Neupro

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



2 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 1 mg/24 h transdermal patch 

Neupro 3 mg/24 h transdermal patch 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Neupro 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.  

 

Neupro 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.  

 

Neupro 1 mg/24 h transdermal patch 

The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 1 mg/24 h’. 

 

Neupro 3 mg/24 h transdermal patch 

The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 3 mg/24 h’. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Neupro 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.  

 

Neupro 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. 

 



3 

Treatment discontinuation 

 

Neupro 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 Neupro (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 

 

Neupro 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. Neupro 

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 

4.4 Special warnings and precautions for use 

 

Magnetic resonance imaging and cardioversion 

 

The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro 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. 



5 

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 Neupro is observed, Neupro 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 

 

Neupro 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 Neupro, 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. 



6 

 

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. 

 

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 Neupro- 

and 214 placebo-treated patients, 65.5% of the patients on Neupro 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. 

 



7 

Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro 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 Neupro, 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 Neupro 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 



8 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare Not known 

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 

General 

disorders and 

administration 

site conditions 

Application and 

instillation site 

reactionsa (incl. 

erythema, 

pruritus, 

Irritability, 

oedema 

peripheral 

   



9 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare Not known 

irritation, rash, 

dermatitis, 

vesicles, pain, 

eczema, 

inflammation, 

swelling, 

discolouration, 

papules, 

exfoliation, 

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). 

 



10 

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.  

 

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


11 

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 

 

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. 



12 

 

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 Neupro 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. Neupro 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 



13 

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. 

 

6.3 Shelf life 

 

30 months. 

 

6.4 Special precautions for storage 

 

Do not store above 30°C. 

 



14 

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, 14, 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) 

 

Neupro 1 mg/24 h transdermal patch 

EU/1/05/331/038 

EU/1/05/331/040 

EU/1/05/331/041 

EU/1/05/331/044  

EU/1/05/331/056 

 

Neupro 3 mg/24 h transdermal patch 

EU/1/05/331/047 

EU/1/05/331/049 

EU/1/05/331/050 

EU/1/05/331/053  

EU/1/05/331/058 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 15 February 2006 

Date of latest renewal: 22 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 

 

Neupro 2 mg/24 h transdermal patch 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 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 ‘Neupro 2 mg/24 h’. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Restless Legs Syndrome 

 

Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs 

Syndrome (RLS) in adults. 

 

Parkinson’s disease 

 

Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s 

disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course 

of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent 

and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations). 

 

4.2 Posology and method of administration 

 

Posology 

 

The dose recommendations made are in nominal dose. 

 

Restless Legs Syndrome 

 

A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the 

dose may be increased in weekly increments of 1 mg/24 h to a maximum dose of 3 mg/24 h. The need 

for treatment continuation should be reconsidered every 6 months.  

 

Parkinson’s disease 

 

Dosing in patients with early-stage Parkinson’s disease: 

A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 

2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h. 

4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached 

within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively. 

The maximum dose is 8 mg/24 h. 



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.  

 

Neupro 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 

 

Neupro 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 Neupro (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 

 

Neupro 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 Neupro (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 Neupro in the paediatric population in Parkinson’s disease. 

 



17 

Method of administration 

 

Neupro 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. Neupro 

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 Neupro contains aluminium. To avoid skin burns, Neupro 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 



18 

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. 

 

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. 



19 

If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or 

pruritus) associated with the use of Neupro is observed, Neupro 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. Peripheral oedema has also been 

observed in clinical trials conducted in patients with RLS. 

 

Sulphite sensitivity 

 

Neupro 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 Neupro, 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. 

 

Neupro 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).  



20 

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 

 

Restless Legs Syndrome 

 

Summary of the safety profile 

 

Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- 

and 214 placebo-treated patients, 65.5% of the patients on Neupro 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 Neupro 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 Neupro, 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 Neupro in 7.2% of subjects. 

 



21 

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 



22 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare Not known 

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 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare Not known 

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 Neupro- 

and 607 placebo-treated patients, 72.5% of the patients on Neupro 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. 



24 

 

Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro 

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 Neupro 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 Neupro in only 4.3% of all 

subjects receiving Neupro. 

 

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 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare 

 

Not known 

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 

  



26 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare 

 

Not known 

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 
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). 

 



27 

 
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.  

 

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


28 

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-

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) 



29 

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-

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 



30 

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. 

>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%. 

 



31 

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 Neupro 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. Neupro 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. 



32 

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. 

 

6.3 Shelf life 

 

30 months. 

 



33 

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, 14, 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) 

 

EU/1/05/331/001 

EU/1/05/331/002 

EU/1/05/331/015 

EU/1/05/331/018  

EU/1/05/331/057 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 15 February 2006 

Date of latest renewal: 22 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 

 

Neupro 4 mg/24 h transdermal patch 

Neupro 6 mg/24 h transdermal patch 

Neupro 8 mg/24 h transdermal patch 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Neupro 4 mg/24 h transdermal patch 

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

rotigotine. 

 

Neupro 6 mg/24 h transdermal patch 

Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 30 cm2 contains 13.5 mg of 

rotigotine. 

 

Neupro 8 mg/24 h transdermal patch 

Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 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.  

 

Neupro 4 mg/24 h transdermal patch 

The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h’. 

 

Neupro 6 mg/24 h transdermal patch 

The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h’. 

 

Neupro 8 mg/24 h transdermal patch 

The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h’. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s 

disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course 

of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent 

and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations). 

 

4.2 Posology and method of administration 

 

Posology 

 

The dose recommendations made are in nominal dose. 

 



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.  

 

Neupro 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 

 

Neupro 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 Neupro (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 Neupro in the paediatric population in Parkinson’s disease. 

 

Method of administration 

 

Neupro 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. Neupro 

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 Neupro contains aluminium. To avoid skin burns, Neupro 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. 

 



37 

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 Neupro is observed, Neupro 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. 

 



38 

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. 

 

Sulphite sensitivity 

 

Neupro 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 Neupro, 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. 

 

Neupro 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. 

 



39 

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 1,307 Neupro- 

and 607 placebo-treated patients, 72.5% of the patients on Neupro 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 Neupro 

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 Neupro 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 Neupro in only 4.3% of all 

subjects receiving Neupro. 

 

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 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare 

 

Not known 

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   



41 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare 

 

Not known 

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 

 

 

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 

 



42 

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 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. 

 

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


43 

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, 

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 



44 

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-

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 



45 

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. 

>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. 



46 

 

Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is 

expected. 

 

Special patient groups 

 

Because therapy with Neupro 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. Neupro 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. 

 

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,  



47 

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, 14, 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 

 

 



48 

8. MARKETING AUTHORISATION NUMBER(S) 

 

Neupro 4 mg/24 h transdermal patch 

EU/1/05/331/004 

EU/1/05/331/005 

EU/1/05/331/021 

EU/1/05/331/024  

EU/1/05/331/059 

 

Neupro 6 mg/24 h transdermal patch 

EU/1/05/331/007 

EU/1/05/331/008 

EU/1/05/331/027 

EU/1/05/331/030  

EU/1/05/331/060 

 

Neupro 8 mg/24 h transdermal patch 

EU/1/05/331/010 

EU/1/05/331/011 

EU/1/05/331/033 

EU/1/05/331/036  

EU/1/05/331/061 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 15 February 2006 

Date of latest renewal: 22 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 

 

Neupro 

2 mg/24 h  

4 mg/24 h  

6 mg/24 h  

8 mg/24 h  

Transdermal patch 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Neupro 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.  

 

Neupro 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. 

 

Neupro 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.  

 

Neupro 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 ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 

8 mg/24 h’. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s 

disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course 

of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent 

and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations). 

 

4.2 Posology and method of administration 

 

Posology 

 

The dose recommendations made are in nominal dose. 

 



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. 

 

Neupro 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 Neupro 2 mg/24 h. During the second week, the 

patient takes Neupro 4 mg/24 h. During the third week, he or she takes Neupro 6 mg/24 h and during 

the fourth week Neupro 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”. 

 

Neupro 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 

 

Neupro 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 Neupro (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 Neupro in the paediatric population in Parkinson’s disease. 

 

Method of administration 

 

Neupro 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. Neupro 

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 Neupro contains aluminium. To avoid skin burns, Neupro 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.  

 



52 

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. 

 

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 Neupro is observed, Neupro should be discontinued. 

 



53 

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. 

 

Sulphite sensitivity 

 

Neupro 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 Neupro, 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. 

 

Neupro 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.  

 



54 

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 1,307 Neupro- 

and 607 placebo-treated patients, 72.5% of the patients on Neupro 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 Neupro 

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 Neupro 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 Neupro in only 4.3% of all 

subjects receiving Neupro. 

 

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. 

 



55 

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 

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    



56 

System/organ 

classes acc. to 

MedDRA 

Very common 

 

Common 

 

Uncommon 

 

Rare 

 

Not known 

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 

 

 

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 



57 

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). 

 
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.  

 

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


58 

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, 

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 



59 

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-

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.  



60 

 

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. 

>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. 

 



61 

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 Neupro 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. Neupro 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. 

 

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. 

 

 



62 

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 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 



63 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/05/331/013 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 15 February 2006 

Date of latest renewal: 22 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/


64 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 



65 

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 

 



66 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



67 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



68 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 

 

 



69 

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/1/05/331/038 [7 transdermal patches] 

EU/1/05/331/040 [28 transdermal patches] 

EU/1/05/331/041 [30 transdermal patches]  

EU/1/05/331/056 [14 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 

 

neupro 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: 



70 

 

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 

 

Neupro 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:  

 

 



71 

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/1/05/331/044 [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 

 

neupro 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: 



72 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



73 

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/1/05/331/044 [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 

 

neupro 1 mg/24 h 

 



74 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



75 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 

 



76 

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/1/05/331/001 [7 transdermal patches] 

EU/1/05/331/002 [28 transdermal patches] 

EU/1/05/331/015 [30 transdermal patches]  

EU/1/05/331/057 [14 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 

 

neupro 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: 



77 

 

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 

 

Neupro 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:  

 

 



78 

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/1/05/331/018 [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 

 

neupro 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: 



79 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



80 

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/1/05/331/018 [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 

 

neupro 2 mg/24 h 

 



81 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



82 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 



83 

 

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/1/05/331/047 [7 transdermal patches] 

EU/1/05/331/049 [28 transdermal patches] 

EU/1/05/331/050 [30 transdermal patches]  

EU/1/05/331/058 [14 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 

 

neupro 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: 



84 

 

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 

 

Neupro 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:  

 

 



85 

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/1/05/331/053 [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 

 

neupro 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: 



86 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



87 

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/1/05/331/053 [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 

 

neupro 3 mg/24 h 

 



88 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 



89 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 



90 

 

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/1/05/331/004 [7 transdermal patches] 

EU/1/05/331/005 [28 transdermal patches] 

EU/1/05/331/021 [30 transdermal patches]  

EU/1/05/331/059 [14 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 

 

neupro 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: 



91 

 

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 

 

Neupro 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:  

 

 



92 

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/1/05/331/024 [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 

 

neupro 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:



93 

  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



94 

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/1/05/331/024 [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 

 

neupro 4 mg/24 h 

 



95 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



96 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 

 



97 

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/1/05/331/007 [7 transdermal patches] 

EU/1/05/331/008 [28 transdermal patches] 

EU/1/05/331/027 [30 transdermal patches]  

EU/1/05/331/060 [14 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 

 

neupro 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: 



98 

 

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 

 

Neupro 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:  

 

 



99 

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/1/05/331/030 [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 

 

neupro 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: 



100 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



101 

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/1/05/331/030 [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 

 

neupro 6 mg/24 h 



102 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



103 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOX OF 7 [14] [28] [30] PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

14 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:  

 

 



104 

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/1/05/331/010 [7 transdermal patches] 

EU/1/05/331/011 [28 transdermal patches] 

EU/1/05/331/033 [30 transdermal patches]  

EU/1/05/331/061 [14 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 

 

neupro 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: 



105 

 

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 

 

Neupro 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:  

 

 



106 

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/1/05/331/036 [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 

 

neupro 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: 



107 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

MULTIPACKS ONLY 

INTERMEDIATE BOX (WITHOUT BLUE BOX)  

BOX OF 28 PATCHES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



108 

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/1/05/331/036 [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 

 

neupro 8 mg/24 h  

 



109 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 



110 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT 

SCHEDULE 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 

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) 

 

Neupro 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. 

 

Neupro 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. 

 

Neupro 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. 

 

Neupro 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 Neupro 2 mg/24 h 

7 transdermal patches of Neupro 4 mg/24 h 

7 transdermal patches of Neupro 6 mg/24 h 

7 transdermal patches of Neupro 8 mg/24 h 

 

 



111 

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. 

 

 

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/1/05/331/013 

 

 

13. BATCH NUMBER 

 

Lot:  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

 



112 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

neupro 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: 

 



113 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

BOX OF 7 PATCHES – WEEK 1 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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 

 

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:  

 

 



114 

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/1/05/331/013 

 

 

13. BATCH NUMBER 

 

Lot:  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

neupro 2 mg/24 h 



115 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL – WEEK 1 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



116 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

BOX OF 7 PATCHES – WEEK 2 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 



117 

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/1/05/331/013 

 

 

13. BATCH NUMBER 

 

Lot:  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

neupro 4 mg/24 h 



118 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL – WEEK 2 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



119 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

BOX OF 7 PATCHES – WEEK 3 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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:  

 

 

 



120 

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/1/05/331/013 

 

 

13. BATCH NUMBER 

 

Lot:  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

neupro 6 mg/24 h 



121 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL - WEEK 3 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



122 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

BOX OF 7 PATCHES – WEEK 4 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Neupro 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: 

 

 



123 

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/1/05/331/013 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

neupro 8 mg/24 h 



124 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHET LABEL – WEEK 4 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Neupro 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 

 



125 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



126 

Package leaflet: Information for the user 

 

Neupro 1 mg/24 h transdermal patch 

Neupro 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 Neupro is and what it is used for 

2. What you need to know before you use Neupro 

3. How to use Neupro 

4. Possible side effects 

5. How to store Neupro 

6. Contents of the pack and other information 

 

 

1. What Neupro is and what it is used for 

 

What Neupro is 

Neupro contains the active substance rotigotine.  

 

It belongs to a group of medicines called ‘dopamine agonists’. Dopamine is a messenger in the brain 

which is important for movement. 

 

What Neupro is used for  

Neupro is used in adults to treat the signs and symptoms of: 

 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 Neupro treatment. 

 

 

2. What you need to know before you use Neupro 

 

Do not use Neupro if: 

 you are allergic to rotigotine or any of the other ingredients of this medicine (listed in 

section 6) 

 you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside 

of the body, created using magnetic rather than x-ray energy) 

 you need ‘cardioversion’ (specific treatment for abnormal heart beat). 

 

You must take your Neupro patch off just before 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 Neupro. If you are not sure about this, talk to your doctor 

or pharmacist first. 



127 

Warnings and precautions 

Talk to your doctor or pharmacist before using Neupro. This is because: 

 your blood pressure needs checking regularly while using Neupro, especially at the start of the 

treatment. Neupro may affect your blood pressure. 

 your eyes need checking regularly while using Neupro. 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 Neupro, contact your doctor as your treatment may need to be adjusted. 

 

Loss of consciousness can occur 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or 

when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 

 

Changes in behaviour and abnormal thinking 

Neupro 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 Neupro 

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 Neupro – 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 Neupro if you are taking: 

 sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 

 medicines that lower blood pressure. Neupro 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 Neupro. 

 

Neupro 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 Neupro. 

 



128 

Pregnancy and breast-feeding 

Do not use Neupro 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 Neupro. 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 

Neupro 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. 

 

Neupro 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 Neupro 

 

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 

Neupro 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 Neupro’ in section 3. 

 

How to use the Neupro patches 

Neupro 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 Neupro patches into pieces. 
 



129 

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 Neupro 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 Neupro patch onto your skin as soon as you have opened the sachet and removed the 

release liner. 

 



130 

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. 

 



131 

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 Neupro than you should 

Using higher doses of Neupro 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 Neupro 

Do not stop using Neupro 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: 



132 

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 Neupro, 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 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro 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. Neupro 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). 

 

Neupro 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) 



133 

 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 Neupro for Restless Legs Syndrome 

Tell your doctor or pharmacist if you get 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 Neupro – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro 

 seeing or hearing things that are not real (hallucinations) 

 nightmares 

 paranoia 

 confusion 

 psychotic disorders 

 delusion 



134 

 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 

 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 Neupro 

 

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


135 

6. Contents of the pack and other information 

 

What Neupro contains 

The active substance is rotigotine. 

 1 mg/24 h: 

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 Neupro looks like and contents of the pack 

Neupro 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 Neupro 1 mg/24 h or 3 mg/24 h. 

 

Neupro is available in the following pack-sizes: 

Boxes containing 7, 14, 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 

 



136 

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 

UCB Pharma GmbH 

Tel: +49-(0) 2173 48 48 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} 

 



137 

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/


138 

Package leaflet: Information for the user 

 

Neupro 2 mg/24 h transdermal patch 

Rotigotine 

 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

 Keep this leaflet. You may need to read it again. 

 If you have any further questions, ask your doctor, pharmacist or nurse. 

 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

1. What Neupro is and what it is used for 

2. What you need to know before you use Neupro 

3. How to use Neupro 

4. Possible side effects 

5. How to store Neupro 

6. Contents of the pack and other information 

 

 

1. What Neupro is and what it is used for 

 

What Neupro is 

Neupro contains the active substance rotigotine.  

 

It belongs to a group of medicines called ‘dopamine agonists’. Dopamine is a messenger in the brain 

which is important for movement. 

 

What Neupro is used for  

Neupro is used in adults to treat the signs and symptoms of:  

 Parkinson’s disease – Neupro can be used on its own or with another medicine called 

levodopa. 

 Restless Legs Syndrome (RLS) – this can be associated with discomfort in your legs or arms, 

urge to move around, sleep disturbance and feeling tired or sleepy during the day. These 

symptoms are either reduced or their duration is shortened with Neupro treatment.  

 

 

2. What you need to know before you use Neupro 

 

Do not use Neupro if: 

 you are allergic to rotigotine or any of the other ingredients of this medicine (listed in 

section 6) 

 you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside 

of the body, created using magnetic rather than x-ray energy)  

 you need ‘cardioversion’ (specific treatment for abnormal heart beat). 

 

You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or 

cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on 

afterwards. 

 



139 

If any of the above apply to you, do not use Neupro. 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 Neupro. This is because: 

 your blood pressure needs checking regularly while using Neupro, especially at the start of the 

treatment. Neupro may affect your blood pressure. 

 your eyes need checking regularly while using Neupro. 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 Neupro, contact your doctor as your treatment may need to be adjusted.  

 

Loss of consciousness can occur 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or 

when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 

 

Changes in behaviour and abnormal thinking 

Neupro 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 Neupro 

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 Neupro 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 Neupro – because they may decrease its effect: 

 ‘anti-psychotic’ medicines – used to treat certain mental illnesses 

 metoclopramide – used to treat nausea (feeling sick) and vomiting.  

 



140 

Talk to your doctor before using Neupro if you are taking: 

 sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 

 medicines that lower blood pressure. Neupro 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 Neupro. 

 

Neupro 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 Neupro. 

 

Pregnancy and breast-feeding 

Do not use Neupro 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 Neupro. 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 

Neupro 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. 

 

Neupro 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 Neupro 

 

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 Neupro will depend on your illness – see below. 

 

Neupro 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.  

 



141 

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.  

 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 Neupro’ in section 3. 

 

How to use the Neupro patches: 

Neupro 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 Neupro 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. 

  
 



142 

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 Neupro 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 Neupro 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. 

 



143 

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. 

 
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. 

 



144 

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 Neupro than you should 

Using higher doses of Neupro 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 Neupro 

Do not stop using Neupro 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 Neupro, 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. 

 



145 

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 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro 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. Neupro 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). 

 

Neupro 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. 

 



146 

Side effects when using Neupro 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 

 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  



147 

 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 Neupro – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro. 

 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 Neupro 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 Neupro – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro 

 seeing or hearing things that are not real (hallucinations) 

 nightmares 

 paranoia 

 confusion 

 psychotic disorders 

 delusion 



148 

 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 

 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 Neupro 

 

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


149 

6. Contents of the pack and other information 

 

What Neupro 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 Neupro looks like and contents of the pack 

Neupro 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 Neupro 2 mg/24 h. 

 

Neupro is available in the following pack-sizes: 

Boxes containing 7, 14, 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 

 



150 

Danmark 

UCB Nordic A/S 

Tlf: +45-32 46 24 00 

 

Malta 

Pharmasud Ltd. 

Tel: +356-21 37 64 36 

 

Deutschland 

UCB Pharma GmbH 

Tel: +49-(0) 2173 48 48 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/


151 

Package leaflet: Information for the user 

 

Neupro 4 mg/24 h transdermal patch 

Neupro 6 mg/24 h transdermal patch 

Neupro 8 mg/24 h transdermal patch 

Rotigotine 

 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

 Keep this leaflet. You may need to read it again. 

 If you have any further questions, ask your doctor, pharmacist or nurse. 

 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

1. What Neupro is and what it is used for 

2. What you need to know before you use Neupro 

3. How to use Neupro 

4. Possible side effects 

5. How to store Neupro 

6. Contents of the pack and other information 

 

 

1. What Neupro is and what it is used for 

 

What Neupro is 

Neupro contains the active substance rotigotine.  

 

It belongs to a group of medicines called ‘dopamine agonists’. Dopamine is a messenger in the brain 

which is important for movement 

 

What Neupro is used for 

Neupro is used in adults to treat the signs and symptoms of:  

 Parkinson’s disease – Neupro can be used on its own or with another medicine called 

levodopa. 

 

 

2. What you need to know before you use Neupro 

 

Do not use Neupro if: 

 you are allergic to rotigotine or any of the other ingredients of this medicine (listed in 

section 6) 

 you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside 

of the body, created using magnetic rather than x-ray energy)  

 you need ‘cardioversion’ (specific treatment for abnormal heart beat). 

 

You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or 

cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on 

afterwards. 

 



152 

If any of the above apply to you, do not use Neupro. 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 Neupro. This is because: 

 your blood pressure needs checking regularly while using Neupro, especially at the start of the 

treatment. Neupro may affect your blood pressure. 

 your eyes need checking regularly while using Neupro. 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 Neupro, contact your doctor. 

 

Loss of consciousness can occur 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or 

when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 

 

Changes in behaviour and abnormal thinking 

 

Neupro 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 Neupro 

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 Neupro 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 Neupro – 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 Neupro if you are taking: 

 sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 



153 

 medicines that lower blood pressure. Neupro 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 Neupro. 

 

Neupro 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 Neupro. 

 

Pregnancy and breast-feeding 

Do not use Neupro 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 Neupro. 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 

Neupro 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. 

 

Neupro 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 Neupro 

 

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 Neupro will depend on your illness – see below. 

 

Neupro 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.  



154 

 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. 

 

If you have to stop taking this medicine, see ‘If you stop using Neupro’ in section 3. 

 

How to use the Neupro patches 

Neupro 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 Neupro 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 Neupro 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. 

  



155 

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 Neupro 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. 
 



156 

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. 

 



157 

If you use more Neupro than you should 

Using higher doses of Neupro 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 Neupro 

Do not stop using Neupro 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 Neupro, 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 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro 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.  



158 

 

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. Neupro 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). 

 

Neupro 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 Neupro 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) 



159 

 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 Neupro – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro. 

 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 Neupro 

 

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


160 

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 Neupro 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 Neupro looks like and contents of the pack 

Neupro 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 Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 

8 mg/ 24 h. 

 

Neupro is available in the following pack-sizes: 

Boxes containing 7, 14, 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 

 



161 

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 

UCB Pharma GmbH 

Tel: +49-(0) 2173 48 48 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 

 



162 

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/


163 

Package leaflet: Information for the user 

 

Neupro 2 mg/24 h 

Neupro 4 mg/24 h 

Neupro 6 mg/24 h 

Neupro 8 mg/24 h 

Transdermal patch 

Rotigotine 

 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

 Keep this leaflet. You may need to read it again. 

 If you have any further questions, ask your doctor, pharmacist or nurse. 

 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

1. What Neupro is and what it is used for 

2. What you need to know before you use Neupro 

3. How to use Neupro 

4. Possible side effects 

5. How to store Neupro 

6. Contents of the pack and other information 

 

 

1. What Neupro is and what it is used for 

 

What Neupro is 

Neupro contains the active substance rotigotine.  

 

It belongs to a group of medicines called ‘dopamine agonists’. Dopamine is a messenger in the brain 

which is important for movement. 

 

What Neupro is used for 

Neupro is used in adults to treat the signs and symptoms of:  

 Parkinson’s disease – Neupro can be used on its own or with another medicine called 

levodopa. 

 

 

2. What you need to know before you use Neupro 

 

Do not use Neupro if: 

 you are allergic to rotigotine or any of the other ingredients of this medicine (listed in 

section 6) 

 you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside 

of the body, created using magnetic rather than x-ray energy)  

 you need ‘cardioversion’ (specific treatment for abnormal heart beat). 

 

You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or 

cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on 

afterwards. 



164 

 

If any of the above apply to you, do not use Neupro. 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 Neupro. This is because 

 your blood pressure needs checking regularly while using Neupro, especially at the start of the 

treatment. Neupro may affect your blood pressure. 

 your eyes need checking regularly while using Neupro. 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 Neupro, contact your doctor. 

 

Loss of consciousness can occur 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or 

when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 

 

Changes in behaviour and abnormal thinking 

Neupro 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 Neupro 

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 Neupro 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 Neupro – 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 Neupro if you are taking: 

 sedating medicines such as benzodiazepines or medicines used to treat mental illness or 

depression. 



165 

 medicines that lower blood pressure. Neupro 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 Neupro. 

 

Neupro 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 Neupro. 

 

Pregnancy and breast-feeding 

Do not use Neupro 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 Neupro. 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 

Neupro 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. 

 

Neupro 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 Neupro 

 

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 Neupro will depend on your illness – see below. 

  

Neupro 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 Neupro 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 Neupro, 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 Neupro 2 mg (package marked “Week 1”), and use one 

Neupro 2 mg transdermal patch daily. You should take Neupro 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 Neupro 4 mg (package marked with “Week 2”). 

At the beginning of the third week, you should take Neupro 6 mg (package marked with “Week 3”). 

At the beginning of the fourth week, you should take Neupro 8 mg (package marked with “Week 4”). 

 



166 

The right dose for you will depend on your needs. 

4 mg of Neupro 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 can 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 Neupro’ in section 3. 

 

How to use the Neupro patches  

Neupro 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 Neupro 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 Neupro 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. 

 



167 

 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 Neupro 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. 
 



168 

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. 

 

If you use more Neupro than you should 

Using higher doses of Neupro 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 



169 

(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. Neupro 4 mg/24 h instead of Neupro 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 Neupro 

Do not stop using Neupro 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 Neupro, the daily dose of Neupro 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 

Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or 

when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. 

 



170 

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. Neupro 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). 

 

Neupro 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 Neupro 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) 



171 

 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 

 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 Neupro – more than needed for the illness. This is known 

as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro. 

 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. 

 

 

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


172 

5. How to store Neupro 

 

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 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 Neupro 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 Neupro looks like and contents of the pack 

Neupro 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 Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 

8 mg/24 h. 

 

Neupro 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. 

 



173 

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 

UCB Pharma GmbH 

Tel: +49-(0) 2173 48 48 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 

 



174 

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/

	SUMMARY OF PRODUCT CHARACTERISTICS
	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
	A. LABELLING
	B. PACKAGE LEAFLET