Neupro: detailed information

Patient Information Leaflet: Information for the User

Neupro 1 mg/24 h transdermal patch, 3 mg/24 h transdermal patch

Rotigotine
Please read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Neupro is and what it is used for
What you need to know before using Neupro
How to use Neupro
Possible side effects
How to store Neupro
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 class of medicines called "dopamine agonists". Dopamine is a substance present in the brain responsible for transmitting signals, and its function is important for movement.
What Neupro is used for
Neupro is indicated in adults for the treatment of signs and symptoms of:

Restless legs syndrome – this may be associated with discomfort in the legs and arms, an irresistible urge to move the legs, sleep disturbances, and feelings of fatigue or daytime sleepiness. Treatment with Neupro reduces these symptoms and decreases their duration.

2. What you need to know before using Neupro

Do not take Neupro if:

you are allergic to rotigotine or to any of the other ingredients of this medicine (listed in section 6)
you are due to have a magnetic resonance imaging (MRI) scan (diagnostic images of the inside of the body obtained using magnetic fields instead of X-rays)
you are due to have cardioversion (a specific treatment for an abnormal heart rhythm). Immediately before undergoing MRI or cardioversion, you must remove the Neupro patch to avoid skin burns, as the patch contains aluminium. You may then apply a new patch. If any of the above conditions apply to you, do not use Neupro. If you are unsure, speak 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 should be monitored regularly while you are using Neupro, especially at the beginning of treatment. Neupro can affect blood pressure.
your eyes should be checked regularly while you are using Neupro. If you notice any vision problems between check-ups, contact your doctor immediately.
if you have severe liver problems, your doctor may consider adjusting your dose. If your liver problems worsen during treatment, contact your doctor immediately.
skin reactions caused by the patch may occur – see “Skin reactions caused by the patch” in section 4.
you may feel very sleepy or fall asleep suddenly – see “Driving and use of machines” in section 2.
symptoms of Restless Legs Syndrome may start earlier than usual, become more intense, or affect other limbs. If you experience such symptoms before or after starting Neupro treatment, contact your doctor, as your treatment may need to be adjusted. Medicines used to treat Restless Legs Syndrome should be reduced or stopped gradually. Inform your doctor if, after stopping or reducing Neupro treatment, you experience symptoms such as depression, anxiety, fatigue, sweating, or pain.
Loss of consciousness may occur
Neupro may cause loss of consciousness. This is particularly likely when you first start using Neupro or when your dose is increased. Inform your doctor if you lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking
Neupro may cause side effects that affect your behaviour (the way you act). It may be helpful to inform a family member or caregiver that you are using this medicine and ask them to read this leaflet. This way, a family member or caregiver can inform you or your doctor if they are concerned about any changes in your behaviour. Inform your doctor if you or a family member/caregiver notice that you are using the medicine excessively or developing a strong desire for high doses of Neupro or other medicines used to treat Restless Legs Syndrome. See “Changes in behaviour and abnormal thinking” in section 4 for more information.

Children and adolescents
Do not give this medicine to children under 18 years of age, as the safety and efficacy of the medicine in this age group have not been established.

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 without a prescription and herbal medicines. While using Neupro, do not take the following medicines – as they may reduce its effect:

“antipsychotic” medicines – used to treat certain mental disorders
metoclopramide – used for nausea (feeling unwell) and vomiting.

Inform your doctor before using Neupro if you are taking:

sedative medicines such as benzodiazepines or medicines used to treat mental disorders or depression.
medicines that lower blood pressure. Neupro can lower blood pressure when you stand up – this effect may be worsened by medicines used to lower blood pressure. Your doctor will advise whether it is safe for you to continue taking these medicines while using Neupro.

Neupro with food, drinks and alcohol
Since rotigotine passes into the blood through the skin, food and drinks do not affect how the medicine is absorbed by the body. Consult your doctor about whether you can drink alcohol while using Neupro.

Pregnancy and breastfeeding
Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn child are unknown. Do not breastfeed during treatment with Neupro. This is because rotigotine may pass into breast milk and affect the baby. In addition, a reduction in the amount of milk produced is likely. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and use of machines
Neupro may cause severe drowsiness and may cause you to fall asleep suddenly. If this happens, do not drive. In isolated cases, patients have fallen asleep while driving vehicles, resulting in accidents. Also, if you feel very sleepy, do not use tools or machinery – or engage in any other activity that could put you or others at risk of serious accidents.

Neupro contains sodium metabisulfite (E223)
Sodium metabisulfite (E223) may, rarely, cause severe hypersensitivity reactions (allergic reactions) and bronchospasm (breathing problems caused by narrowing of the airways).

3. How to take Neupro

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
What dose to use
Neupro is available in patches with different strengths that 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 Legs Syndrome.

The starting dose is one 1 mg/24 h patch per day.
From the second week onwards, the daily dose may be increased by 1 mg per week, until the appropriate maintenance dose for you is reached. This occurs when you and your doctor determine that your symptoms are adequately controlled and any side effects caused by the medicine are acceptable.
Always follow your doctor’s instructions exactly.
The maximum dose is 3 mg per day.

If you need to stop treatment, see “If you stop using Neupro” in section 3.
How to use Neupro patches
Neupro is a patch applied to the skin.

Make sure you have removed the old patch before applying a new one.
Apply the new patch to a different area of skin each day.
Leave the patch on the skin for 24 hours, then remove it and apply a new one.
Change patches every day at approximately the same time.
Do not cut Neupro patches into pieces. Where to apply the patch Apply the adhesive side of the patch to clean,

Three male human figures show drug application sites on abdomen, thighs, and arms in frontal, lateral, and posterior views

dry, and healthy skin, in the following areas, as shown
in grey in the figures on the side:

Shoulder or upper arm.
Abdomen.
Flank (between the ribs and hips).
Thigh or hip.

To avoid skin irritation

Apply the patch to a different area of skin each day. For example, apply it on the right side of the body one day, then on the left side the next day. One day on the upper part of the body, then the next day on the lower part.
Do not reapply Neupro to the same area of skin within 14 days.
Do not apply the patch to wounded or damaged skin, or to reddened or irritated skin. If you experience skin problems due to the patch, see “Skin reactions caused by the patch” in section 4 for further information. To prevent loss or detachment of the patch
Do not apply the patch to an area that may be rubbed by tight clothing.
Do not use creams, oils, lotions, powders, or other skin products where you will apply the patch. Also do not apply them over or near another patch already in place.
If you need to apply the patch to a hairy area, you should shave the area at least three days before applying the patch.
If the edges of the patch lift, you may secure it further with medical adhesive tape. If the patch detaches completely, apply a new patch for the remainder of the day—then replace the patch at your usual time the next day.
Do not expose the patch area to heat—for example, excessive sunlight, sauna, very hot baths, heating pads, or hot water bottles. This is because the medicine may be released more quickly. Contact your doctor or pharmacist if you think you have been exposed to excessive heat.
Always check that the patch has not detached after activities such as bathing, showering, or physical exercise.
If the patch has caused skin irritation, do not expose the affected area to sunlight, as the skin may change color. How to use the patch
Each patch comes individually packaged in a sealed pouch.
Before opening the pouch, decide where you will apply the new patch and make sure you have removed the old patch.
Apply the Neupro patch to the skin immediately after opening the pouch and removing the protective film.

Two hands carefully hold and open a small rectangular package or leaflet against a white background

1.
To open the pouch, hold it
with both hands.

Two hands hold and open a small white rectangular container or package against a neutral background

2.
Separate the two layers of
the film.

Two hands hold and open a small white pouch to reveal a square adhesive patch inside

3.
Open the pouch.

Two hands hold and unfold a folded leaflet with a motion outward

4.
Remove the patch from
the pouch.

Two hands hold and manipulate a small white rectangular object against a light neutral background

5
The adhesive side of the patch
is covered by a transparent
protective layer.

Hold the patch with both hands, with the protective layer facing you.

Two hands hold and carefully open a small package or medicine vial in black and white

Fold the patch in half. This helps open the S-shaped tear line.

Two hands hold and break a white tablet into two equal parts against a neutral light background

Peel off one side of the protective liner.
Do not touch the adhesive side of the patch with your fingers.

A hand applies a patch or pad to the upper arm of a person bending forward

Hold the other side of the protective liner.
Then apply the adhesive half of the patch to the skin.
Press firmly on the adhesive part of the patch.

A hand gently presses with fingers on an area of the arm covered by a patch or dressing applied over the skin

9.
Fold back the other half of
the patch and peel off the
other side of the protective
layer.
10.

A bent arm with a hand pressing on the elbow next to a circular timer indicating thirty seconds

Press firmly over the patch with the palm of your hand.
Hold for 30 seconds. This ensures good contact with the skin and that the edges adhere properly.

11.
Wash your hands immediately
with water and soap after
handling the patch.
How to remove a used patch

Remove the used patch slowly and carefully.
Gently wash the area with lukewarm water and mild soap. This helps remove any adhesive residue left on the skin. For adhesive residue that does not come off with water, you may use a small amount of baby oil.
Do not use alcohol or other solvents—such as nail polish remover—as they may cause irritation.

If you use more Neupro than you should
Using higher doses of Neupro than prescribed by your doctor may cause side effects such as
feeling unwell (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), confusion, extreme drowsiness, involuntary movements, and seizures.
In such cases, contact your doctor or hospital immediately. They will give you instructions on what to do.
If you forget to replace the patch at the usual time

If you forgot to replace the patch at the usual time, apply a new one as soon as you remember. Remove the old patch and use a new one.
If you forgot to apply a new patch after removing the old one, apply a new patch as soon as you remember. In both cases, apply a new patch at the usual time the next day. Do not apply a double dose to make up for a missed dose. If you stop using Neupro Do not stop using Neupro without informing your doctor. Sudden discontinuation may cause you to develop a serious condition called “neuroleptic malignant syndrome,” which could be life-threatening. Signs include: loss of muscle movement (akinesia), muscle rigidity, fever, unstable blood pressure, rapid heartbeat (tachycardia), confusion, and reduced level of consciousness (e.g., coma). If your doctor has advised you to stop treatment with Neupro, the daily dose should be gradually reduced:
Restless Legs Syndrome—reduce by 1 mg every other day. If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any side effect, contact your doctor, pharmacist, or nurse.

More frequent side effects at the beginning of treatment
You may experience a feeling of discomfort (nausea) and vomiting at the beginning of treatment.
These effects are usually mild or moderate and last only a short time. Contact your doctor if they last a long time or concern you.

Skin problems caused by the patch

The patch may cause redness and itching at the site of application – these reactions are usually mild or moderate.
Reactions usually disappear within a few hours after removing the patch.
Inform your doctor if you have a skin reaction lasting more than a few days, if it is severe, or if it spreads beyond the area of skin covered by the patch.
Avoid exposing to sunlight or tanning lamps any skin areas showing a skin reaction caused by the patch.
To avoid skin reactions, apply the patch daily to a different skin area, and reuse the same area only after 14 days.

Loss of consciousness may occur
Neupro may cause loss of consciousness. This may occur particularly when you start using Neupro or when the dose is increased. Inform your doctor if you lose consciousness or experience dizziness.

Changes in behaviour and abnormal thinking
Inform your doctor if you notice any changes in behaviour, thinking, or both, listed below. Your doctor may decide on appropriate actions to manage or reduce the symptoms.
It may be helpful to inform a family member or caregiver that you are taking this medicine and ask them to read this leaflet. In this way, a family member or caregiver can inform you or your doctor if they are concerned about any changes in your behaviour.

Neupro may cause unusual urges or desires that make you unable to resist the impulse, drive, or temptation to carry out certain activities that could harm you or others.
These may include:

strong urge to gamble excessively – despite this having serious consequences for you or your family
altered or increased sexual interest and behaviour causing significant concern for you or others, for example increased sexual desire
uncontrolled buying or excessive spending
uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite).

Neupro may cause other abnormal thoughts and behaviours. These may include:

abnormal thoughts about reality
delirium, hallucinations (seeing or hearing things that are not real)
confusion
disorientation
aggressive behaviour
agitation
delirious speech.

Inform your doctor if you notice any changes in behaviour, thinking, or both, listed above.
Your doctor may decide on appropriate actions to manage or reduce the symptoms.

Allergic reactions
Contact your doctor if you notice signs of an allergic reaction – these may include swelling of the face, tongue and/or lips.

Side effects when using Neupro for restless legs syndrome
Inform 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 unwell (nausea)
feeling of weakness (fatigue)
skin irritation under the patch, such as redness and itching

Common: may affect up to 1 in 10 people

itching
feeling irritable
allergic reactions
increased sexual activity
high blood pressure
vomiting, heartburn
swelling of the legs and feet
drowsiness, sudden sleep without warning signs, difficulty sleeping, sleep disturbances, unusual dreams
inability to resist the impulse to perform an action that may cause harm, including excessive gambling, meaningless repetitive actions, uncontrolled buying or excessive spending
uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)

Uncommon: may affect up to 1 in 100 people

feeling of restlessness
dizziness when standing due to low blood pressure

Rare: may affect up to 1 in 1000 people

aggressive behaviour
disorientation

Not known: frequency cannot be estimated from the available data

strong desire for high doses of medicines such as Neupro – higher than needed to control the disease. This is also known as “dopamine dysregulation syndrome” and may lead to excessive use of Neupro
hearing or seeing things that are not real (hallucinations)
nightmares
paranoia
confusion
psychotic disorders
delirium
delirious speech
dizziness
loss of consciousness, involuntary movements (dyskinesia)
involuntary muscle spasms (convulsions)
blurred vision
visual disturbances such as seeing colours or lights
vertigo (sensation of spinning)
awareness of heartbeat (palpitations)
abnormal heart rhythm
low blood pressure
hiccups
constipation, dry mouth
stomach discomfort and pain
diarrhoea
redness, increased sweating
generalized itching, skin irritation
generalized skin rash
inability to achieve or maintain an erection
weight loss, weight gain
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)
falls
rhabdomyolysis (a rare, serious muscle disorder causing pain, tenderness, and muscle weakness, which could lead to kidney problems)

Inform your doctor or pharmacist if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the label and packaging.
Do not store above 30°C.
Disposal of used or unused patches

Used patches still contain the active substance “rotigotine”, which may be harmful to other people. Fold the used patch with the adhesive side inwards. Place the patch back into the original pouch and dispose of it safely, out of the reach of children.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Neupro contains
The active substance is rotigotine.

1 mg/24 h: Each patch releases 1 mg of rotigotine over 24 hours. Each 5 cm² patch contains 2.25 mg of rotigotine.
3 mg/24 h: Each patch releases 3 mg of rotigotine over 24 hours. Each 15 cm² patch contains 6.75 mg of rotigotine.

The other components are:

Poly(dimethylsiloxane, trimethylsilyl silicate) copolymer, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Backing layer: silicone- and aluminium-coated polyester film, coloured with a pigment layer (titanium dioxide (E171), pigment yellow 13, pigment red 166, pigment yellow 12) and printed with text (pigment red 146, pigment yellow 180, pigment black 7).
Protective layer: transparent fluoropolymer-coated polyester film.

Description of the appearance of Neupro and contents of the pack
Neupro is a transdermal patch. It is thin and composed of three layers. It is a square patch with rounded corners. The outer side of the backing layer is beige and bears the inscription 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 (multiple pack containing 3 packs of 28) individually sealed transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorization Holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels
Belgium

Manufacturer
UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine l’Alleud
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: +32-(0)2 559 92 00 Tel: +358-92 514 4221 (Suomija)

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Tel.: +359-(0)2 962 30 49 Tél/Tel: +32-(0)2 559 92 00

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: +420-221 773 411 Tel.: +36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: +45-32 46 24 00 Tel: +356-21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: +49-(0)2173 48 48 48 Tel: +31-(0)76-573 11 40

Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: +358-92 514 4221 (Soome) Tlf: +45-32 46 24 00

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: +30-2109974000 Tel: +43-(0)1 291 80 00

España Polska
UCB Pharma S.A. UCB Pharma Sp. z o.o.
Tel: +34-91 570 34 44 Tel.: +48-22 696 99 20

France Portugal
UCB Pharma S.A. BIAL-Portela & Cª, S.A.
Tél: +33-(0)1 47 29 44 35 Tel: +351-22 986 61 00

Hrvatska România
Medis Adria d.o.o. UCB Pharma România S.R.L.
Tel: +385-(0)1 230 34 46 Tel: +40-21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: +353-(0)1-4637 395 Tel: +386-1 589 69 00

Ísland Slovenská republika
UCB Nordic A/S UCB s.r.o., organizačná zložka
Sími: +45 / 32 46 24 00 Tel: +421-(0)2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: +39-02 300 791 Puh/Tel: +358-92 514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: +357-22 05 63 00 Tel: +46-(0)40 29 49 00

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Patient Information Leaflet: Information for the user

Neupro 2 mg/24 h transdermal patch

Rotigotine
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Neupro is and what it is used for
What you need to know before using Neupro
How to use Neupro
Possible side effects
How to store Neupro
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 class of medicines called "dopamine agonists". Dopamine is a substance in the brain involved in transmitting signals, and plays an important role in movement.
What Neupro is used for
Neupro is indicated in adults for the treatment of the signs and symptoms of:

Parkinson's disease – Neupro may be used alone or in combination with another medicine called levodopa.
Restless legs syndrome – this condition may be associated with discomfort in the legs and arms, an irresistible urge to move the legs, sleep disturbances, and feelings of fatigue or daytime sleepiness. Treatment with Neupro reduces these symptoms and decreases their duration.

2. What you should know before using Neupro

Do not take Neupro if:

you are allergic to rotigotine or to any of the other ingredients of this medicine (listed in section 6)
you are due to undergo a magnetic resonance imaging (MRI) examination (diagnostic imaging of the body's interior using magnetic fields instead of X-rays)
you are due to undergo "cardioversion" (a specific treatment for an abnormal heart rhythm).

Immediately before undergoing magnetic resonance imaging (MRI) or cardioversion,
you must remove the Neupro patch to avoid skin burns, as the patch contains aluminum.
You may then apply a new patch afterwards.
If any of the conditions listed above apply to you, do not use Neupro. If you have any doubts, consult your
doctor or pharmacist first.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Neupro. This is because:

your blood pressure should be monitored regularly while using Neupro, especially at the beginning of treatment. Neupro can affect blood pressure.
your eyes should be checked regularly while using Neupro. If you notice any vision problems between check-ups, contact your doctor immediately.
if you have severe liver problems, your doctor may consider adjusting your dose. If your liver problems worsen during treatment, contact your doctor immediately.
skin reactions caused by the patch may occur – see “Skin reactions caused by the patch” in section 4.
you may feel very sleepy or fall asleep suddenly – see “Driving and using machines” in section 2.
involuntary muscle contractions may occur, causing abnormal movements or postures, often repetitive (dystonia), abnormal posture, or lateral bending of the spine (also known as pleurothotonus or Pisa syndrome). If this occurs, your doctor may need to adjust your treatment.
symptoms of Restless Legs Syndrome may start earlier than usual, become more intense, or affect other limbs. If you experience such symptoms before or after starting Neupro treatment, contact your doctor, as your treatment may need to be adjusted. Medicines used to treat Parkinson’s disease and Restless Legs Syndrome must be reduced or discontinued gradually. Inform your doctor if, after stopping or reducing Neupro treatment, you experience symptoms such as depression, anxiety, fatigue, sweating, or pain. Loss of consciousness may occur Neupro may cause loss of consciousness. This is particularly likely when you first start using Neupro or when the dose is increased. Inform your doctor if you lose consciousness or feel dizzy. Changes in behaviour and abnormal thinking Neupro may cause side effects that affect your behaviour (the way you act). It may be helpful to inform a family member or caregiver that you are taking this medicine and ask them to read this leaflet. In this way, a family member or caregiver can alert you or your doctor if they are concerned about any changes in your behaviour. These include:
a strong desire for high doses of Neupro or other medicines used to treat Parkinson’s disease and Restless Legs Syndrome
unusual urges or desires that you cannot resist, which could harm you or others – symptoms are mainly seen in patients with Parkinson’s disease
abnormal thoughts and behaviour – most cases occur in patients with Parkinson’s disease. See “Changes in behaviour and abnormal thinking” in section 4 for more information.

Children and adolescents
Do not administer this medicine to children under 18 years of age, as the safety and efficacy of the medicine in this age group have not been established.
Other medicines and Neupro
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes non-prescription medicines or herbal remedies.
If you are being treated with both Neupro and levodopa, some side effects may worsen. These include seeing or hearing things that are not real (hallucinations), involuntary movements related to Parkinson’s disease (dyskinesia), and swelling in the legs and feet.
While using Neupro, do not take the following medicines – because they may reduce its effect:

“antipsychotic” medicines – used to treat certain mental disorders
metoclopramide – used for nausea (feeling unwell) and vomiting. Inform your doctor before using Neupro if you are taking:
sedative medicines such as benzodiazepines or medicines used to treat mental disorders or depression
medicines that lower blood pressure. Neupro can reduce blood pressure when standing up – this effect may be worsened by medicines used to lower blood pressure. Your doctor will advise whether it is safe for you to continue taking these medicines while using Neupro. Neupro with food, drinks and alcohol Since rotigotine enters the bloodstream through the skin, food and drinks have no effect on how the medicine is absorbed by the body. Consult your doctor about whether you may drink alcohol while using Neupro. Pregnancy and breastfeeding Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn child are unknown. Do not breastfeed while being treated with Neupro. This is because rotigotine may pass into breast milk and affect the baby. In addition, a reduction in the amount of milk produced is likely. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Driving and using machines Neupro may cause severe drowsiness and may cause you to fall asleep suddenly. If this happens, do not drive. In isolated cases, patients have fallen asleep while driving vehicles, resulting in accidents. Also, if you feel very drowsy, do not use tools or machinery – or engage in any other activity that could put you or others at risk of serious injury. Neupro contains sodium metabisulfite (E223) Sodium metabisulfite (E223) may, rarely, cause severe hypersensitivity reactions (allergic reactions) and bronchospasm (breathing problems caused by narrowing of the airways).