away. 
• if you have serious liver problems, your doctor may need to change the dose. If your liver 

problems get worse during treatment, talk to your doctor straight away. 
• you may get skin problems caused by the patch – see ‘Skin problems caused by the patch’ in 

section 4. 
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in 

section 2. 
• your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and 

involve other limbs. If you experience such symptoms either before or after beginning treatment 
with Leganto, contact your doctor as your treatment may need to be adjusted. 

 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Leganto can cause side effects that change your behaviour (how you act). You may find it helpful to 
tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. 
This is so that your family or carer can tell you, or your doctor, if they are worried about any changes 
in your behaviour. 
 
These include:  
• unusual urges or cravings which you cannot resist and that could harm yourself or others – the 

symptoms are mainly seen in patients with Parkinson’s disease 
• abnormal thinking or behaviour – most of the symptoms occur more frequently in patients with 

Parkinson’s disease. 
 
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information. 
 
Children and adolescents 
Do not give this medicine to children below 18 years of age because it is not known if it is safe or 
effective in this age group. 
 
Other medicines and Leganto 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. 
 
If you are treated with Leganto and levodopa at the same time, some side effects may get more 
serious. This includes seeing or hearing things that are not real (hallucinations), movements you 
cannot control related to Parkinson’s disease (‘dyskinesia’), and swelling of legs and feet. 
 
Do not take the following medicines while using Leganto – because they may decrease its effect  
• ‘anti-psychotic’ medicines – used to treat certain mental illnesses 
• metoclopramide – used to treat nausea (feeling sick) and vomiting.  
 
Talk to your doctor before using Leganto if you are taking: 
• sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 



138 

• medicines that lower blood pressure. Leganto may decrease blood pressure when you stand up – 
this effect may be worsened by the medicines used to lower blood pressure. 

 
Your doctor will let you know if it is safe to keep taking these medicines while using Leganto. 
 
Leganto with food, drink and alcohol 
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way 
this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to 
drink alcohol while using Leganto. 
 
Pregnancy and breast-feeding 
Do not use Leganto if you are pregnant. This is because the effects of rotigotine on pregnancy and the 
unborn baby are not known.  
 
Do not breast-feed during treatment with Leganto.This is because rotigotine may pass into your breast 
milk and affect your baby. It is also likely to lower the amount of milk you produce. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine. 
 
Driving and using machines 
Leganto may make you feel very sleepy and you may fall asleep very suddenly. If this happens, do not 
drive. In isolated cases, people have fallen asleep while driving and this has caused accidents. 
 
Also do not use tools or machines if you feel very sleepy – or do anything else which may put others 
or yourself at risk of serious injury. 
 
Leganto contains sodium metabisulphite (E223) 
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and 
bronchospasm (breathing distress caused by narrowing of the airways). 
 
 
3. How to use Leganto 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Which strength patches to use 
The dose of Leganto will depend on your illness – see below. 
 
Leganto is available in different strength patches which release the medicine over 24 hours. The 
strengths are 1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h. The patches of 1 
mg/24 h and 3 mg/24 h are used for the treatment of Restless Leg Syndrome, while the patches of  
4 mg/24 h, 6 mg/24 h and 8 mg/24 h are used for the treatment of Parkinson’s disease. The patches of 
2 mg/24 h are used for the treatment of Parkinson´s disease and Restless Leg Syndrome. 
• You may have to use more than one patch to reach your dose, as prescribed by your doctor. 
• For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available 

strengths), multiple patches must be applied to achieve the final dose. For example the daily 
dose of 10 mg may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.  

• The patches should not be cut into pieces.  
 
Treatment of Parkinson’s disease 
Patients not taking levodopa – early stage of Parkinson’s disease 
• Your starting daily dose will be one 2 mg/24 h patch each day.  
• From the second week your daily dose may be increased by 2 mg each week – until you get to 

the right maintenance dose for you.  



139 

• For most patients, the right dose is between 6 mg and 8 mg each day. This is normally reached 
within 3 to 4 weeks. 

• The maximum dose is 8 mg each day. 
 

Patients taking levodopa – advanced stage of Parkinson’s disease 
• Your starting daily dose will be one 4 mg/24 h patch each day.  
• From the second week your daily dose will be increased by 2 mg each week – until you get to 

the right maintenance dose for you.  
• For most patients, the right dose is between 8 mg and 16 mg each day. This is normally reached 

within 3 to 7 weeks. 
• The maximum dose is 16 mg each day. 

 
Treatment of Restless Legs Syndrome 
• Your starting dose will be one 1 mg/24 h patch each day.  
• From the second week, your daily dose may be increased by 1 mg each week – until you get to 

the right maintenance dose for you. This is when you and your doctor agree that the symptoms 
are being controlled well enough and the side effects of the medicines are acceptable. 

• The maximum dose is 3 mg per day. 
 
If you have to stop taking this medicine, see ‘If you stop using Leganto’ in section 3. 
 
How to use the Leganto patches: 
Leganto is a patch that is put on the skin. 
• Make sure that you take the old patch off before putting on a new one. 
• Stick the new patch on a different area of the skin each day.  
• Leave the patch on your skin for 24 hours, then take it off and put on a new one.  
• Change the patches at about the same time every day. 
• Do not cut the Leganto patches into pieces. 
 
Where to stick the patch 
Put the sticky side of the patch onto clean, dry, 
healthy skin on the following areas as shown in grey on 
the pictures opposite:  
• Shoulder or upper arm. 
• Belly. 
• Flank (your side, between the ribs 

and hips). 
• Thigh or hip. 

  
 
To avoid skin irritation  
• Stick the patch onto a different area of skin each day. For 

example, put it on the right side of your body one day, then 
on the left side of your body the next day. Or on your upper 
body one day, then on your lower body the day after that.  

• Do not stick Leganto on the same area of skin twice 
within 14 days. 

• Do not stick the patch on broken or damaged skin – or on 
skin that is red or irritated. 

 

 
If you still get problems with your skin because of the patch, please see ‘Skin problems caused by 
the patch’ in section 4 for more information. 
 
To prevent the patch becoming loose or falling off 
• Do not put the patch in an area where it can be rubbed by tight clothing. 



140 

• Do not use creams, oils, lotions, powders or other skin products where you will put the patch. 
Also do not use them on or near a patch you are already wearing.  

• If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days 
before sticking the patch there. 

• If the edges of the patch lift, the patch may be taped down with adhesive medical tape. 
 
If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual 
time. 
 
• Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, 

heating pads or hot-water bottles. This is because the medicine may be released faster. If you 
think that too much heat has been applied, contact your doctor or pharmacist. 

• Always check that the patch has not fallen off after activities such as bathing, showering or 
exercising. 

• If the patch has irritated your skin, keep that area protected from direct sunlight. This is 
because it may change the colour of the skin. 

 
How to use the patch 
• Each patch is packed in a separate sachet.  
• Before opening the sachet decide where you are going to stick this new patch and check you 

have removed any old patch. 
• Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the 

release liner. 
 
1. 
To open the sachet, hold the 
sachet in both hands.  

 
2.  
Peel apart the foil. 

 
3. 
Open the sachet. 

 
4. 
Take the patch out of the sachet. 

 



141 

5.  
The sticky side of the patch is 
covered by a transparent release 
liner.  
• Hold the patch in both hands 

with the release liner facing 
you.  

6. 
• Bend the patch in half.  
This makes the S-shaped break in 
the liner open up. 

 
7. 
• Peel off one side of the 

release liner.  
• Do not touch the sticky 

side of the patch with your 
fingers. 

 
8. 
• Hold the other half of the 

rigid release liner.  
• Then put the sticky half of 

the patch onto your skin.  
• Press the sticky side of the 

patch firmly into place. 
 

9. 
Fold back the other half of the 
patch and remove the other side 
of the release liner. 

 
10. 
• Press the patch down 

firmly with the palm of 
your hand.  

• Keep it pressed for about 
30 seconds.  

This makes sure the patch is 
touching the skin and the edges 
stick down well. 

 

11. 
Wash your hands with soap and 
water straight after handling the 
patch. 

 

 
How to take off a used patch 
• Slowly and carefully peel off the used patch. 
• Gently wash the area with warm water and mild soap. This will remove any stickiness that stays 

on your skin. You can also use a little baby oil to remove any stickiness that will not wash off. 



142 

• Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate 
your skin. 

 
If you use more Leganto than you should 
Using higher doses of Leganto than your doctor has prescribed may cause side effects such as feeling 
sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real 
(hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.  
In such cases, contact your doctor or hospital straight away. They will tell you what to do. 
 
If you forget to change the patch at your usual time 
• If you have forgotten to change the patch at your usual time, change it as soon as you remember. 

Take off the old patch and use a new one.  
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as 

soon as you remember.  
 
In both cases, use a new patch at the usual time on the following day. Do not use a double dose to 
make up for a forgotten dose. 
 
If you stop using Leganto 
Do not stop using Leganto without talking to your doctor. A sudden stop could lead to a medical 
condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: 
loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate 
(tachycardia), confusion, low level of consciousness (such as a coma).  
 
If your doctor says you should stop Leganto, the daily dose should be lowered gradually: 
• Parkinson’s disease – lowered by 2 mg every other day. 
• Restless Legs Syndrome – lowered by 1 mg every other day. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your 
doctor, pharmacist or nurse if you notice any side effects. 
 
Side effects more likely at the start of treatment  
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or 
moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are 
worried about them. 
 
Skin problems caused by the patch 
• You may get redness and itching on the skin where the patch has been – these reactions are 

usually mild or moderate. 
• The reactions normally go away after a few hours – once you remove the patch. 
• Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. 

Also do this if it spreads outside the area of skin that was covered by the patch. 
• Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused 

by the patch.  
• To help avoid the skin reactions, you should put the patch on a different area of skin every day, 

and only use the same area again after 14 days. 
 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 



143 

Changes in behaviour and abnormal thinking 
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. 
They will discuss ways of managing or reducing symptoms.  
 
You may find it helpful to also tell a member of your family or carer that you are using this medicine 
and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if 
they are worried about any changes in your behaviour. Leganto can cause unusual urges or cravings 
which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself 
or others – the symptoms are mainly seen in patients with Parkinson’s disease.  
 
These may include: 
• strong impulse to gamble too much – even if this seriously affects you or your family 
• altered or increased sexual interest and behaviour which causes significant concern to you or 

others – for example, an increased sex drive 
• uncontrolled shopping or spending too much 
• binge eating (eating large amounts of food in a short period of time) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger). 
 
Leganto may cause other behaviours and abnormal thinking. These may include: 
• abnormal thoughts about reality 
• delusions and hallucinations (seeing or hearing things that are not real) 
• confusion 
• disorientation 
• aggressive behaviour 
• agitation 
• delirium.  
 
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed above. 
They will discuss ways of managing or reducing symptoms.  
 
Allergic reactions 
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, 
tongue or lips. 
 
Side effects when using Leganto for Parkinson’s disease 
Tell your doctor, pharmacist or nurse if you get any of the following side effects: 
 
Very common: may affect more than 1 in 10 people  
• headache 
• feeling sleepy or dizzy 
• feeling sick (nausea), vomiting 
• skin reactions under the patch such as redness and itching 
 
Common: may affect up to 1 in 10 people  
• falling 
• hiccups  
• weight loss 
• swelling of legs and feet  
• feeling weak (fatigue), feeling tired  
• feeling of heartbeat (palpitation) 
• constipation, dry mouth, heartburn 
• redness, increased sweating, itching 
• vertigo (sensation of whirling motion) 
• seeing or hearing things that are not real (hallucinations) 
• low blood pressure when standing up, high blood pressure  



144 

• difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams  
• movements you cannot control related to Parkinson’s disease (dyskinesia) 
• fainting, feeling dizzy when standing up because of fall in blood pressure 
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, 

repetitive meaningless actions, uncontrolled shopping or spending too much 
• binge eating (eating large amount of food in a short period of time), compulsive eating (eating 

more food than normal and more than needed to satisfy hunger) 
 
Uncommon: may affect up to 1 in 100 people  
• blurred vision 
• weight increase 
• allergic reaction 
• low blood pressure 
• increased heart rate 
• increased sex drive 
• abnormal heart beat  
• stomach discomfort and pain 
• generalised itching, skin irritation 
• falling asleep suddenly without warning 
• unable to achieve or maintain an erection 
• feeling agitated, disorientated, confused or paranoid 
• increased or abnormal liver test results 
• sight problems such as seeing colours or lights 
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal 

muscles). 
 
Rare: may affect up to 1 in 1,000 people  
• delusion 
• delirium 
• feeling irritable 
• being aggressive  
• psychotic disorders  
• rash over larger parts of the body 
• involuntary muscle spasms (convulsion) 
 
Not known: it is not known how often these happen 
• craving large doses of medicines like Leganto – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto. 
• diarrhoea 
• dropped head syndrome 
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of 

the muscles and may lead to kidney problems) 
 
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. 
 
Side effects when using Leganto for Restless Legs Syndrome 
Tell your doctor or pharmacist if you notice any of the following side effects: 
 
Very common: may affect more than 1 in 10 people  
• headache 
• feeling sick (nausea) 
• feeling weak (fatigue) 
• skin irritations under the patch such as redness and itching 
 



145 

Common: may affect up to 1 in 10 people  
• itching 
• feeling irritable 
• allergic reaction 
• increased sex drive 
• high blood pressure 
• vomiting, heartburn 
• swelling of legs and feet  
• feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, 

having unusual dreams  
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, 

repetitive meaningless actions, uncontrolled shopping or spending too much 
• binge eating (eating large amount of food in a short period of time) or compulsive eating (eating 

more food than normal and more than needed to satisfy hunger) 
 
Uncommon: may affect up to 1 in 100 people  
• feeling agitated 
• feeling dizzy when standing up because of a fall in blood pressure 
 
Rare: may affect up to 1 in 1,000 people 
• being aggressive 
• disorientation 
 
Not known: it is not known how often these happen 
• craving large doses of medicines like Leganto – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto 
• seeing or hearing things that are not real (hallucinations) 
• nightmares 
• paranoia 
• confusion 
• psychotic disorders 
• delusion 
• delirium 
• feeling dizzy 
• loss of consciousness, involuntary movements (dyskinesia) 
• involuntary muscle spasms (convulsion) 
• blurry vision 
• visual disturbances such as seeing colours or lights 
• vertigo (sensation of whirling motion) 
• feeling of heartbeat (palpitation) 
• abnormal heart rhythm 
• low blood pressure 
• hiccups 
• constipation, dry mouth 
• stomach discomfort and pain 
• diarrhoea 
• redness, increased sweating 
• generalised itching, skin irritation 
• generalised rash 
• unable to achieve or maintain an erection 
• weight loss, weight increase 
• increased or abnormal liver function test results 
• increased heart rate 



146 

• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal 
muscles) 

• falling 
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of 

the muscles and may lead to kidney problems) 
 

Talk to your doctor or pharmacist if you notice any of the side effects listed above. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Leganto 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and box. 
 
Do not store above 30°C. 
 
What to do with the used and unused patches 
• Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. 

Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then 
throw it away safely, out of the reach of children. 

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Leganto contains 
The active substance is rotigotine. 
• Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm2 contains 4.5 mg of 

rotigotine. 
 
The other ingredients are: 
• Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium 

metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307). 
• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium 

dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, 
pigment yellow 95, pigment black 7). 

• Release liner: Transparent fluoropolymer coated polyester film. 
 
What Leganto looks like and contents of the pack 
Leganto is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges. 
The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h. 
 
Leganto is available in the following pack-sizes: 
Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually 
sealed in sachets. 
 
Not all pack sizes may be marketed. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


147 

Marketing Authorisation Holder  
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
Manufacturer 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l’Alleud 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: +359-(0)2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: +420-221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: +36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: +356-21 37 64 36 
 

Deutschland 
Bayer Vital GmbH 
Tel: +49-(0)214-30 513 48 
 

Nederland 
UCB Pharma B.V. 
Tel.: +31-(0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: +30-2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: +43-(0)1 291 80 00 

España 
UCB Pharma S.A. 
Tel: +34-91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel.: +48-22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: +33-(0)1 47 29 44 35 

Portugal 
BIAL-Portela & Cª, S.A. 
Tel: +351-22 986 61 00 
 



148 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385-(0)1 230 34 46 
 

România 
UCB Pharma România S.R.L. 
Tel: +40-21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: +353-(0)1 46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: +386-1 589 69 00 
 

Ísland 
Vistor hf. 
Sími: +354-535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: +421-(0)2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: +39-02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: +358-92 514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: +357-22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: +46-(0)40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel : +44-(0)1753 534 655 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


149 

Package leaflet: Information for the user 
 

Leganto 4 mg/24 h transdermal patch 
Leganto 6 mg/24 h transdermal patch 
Leganto 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 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:  
• Parkinson’s disease – Leganto can be used on its own or with another medicine called 

levodopa. 
 
 
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 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 Leganto. If you are not sure about this, talk to your doctor, 
pharmacist or nurse first.  
 



150 

Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Leganto. This is because: 
• your blood pressure needs checking regularly while using Leganto, especially at the start of the 

treatment. Leganto may affect your blood pressure. 
• your eyes need checking regularly while using Leganto. If you notice any problems with your 

eyesight between checks, talk to your doctor straight away. 
• if you have serious liver problems, your doctor may need to change the dose. If your liver 

problems get worse during treatment, talk to your doctor straight away. 
• you may get skin problems caused by the patch – see ‘Skin problems caused by the patch’ in 

section 4. 
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in 

section 2. 
 

If you experience these symptoms after beginning treatment with Leganto, contact your doctor. 
 

Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Leganto can cause side effects that change your behaviour (how you act). You may find it helpful to 
tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. 
This is so that your family or carer can tell you, or your doctor, if they are worried about any changes 
in your behaviour. 
 
These include:  
• unusual urges or cravings which you cannot resist and that could harm yourself or others  
• abnormal thinking or behaviour. 
 
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information. 
 
Children and adolescents 
Do not give this medicine to children below 18 years of age because it is not known if it is safe or 
effective in this age group. 
 
Other medicines and Leganto 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. 
 
If you are treated with Leganto and levodopa at the same time, some side effects may get more 
serious. This includes seeing or hearing things that are not real (hallucinations), movements you 
cannot control related to Parkinson’s disease (‘dyskinesia’), and swelling of legs and feet. 
 
Do not take the following medicines while using Leganto – because they may decrease its effect  
• ‘anti-psychotic’ medicines – used to treat certain mental illnesses  
• metoclopramide – used to treat nausea (feeling sick) and vomiting.  
 
Talk to your doctor before using Leganto if you are taking: 
• sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 
• medicines that lower blood pressure. Leganto may decrease blood pressure when you stand up – 

this effect may be worsened by the medicines used to lower blood pressure. 
 
Your doctor will let you know if it is safe to keep taking these medicines while using Leganto. 
 



151 

Leganto with food, drink and alcohol 
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way 
this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to 
drink alcohol while using Leganto. 
 
Pregnancy and breast-feeding 
Do not use Leganto if you are pregnant. This is because the effects of rotigotine on pregnancy and the 
unborn baby are not known.  
 
Do not breast-feed during treatment with Leganto. This is because rotigotine may pass into your breast 
milk and affect your baby. It is also likely to lower the amount of milk you produce. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine. 
 
Driving and using machines 
Leganto may make you feel very sleepy, and you may fall asleep very suddenly. If this happens, do not 
drive. In isolated cases people have fallen asleep while driving and this has caused accidents. 
 
Also do not use tools or machines if you feel very sleepy – or do anything else which may put others 
or yourself at risk of serious injury. 
 
Leganto contains sodium metabisulphite (E223) 
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and 
bronchospasm (breathing distress caused by narrowing of the airways). 
 
 
3. How to use Leganto 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Which strength patches to use 
The dose of Leganto will depend on your illness – see below. 
 
Leganto is available in different strength patches which release the medicine over 24 hours. The 
strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson’s disease.  
 
• You may have to use more than one patch to reach your dose, as prescribed by your doctor. 
• For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available 

strengths), multiple patches must be applied to achieve the final dose. For example a daily dose 
of 10 mg/24 h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h. 

• The patches should not be cut into pieces.  
 
Treatment of Parkinson’s disease 
Patients not taking levodopa – early stage of Parkinson’s disease 
• Your starting daily dose will be one 2 mg/24 h patch each day.  
• From the second week your daily dose may be increased by 2 mg each week – until you get to 

the right maintenance dose for you.  
• For most patients, the right dose is between 6 mg and 8 mg each day. This is normally reached 

within 3 to 4 weeks. 
• The maximum dose is 8 mg each day. 

 
Patients taking levodopa – advanced stage of Parkinson’s disease 
• Your starting daily dose will be one 4 mg/24 h patch each day.  
• From the second week your daily dose will be increased by 2 mg each week – until you get to 

the right maintenance dose for you.  



152 

• For most patients, the right dose is between 8 mg and 16 mg each day. This is normally reached 
within 3 to 7 weeks. 

• The maximum dose is 16 mg each day. 
 
If you have to stop taking this medicine, see ‘If you stop using Leganto’ in section 3. 
 
How to use the Leganto patches: 
Leganto is a patch that is put on the skin. 
• Make sure that you take the old patch off before putting on a new one. 
• Stick the new patch on a different area of the skin each day.  
• Leave the patch on your skin for 24 hours, then take it off and put on a new one.  
• Change the patches at about the same time every day. 
• Do not cut the Leganto patches into pieces. 
 
Where to stick the patch 
Put the sticky side of the patch onto clean, dry, 
healthy skin on the following areas as shown in grey on 
the pictures opposite:  
• Shoulder or upper arm. 
• Belly. 
• Flank (your side, between the ribs 

and hips). 
• Thigh or hip. 

 
 

 
To avoid skin irritation  
• Stick the patch onto a different area of skin each day. For 

example, put it on the right side of your body one day, then 
on the left side of your body the next day. Or on your upper 
body one day, then on your lower body the day after that.  

• Do not stick Leganto on the same area of skin twice 
within 14 days. 

• Do not stick the patch on broken or damaged skin – or on 
skin that is red or irritated. 

 

 

If you still get problems with your skin because of the patch, please see Skin problems caused by the 
patch’ in section 4 for more information. 
 
To prevent the patch becoming loose or falling off 
• Do not put the patch in an area where it can be rubbed by tight clothing. 
• Do not use creams, oils, lotions, powders or other skin products where you will put the patch. 

Also do not use them on or near a patch you are already wearing.  
• If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days 

before sticking the patch there. 
• If the edges of the patch lift, the patch may be taped down with adhesive medical tape. 
 
If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual 
time. 
 
• Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, 

heating pads or hot-water bottles. This is because the medicine may be released faster. If you 
think that too much heat has been applied, contact your doctor or pharmacist. 

• Always check that the patch has not fallen off after activities such as bathing, showering or 
exercising. 

• If the patch has irritated your skin, keep that area protected from direct sunlight. This is 
because it may change the colour of the skin. 



153 

 
How to use the patch 
• Each patch is packed in a separate sachet.  
• Before opening the sachet decide where you are going to stick this new patch and check you 

have removed any old patch. 
• Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the 

release liner. 
 
1. 
To open the sachet, hold the 
sachet in both hands.  

 
2.  
Peel apart the foil. 

 
3. 
Open the sachet. 

 
4. 
Take the patch out of the 
sachet. 

 
5.  
The sticky side of the patch is 
covered by a transparent 
release liner.  
• Hold the patch in both 

hands with the release 
liner facing you.  

6. 
• Bend the patch in half.  
This makes the S-shaped 
break in the liner open up. 

 



154 

7. 
• Peel off one side of the 

release liner.  
• Do not touch the sticky 

side of the patch with 
your fingers. 

 
8. 
• Hold the other half of 

the rigid release liner.  
• Then put the sticky half 

of the patch onto your 
skin.  

• Press the sticky side of 
the patch firmly into 
place. 

 

9. 
Fold back the other half of the 
patch and remove the other 
side of the release liner. 

 
10. 
• Press the patch down 

firmly with the palm of 
your hand.  

• Keep it pressed for 
about 30 seconds.  

This makes sure the patch is 
touching the skin and the 
edges stick down well. 

 

11. 
Wash your hands with soap 
and water straight after 
handling the patch. 

 

 
How to take off a used patch 
• Slowly and carefully peel off the used patch. 
• Gently wash the area with warm water and mild soap. This will remove any stickiness that stays 

on your skin. You can also use a little baby oil to remove any stickiness that will not wash off. 
• Do not use alcohol or other dissolving liquids such as nail polish remover. These may irritate 

your skin. 
 
If you use more Leganto than you should 
Using higher doses of Leganto than your doctor has prescribed may cause side effects such as feeling 
sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real 
(hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions. In 
such cases, contact your doctor or hospital straight away. They will tell you what to do. 
 
If you forget to change the patch at your usual time 
• If you have forgotten to change the patch at your usual time, change it as soon as you remember. 

Take off the old patch and use a new one.  
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as 

soon as you remember. 
 



155 

In both cases, use a new patch at the usual time on the following day. Do not use a double dose to 
make up for a forgotten dose. 
 
If you stop using Leganto 
Do not stop using Leganto without talking to your doctor. A sudden stop could lead to a medical 
condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: 
loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate 
(tachycardia), confusion, low level of consciousness (such as a coma).  
 
If your doctor says you should stop Leganto, the daily dose should be lowered gradually: 
• Parkinson’s disease – lowered by 2 mg every other day. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your 
doctor or pharmacist if you notice any side effects. 
 
Side effects more likely at the start of treatment 
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or 
moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are 
worried about them. 
 
Skin problems caused by the patch 
• You may get redness and itching on the skin where the patch has been – these reactions are 

usually mild or moderate. 
• The reactions normally go away after a few hours – once you remove the patch. 
• Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. 

Also do this if it spreads outside the area of skin that was covered by the patch. 
• Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused 

by the patch.  
• To help avoid the skin reactions, you should put the patch on a different area of skin every day, 

and only use the same area again after 14 days. 
 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. 
They will discuss ways of managing or reducing symptoms.  
 
You may find it helpful to also tell a member of your family or carer that you are using this medicine 
and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if 
they are worried about any changes in your behaviour. Leganto can cause unusual urges or cravings 
which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself 
or others.  
 
These may include: 
• strong impulse to gamble too much – even if this seriously affects you or your family 
• altered or increased sexual interest and behaviour which causes significant concern to you or 

others – for example, an increased sex drive 
• uncontrolled shopping or spending too much 



156 

• binge eating (eating large amounts of food in a short period of time) or compulsive eating 
(eating more food than normal and more than is needed to satisfy your hunger). 

 
Leganto may cause other behaviours and abnormal thinking. These may include: 
• abnormal thoughts about reality 
• delusions and hallucinations (seeing or hearing things that are not real) 
• confusion 
• disorientation 
• aggressive behaviour 
• agitation 
• delirium.  
 
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. 
They will discuss ways of managing or reducing symptoms.  
 
Allergic reactions 
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, 
tongue or lips. 
 
Side effects when using Leganto for Parkinson’s disease 
Tell your doctor, pharmacist or nurse if you get any of the following side effects: 
 
Very common: may affect more than 1 in 10 people  
• headache 
• feeling sleepy or dizzy 
• feeling sick (nausea), vomiting 
• skin reactions under the patch such as redness and itching 
 
Common: may affect up to 1 in 10 people  
• falling 
• hiccups  
• weight loss 
• swelling of legs and feet  
• feeling weak (fatigue), feeling tired  
• feeling of heartbeat (palpitation) 
• constipation, dry mouth, heartburn 
• redness, increased sweating, itching 
• vertigo (sensation of whirling motion) 
• seeing or hearing things that are not real (hallucinations) 
• low blood pressure when standing up, high blood pressure  
• difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams  
• movements you cannot control related to Parkinson’s disease (dyskinesia) 
• fainting, feeling dizzy when standing up because of fall in blood pressure 
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, 

repetitive meaningless actions, uncontrolled shopping or spending too much 
• binge eating (eating large amount of food in a short period of time), compulsive eating (eating 

more food than normal and more than needed to satisfy hunger) 
 
Uncommon: may affect up to 1 in 100 people  
• blurred vision 
• weight increase 
• allergic reaction 
• low blood pressure 
• increased heart rate 
• increased sex drive 



157 

• abnormal heart beat  
• stomach discomfort and pain 
• generalised itching, skin irritation 
• falling asleep suddenly without warning 
• unable to achieve or maintain an erection 
• feeling agitated, disorientated, confused or paranoid 
• increased or abnormal liver test results 
• sight problems such as seeing colours or lights 
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal 

muscles). 
 
Rare: may affect up to 1 in 1,000 people  
• delusion 
• delirium 
• feeling irritable 
• being aggressive  
• psychotic disorders  
• rash over larger parts of the body 
• involuntary muscle spasms (convulsion) 
 
Not known: it is not known how often these happen 
• craving large doses of medicines like Leganto – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto. 
• diarrhoea 
• dropped head syndrome 
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of 

the muscles and may lead to kidney problems) 
 
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Leganto 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and box. 
 
Do not store above 30°C. 
 
What to do with the used and unused patches 
• Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. 

Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then 
throw it away safely, out of the reach of children. 

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


158 

6. Contents of the pack and other information 
 
What Leganto contains 
The active substance is rotigotine. 
• 4 mg/24 h: 

Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 20 cm2 contains 9.0 mg of 
rotigotine. 
 

• 6 mg/24 h: 
Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30 cm2 contains 13.5 mg of 
rotigotine. 
 

• 8 mg/24 h: 
Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 cm2 contains 18.0 mg of 
rotigotine. 

 
The other ingredients are: 
• Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium 

metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307). 
• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium 

dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, 
pigment yellow 95, pigment black 7). 

• Release liner: Transparent fluoropolymer coated polyester film. 
 
What Leganto looks like and contents of the pack 
Leganto is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges. 
The outside is tan-coloured and is imprinted with Leganto 4 mg/24 h Leganto 6 mg/24 h or Leganto 
8 mg/24 h. 
 
Leganto is available in the following pack-sizes: 
Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually 
sealed in sachets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
Manufacturer 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l’Alleud 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Suomija) 
 



159 

България 
Ю СИ БИ България ЕООД 
Teл.: +359-(0)2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: +420-221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: +36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: +356-21 37 64 36 
 

Deutschland 
Bayer Vital GmbH 
Tel: +49-(0)214-30 513 48 
 

Nederland 
UCB Pharma B.V. 
Tel.: +31-(0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: +30-2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: +43-(0)1 291 80 00 

España 
UCB Pharma S.A. 
Tel: +34-91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel.: +48-22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: +33-(0)1 47 29 44 35 

Portugal 
BIAL-Portela & Cª, S.A. 
Tel: +351-22 986 61 00 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385-(0)1 230 34 46 
 

România 
UCB Pharma România S.R.L. 
Tel: +40-21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: +353-(0)1 46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: +386-1 589 69 00 
 

Ísland 
Vistor hf. 
Sími: +354-535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: +421-(0)2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: +39-02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: +358-92 514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: +357-22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: +46-(0)40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel : +44-(0)1753 534 655 

 



160 

This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

  

http://www.ema.europa.eu/


161 

Package leaflet: Information for the user 
 

Leganto 2 mg/24 h 
Leganto 4 mg/24 h 
Leganto 6 mg/24 h 
Leganto 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 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:  
• Parkinson’s disease – Leganto can be used on its own or with another medicine called 

levodopa. 
 
 
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 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. 
 



162 

If any of the above apply to you, do not use Leganto. If you are not sure about this, talk to your doctor 
or pharmacist first. 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Leganto. This is because 
• your blood pressure needs checking regularly while using Leganto, especially at the start of the 

treatment. Leganto may affect your blood pressure. 
• your eyes need checking regularly while using Leganto. If you notice any problems with your 

eyesight between checks, talk to your doctor straight away. 
• if you have serious liver problems, your doctor may need to change the dose. If your liver 

problems get worse during treatment, talk to your doctor straight away. 
• you may get skin problems caused by the patch – see ‘Skin problems caused by the patch’ in 

section 4. 
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in 

section 2. 
 
If you experience these symptoms after beginning treatment with Leganto, contact your doctor. 
 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 
Changes in behaviour and abnormal thinking 
Leganto can cause side effects that change your behaviour (how you act). You may find it helpful to 
tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. 
This is so that your family or carer can tell you, or your doctor, if they are worried about any changes 
in your behaviour. 
 
These include:  
• unusual urges or cravings which you cannot resist and that could harm yourself or others 
• abnormal thinking or behaviour. 
 
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information. 
 
Children and adolescents 
Do not give this medicine to children below 18 years of age because it is not known if it is safe or 
effective in this age group. 
 
Other medicines and Leganto 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. 
 
If you are treated with Leganto and levodopa at the same time, some side effects may get more 
serious. This includes seeing or hearing things that are not real (hallucinations), movements you 
cannot control related to Parkinson’s disease (‘dyskinesia’), and swelling of legs and feet. 
 
Do not take the following medicines while using Leganto – because they may decrease its effect:  
• ‘anti-psychotic’ medicines – used to treat certain mental illnesses 
•  metoclopramide – used to treat nausea (feeling sick) and vomiting.  
 
Talk to your doctor before using Leganto if you are taking: 
• sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 
• medicines that lower blood pressure. Leganto may decrease blood pressure when you stand up – 

this effect may be worsened by the medicines used to lower blood pressure.  
 



163 

Your doctor will let you know if it is safe to keep taking these medicines while using Leganto. 
 
Leganto with food, drink and alcohol 
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way 
this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to 
drink alcohol while using Leganto. 
 
Pregnancy and breast-feeding 
Do not use Leganto if you are pregnant. This is because the effects of rotigotine on pregnancy and the 
unborn baby are not known.  
 
Do not breast-feed during treatment with Leganto. This is because rotigotine may pass into your breast 
milk and affect your baby. It is also likely to lower the amount of milk you produce. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine. 
 
Driving and using machines 
Leganto may make you feel very sleepy and you may fall asleep very suddenly. If this happens, do not 
drive. In isolated cases people have fallen asleep while driving and this has caused accidents. 
 
Also do not use tools or machines if you feel very sleepy – or do anything else which may put others 
or yourself at risk of serious injury. 
 
Leganto contains sodium metabisulphite (E223) 
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and 
bronchospasm (breathing distress caused by narrowing of the airways). 
 
 
3. How to use Leganto 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Which strength patches to use 
The dose of Lengato will depend on your illness – see below. 
  
Leganto is available in different strength patches which release the medicine over 24 hours. The 
strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson’s disease. 
You may have to use more than one patch to reach your dose, as prescribed by your doctor. 
 
The Leganto treatment initiation pack contains 4 different packages (one for each strength) with 
7 patches in each package. These packages are usually needed for the first four weeks of therapy, but 
depending on your response to Leganto, you may not need to use all of the dose packages included or 
you may need additional higher doses after week 4, which are not covered by this package.  
 
On the first day of treatment, start with Leganto 2 mg (package marked “Week 1”), and use one 
Leganto 2 mg transdermal patch daily. You should take Leganto 2 mg for 7 days 
(e.g. if you start on a Sunday, switch to the next dose on the following Sunday.).  
At the beginning of the second week, you should take Leganto 4 mg (package marked with 
“Week 2”). 
At the beginning of the third week, you should take Leganto 6 mg (package marked with “Week 3”). 
At the beginning of the fourth week, you should take Leganto 8 mg (package marked with “Week 4”). 
 
The right dose for you will depend on your needs. 
 



164 

4 mg of Leganto every day may be an effective dose for some patients. For most patients with early 
stage Parkinson’s disease, the right dose is reached within 3 or 4 weeks, at doses of 6 mg per day or 
8 mg per day respectively. The maximum dose is 8 mg per day. For most patients with advanced-stage 
Parkinson’s disease the right dose is reached within 3 to 7 weeks, at doses of 8 mg per day up to a 
maximum dose of 16 mg per day. For doses higher than 8 mg/24 h (doses prescribed by your doctor 
above the available strengths), multiple patches must be applied to achieve the final dose. For 
example, a daily dose of 14 mg may be reached by applying one patch of 6 mg/24 h and one patch of 8 
mg/24 h and likewise, a daily dose of 16 mg can be reached by applying two patches of 8 mg/24 h. 
 
If you have to stop taking this medicine, see ‘If you stop using Leganto’ in section 3. 
 
How to use the Leganto patches: 
Leganto is a patch that is put on the skin. 
• Make sure that you take the old patch off before putting on a new one. 
• Stick the new patch on a different area of the skin each day. 
• Leave the patch on your skin for 24 hours, then take it off and put on a new one.  
• Change the patch at about the same time every day. 
• Do not cut the Leganto patches into pieces. 
 
Where to stick the patch 
Put the sticky side of the patch onto clean, dry, 
healthy skin on the following areas as shown in grey on 
the pictures opposite:  
• Shoulder or upper arm. 
• Belly. 
• Flank (your side, between the ribs 

and hips). 
• Thigh or hip. 

  
 
To avoid skin irritation  
• Stick the patch onto a different area of skin each day. For 

example, put it on the right side of your body one day, then 
on the left side of your body the next day. Or on your upper 
body one day, then on your lower body the day after that.  

• Do not stick Leganto on the same area of skin twice 
within 14 days. 

• Do not stick the patch on broken or damaged skin – or on 
skin that is red or irritated. 

 

 

If you still get problems with your skin because of the patch, please see ‘Skin problems caused by 
the patch’ in section 4 for more information. 
 
To prevent the patch becoming loose or falling off 
• Do not put the patch in an area where it can be rubbed by tight clothing. 
• Do not use creams, oils, lotions, powders or other skin products where you will put the patch. 

Also do not use them on or near a patch you are already wearing.  
• If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days 

before sticking the patch there. 
• If the edges of the patch lift, the patch may be taped down with adhesive medical tape. 
 
If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual 
time. 
 



165 

• Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, 
heating pads or hot-water bottles. This is because the medicine may be released faster. If you 
think that too much heat has been applied, contact your doctor or pharmacist. 

• Always check that the patch has not fallen off after activities such as bathing, showering or 
exercising. 

• If the patch has irritated your skin, keep that area protected from direct sunlight. This is 
because it may change the colour of the skin. 

 
How to use the patch 
• Each patch is packed in a separate sachet.  
• Before opening the sachet decide where you are going to stick this new patch and check you 

have removed any old patch. 
• Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the 

release liner. 
 
1. 
To open the sachet, hold the 
sachet in both hands.  

 
2.  
Peel apart the foil. 

 
3. 
Open the sachet. 

 
4. 
Take the patch out of the sachet. 

 
5.  
The sticky side of the patch is 
covered by a transparent release 
liner.  
• Hold the patch in both 

hands with the release liner 
facing you.  



166 

6. 
• Bend the patch in half.  
This makes the S-shaped break 
in the liner open up. 

 
7. 
• Peel off one side of the 

release liner.  
• Do not touch the sticky 

side of the patch with 
your fingers. 

 
8. 
• Hold the other half of the 

rigid release liner.  
• Then put the sticky half 

of the patch onto your 
skin.  

• Press the sticky side of 
the patch firmly into 
place. 

 

9. 
Fold back the other half of the 
patch and remove the other side 
of the release liner. 

 
10. 
• Press the patch down 

firmly with the palm of 
your hand.  

• Keep it pressed for about 
30 seconds.  

This makes sure the patch is 
touching the skin and the edges 
stick down well. 

 

11. 
Wash your hands with soap and 
water straight after handling the 
patch. 

 

 
 
How to take off a used patch 
• Slowly and carefully peel off the used patch. 
• Gently wash the area with warm water and mild soap. This will remove any stickiness that stays 

on your skin. You can also use a little baby oil to remove any stickiness that will not wash off. 
• Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate 

your skin. 
 



167 

If you use more Leganto than you should 
Using higher doses of Leganto than your doctor has prescribed may cause side effects such as feeling 
sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real 
(hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.  
In such cases, contact your doctor or hospital straight away. They will tell you what to do. 
 
If you have used a different patch (e.g. Leganto 4 mg/24 h instead of Leganto 2 mg/24 h) than your 
doctor told you to, contact your doctor or hospital for advice immediately, and follow their advice on 
changes of patches. 
If you have any unpleasant reactions, contact your doctor. 
 
If you forget to change the patch at your usual time 
• If you have forgotten to change the patch at your usual time, change it as soon as you remember. 

Take off the old patch and use a new one.  
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as 

soon as you remember.  
 
In both cases, use a new patch at the usual time on the following day. Do not use a double dose to 
make up for a forgotten dose. 
 
If you stop using Leganto 
Do not stop using Leganto without talking to your doctor. A sudden stop could lead to a medical 
condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: 
loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate 
(tachycardia), confusion, low level of consciousness (such as a coma).  
 
If your doctor says you should stop Leganto, the daily dose of Leganto should be lowered gradually: 
• Parkinson’s disease – lowered by 2 mg every other day. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your 
doctor or pharmacist if you notice any side effects. 
 
Side effects more likely at the start of treatment 
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or 
moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are 
worried about them. 
 
Skin problems caused by the patch 
• You may get redness and itching on the skin where the patch has been – these reactions are 

usually mild or moderate. 
• The reactions normally go away after a few hours – once you remove the patch. 
• Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. 

Also do this if it spreads outside the area of skin that was covered by the patch. 
• Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused 

by the patch.  
• To help avoid the skin reactions, you should put the patch on a different area of skin every day, 

and only use the same area again after 14 days. 
 
Loss of consciousness can occur 
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or 
when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 
 



168 

Changes in behaviour and abnormal thinking 
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. 
They will discuss ways of managing or reducing symptoms.  
 
You may find it helpful to also tell a member of your family or carer that you are using this medicine 
and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if 
they are worried about any changes in your behaviour. Leganto can cause unusual urges or cravings 
which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself 
or others.  
 
These may include: 
• strong impulse to gamble too much – even if this seriously affects you or your family 
• altered or increased sexual interest and behaviour which causes significant concern to you or 

others – for example, an increased sex drive 
• uncontrolled shopping or spending too much 
• binge eating (eating large amounts of food in a short period of time) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger). 
 
Leganto may cause other behaviours and abnormal thinking. These may include: 
• abnormal thoughts about reality 
• delusions and hallucinations (seeing or hearing things that are not real) 
• confusion 
• disorientation 
• aggressive behaviour 
• agitation 
• delirium.  
 
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. 
They will discuss ways of managing or reducing symptoms.  
 
Allergic reactions 
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, 
tongue or lips. 
 
Side effects when using Leganto for Parkinson’s disease 
Tell your doctor, pharmacist or nurse if you get any of the following side effects: 
 
Very common: may affect more than 1 in 10 people  
• headache 
• feeling sleepy or dizzy 
• feeling sick (nausea), vomiting 
• skin reactions under the patch such as redness and itching 
 
Common: may affect up to 1 in 10 people  
• falling 
• hiccups  
• weight loss 
• swelling of legs and feet  
• feeling weak (fatigue), feeling tired  
• feeling of heartbeat (palpitation) 
• constipation, dry mouth, heartburn 
• redness, increased sweating, itching 
• vertigo (sensation of whirling motion) 
• seeing or hearing things that are not real (hallucinations) 
• low blood pressure when standing up, high blood pressure  



169 

• difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams  
• movements you cannot control related to Parkinson’s disease (dyskinesia) 
• fainting, feeling dizzy when standing up because of fall in blood pressure 
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, 

repetitive meaningless actions, uncontrolled shopping or spending too much 
• binge eating (eating large amount of food in a short period of time), compulsive eating (eating 

more food than normal and more than needed to satisfy hunger) 
 
Uncommon: may affect up to 1 in 100 people  
• blurred vision 
• weight increase 
• allergic reaction 
• low blood pressure 
• increased heart rate 
• increased sex drive 
• abnormal heart beat  
• stomach discomfort and pain 
• generalised itching, skin irritation 
• falling asleep suddenly without warning 
• unable to achieve or maintain an erection 
• feeling agitated, disorientated, confused or paranoid 
• increased or abnormal liver test results 
• sight problems such as seeing colours or lights 
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal 

muscles). 
 
Rare: may affect up to 1 in 1,000 people  
• delusion 
• delirium 
• feeling irritable 
• being aggressive  
• psychotic disorders  
• rash over larger parts of the body 
• involuntary muscle spasms (convulsion) 
 
Not known: it is not known how often these happen 
• craving large doses of medicines like Leganto – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto. 
• diarrhoea 
• dropped head syndrome 
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of 

the muscles and may lead to kidney problems) 
 
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Leganto 
 
Keep this medicine out of the sight and reach of children. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


170 

 
Do not use this medicine after the expiry date which is stated on the label and carton. 
 
Do not store above 30°C. 
 
What to do with the used and unused patches 
• Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. 

Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then 
throw it away safely, out of the reach of children. 

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Leganto contains 
The active substance is rotigotine. 
• 2 mg/24 h: 

Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm2 contains 4.5 mg of 
rotigotine. 
 

• 4 mg/24 h: 
Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 20 cm2 contains 9.0 mg of 
rotigotine. 
 

• 6 mg/24 h: 
Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30 cm2 contains 13.5 mg of 
rotigotine. 
 

• 8 mg/24 h: 
Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 cm2 contains 18.0 mg of 
rotigotine. 

 
The other ingredients are:  
• Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium 

metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307). 
 

• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium 
dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, 
pigment yellow 95, pigment black 7). 
 

• Release liner: Transparent fluoropolymer coated polyester film. 
 
What Leganto looks like and contents of the pack 
Leganto is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges. 
The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 
8 mg/24 h. 
 
Leganto is available in the following pack-sizes: 
One treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 
4 mg, 6 mg, and 8 mg each, which are individually sealed in sachets. 
 
Marketing Authorisation Holder  
 
UCB Pharma S.A. 
Allée de la Recherche 60 



171 

B-1070 Bruxelles 
Belgium 
 
Manufacturer 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l’Alleud 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: +359-(0)2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: +32-(0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: +420-221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: +36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: +356-21 37 64 36 
 

Deutschland 
Bayer Vital GmbH 
Tel: +49-(0)214-30 513 48 
 

Nederland 
UCB Pharma B.V. 
Tel.: +31-(0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: +45-32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: +30-2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: +43-(0)1 291 80 00 

España 
UCB Pharma S.A. 
Tel: +34-91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel.: +48-22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: +33-(0)1 47 29 44 35 

Portugal 
BIAL-Portela & Cª, S.A. 
Tel: +351-22 986 61 00 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385-(0)1 230 34 46 
 

România 
UCB Pharma România S.R.L. 
Tel: +40-21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: +353-(0)1 46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: +386-1 589 69 00 
 



172 

Ísland 
Vistor hf. 
Sími: +354-535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: +421-(0)2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: +39-02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: +358-92 514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: +357-22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: +46-(0)40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: +358-92 514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel : +44-(0)1753 534 655 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/