Prospecto: information for the user

Neupro 2mg/24h transdermal patch

Rotigotine

Read this prospect carefully before starting to use the medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Content of theprospect:

1. What Neupro is and for what it is used
2. What you need to know before starting to use Neupro
3. How to use Neupro
4. Possible adverse effects
5. Storage of Neupro
6. Contents of the package and additional information

What is Neupro

Neupro contains the active ingredient rotigotine.

It belongs to a group of medicines known as “dopamine agonists”. Dopamine is an important messenger in the brain for movement.

What is Neupro used for

Neupro is used in adults to treat the symptoms of:

• Parkinson's Disease- Neupro may be used alone or with another medicine called levodopa.
• Restless Legs Syndrome(RLS) – this syndrome may be associated with leg or arm discomfort, urge to move, sleep disturbances, and feelings of fatigue or daytime sleepiness. Treatment with Neupro reduces or decreases the duration of these symptoms.

Do not use Neupro if:

• You areallergicto rotigotine or any of the othercomponentsof this medication (listed in section 6)
• You are going to have amagnetic resonance imaging (MRI) scan(diagnostic images of the inside of the body, created using magnetic energy instead of X-ray energy)
• You need acardioversion(specific treatment for heart rhythm disturbances)

Remove the Neupro patch just before undergoing an MRI or cardioversion to avoid skin burns, as the patch contains aluminum. You can put a new patch on after these tests are completed.

Do not use Neupro if any of the above options occur. If unsure, consult your doctor, pharmacist, or nurse first.

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to use Neupro, as:You must control your blood pressure periodically while using Neupro, especially at the beginning of treatment. Neupro may affect your blood pressure.
• Yourvisionshould be checked periodically while using Neupro. If you notice any vision problems between check-ups, inform your doctor immediately.
• If you havesevere liver problems, your doctor may need to adjust the dose. If your liver problems worsen during Neupro treatment, inform your doctor as soon as possible.
• You may experienceskin reactionscaused by the patch – see ‘Skin problems caused by the patch’ in section 4.
• You may feelextremely drowsy or fall asleep suddenly– see ‘Driving and operating machines’ in section 2.
• You may experience involuntary muscle contractions that cause abnormal movements or postures, often repetitive (dystonia), abnormal postures, or lateral flexion of the back (also known as pleurostotonos or Pisa syndrome). If this occurs, your doctor may decide to adjust your medication.
• The symptoms ofRestless Legs Syndromemay start before treatment, be more intense, and involve other parts of the body. If you experience these symptoms before or after starting Neupro treatment, contact your doctor as your treatment may need to be adjusted.

Medications used to treat Parkinson's disease and Restless Legs Syndrome should be gradually reduced or discontinued. Inform your doctor if you experience symptoms such as depression, anxiety, fatigue, sweating, or pain after stopping or reducing Neupro treatment.

You may experience loss of consciousness

Neupro may cause loss of consciousness, especially when starting treatment or increasing the dose. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Neupro may produce adverse effects that change your behavior (how you act). If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to inform a family member or caregiver that you are using this medication and have them read the leaflet.

This includes:

• Imperative need to consume large doses of Neupro or other medications used to treat Parkinson's disease and Restless Legs Syndrome
• Anxiety or imperative need to behave in an unusual manner, which you cannot control and may harm you or others – these symptoms are mainly observed in patients with Parkinson's disease
• Abnormal thoughts or behaviors – most of these symptoms appear more frequently in patients with Parkinson's disease.

For more information, see ‘Changes in behavior and abnormal thoughts’ in section 4.

Children and adolescents

This medicationshould not be administeredtochildrenunder 18 years of age, as its safety and efficacy in this age group are unknown.

Use of Neupro with other medications

Inform your doctor or pharmacist if you areusing,haveusedrecently or may need to use any other medication. This includes over-the-counter medications and herbal remedies.

If you are being treated with Neupro and levodopa at the same time, some adverse effects may worsen. This includes, seeing or hearing things that are not real (hallucinations), uncontrolled movements related to Parkinson's disease (dyskinesia), swelling in the legs and feet.

Do not take the following medications while using Neupro, as they may reduce its effect:

• ‘Antipsychotic’ medications – used to treat certain mental illnesses
• Metoclopramide – used to treat nausea and vomiting.

Consult your doctor before using Neupro if you are taking:

• Sedatives such as benzodiazepines or medications used to treat mental disorders or depression
• Medications that lower blood pressure. Neupro may lower blood pressure when standing up – this effect may worsen when taking medications to lower blood pressure.

Your doctor will inform you if it is safe to take these medications while using Neupro.

Use of Neupro with food, drinks, and alcohol

Since rotigotine enters the bloodstream through the skin, taking food or drinks does not affect how this medication is absorbed. Consult your doctor if 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 fetus are unknown.

Do not breastfeed during Neupro treatment. This is because rotigotine may pass into breast milk and affect your baby. It is also likely to reduce milk production.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Neupro may make you feel extremely drowsy and you may fall asleep suddenly. If this occurs, do not drive.

In isolated cases, some people have fallen asleep while driving, resulting in accidents.

Do not use tools or machines if you feel extremely drowsy – or perform any activity that may put you or others at risk of serious injury.

Neupro contains sodium metabisulfite (E223)

Neupro contains sodium metabisulfite (E223), a substance that rarely may cause severe allergic reactions and bronchospasm (difficulty breathing due to narrowing of the airways).

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

What dose of patch to use

The dose of Neupro you need depends on your condition – see below.

Neupro is available in patches of different doses that release the medication over 24 hours. The doses 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 1 mg/24 h and 3 mg/24 h patches are used for the treatment of Restless Legs Syndrome, while the 4 mg/24 h, 6 mg/24 h, and 8 mg/24 h patches are used for the treatment of Parkinson's disease. The 2 mg/24 h patches are used for the treatment of Parkinson's disease and Restless Legs Syndrome.

• You may need to use more than one patch to achieve the prescribed dose.
• To doses above 8 mg/24 h (doses prescribed by your doctor above the available doses), use multiple patches to achieve the final dose. For example, a daily dose of 10 mg can be achieved by using a 6 mg/24 h patch and a 4 mg/24 h patch.
• The patches cannot be cut into pieces.

Treatment of Parkinson's disease

Patients not taking levodopa – early stages of Parkinson's disease

• Your starting dose will be a 2 mg/24 h patch per day.
• From the second week, the daily dose will be increased by 2 mg weekly – until you reach the appropriate maintenance dose for you.
• For most patients, the appropriate dose is between 6 mg and 8 mg per day. This is usually achieved between 3 and 4 weeks.
• The maximum dose is 8 mg per day.

Patients taking levodopa – advanced stages of Parkinson's disease

• Your starting dose will be a 4 mg/24 h patch per day.
• From the second week, the daily dose will be increased by 2 mg weekly – until you reach the appropriate maintenance dose for you.
• For most patients, the appropriate dose is between 8 mg and 16 mg per day. This is usually achieved between 3 and 7 weeks.
• The maximum dose is 16 mg per day.

Treatment of Restless Legs Syndrome

• Your starting dose will be a 1 mg/24 h patch per day.
• From the second week, the daily dose will be increased by 1 mg weekly – until you reach the appropriate maintenance dose for you. This is when you and your doctor confirm that your symptoms are adequately controlled and that the side effects of the medication are acceptable.
• The maximum dose is 3 mg per day.

If you have to stop taking this medication, see “Stopping treatment with Neupro”in section 3.

How to use the Neupro patches

Neupro is a patch that is applied to the skin.

• Check that the used patch has been removed before putting on a new one.
• Put the new patch on a different area of the skin each day.
• Leave the patch on the skin for 24 hours, then remove it and put on a new one.
• Change the patchapproximately at the same time every day.
• Do not cut the Neupro patches into pieces.

Where to put the patch

If you continue to have skin problems caused by the patch, see “Skin problems caused by the patch” in section 4 for more information.

To prevent the patch from peeling off or falling off

• Do notput the patch in an area where it may be subjected tofriction from tight clothing.
• Do notusecreams, oils, lotions, powdersor any otherskin productwhere you will be putting the patch. Nor on top of or near another patch that you are already using.
• If you need to put a patch on an area of the skin where you have hair, at least3 days beforeputting it on that site, you shouldshave(depilate) the skin area.
• If the edges of the patch start to peel off, you can use adhesive tape to hold the patch in place.

If the patch falls off, you should put a new one on for the rest of the day and the next day, and put a new patch on at the usual time.

• You shouldavoidheating the area of thepatch– for example, too much sunlight, saunas, hot baths, or hot water bottles. This is because the medication may be released too quickly. If you think it has gotten too hot, contact your doctor or pharmacist.
• Always check that the patchhas not fallen off after activities such asbathing, showering, or exercising.
• If the patch hasirritated your skin, you shouldkeep the irritated areaprotected from direct sunlight. This is because exposure to sunlight may cause changes in the skin color.

How to use the patch

• Each patch is individually packaged in a sachet.
• Before opening the sachet, you should decide where you will put the new patch and check thatthe used patch has been removed.
• When you have opened the sachet and removed the disposable cover from the patch, you should put the patch on the skin immediately.

How to remove the used patch

• Remove the used patch slowly and carefully.
• Gently wash the area with warm water and a mild soap. This will remove any remaining adhesive from the skin. You can also use a small amount of baby oil to remove any remaining adhesive.
• Do not use alcohol or other solvents – such as nail polish remover. This could

irritate your skin.

Using more Neupro than you should

Using higher doses of Neupro than your doctor has prescribed can cause side effects such as nausea or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), confusion, extreme drowsiness, involuntary movements, and seizures.

Report this to your doctor or go to the hospital as soon as possible. They will tell you what to do.

Forgetting 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. Remove the used patch and put on a new one.
• If you have forgotten to put on a new patch after removing the used one, as soon as you remember, put on a new one.

In both cases, the next day put on a new patch at the usual time. Do not use a double dose to make up for the missed doses.

Stopping treatment with Neupro

Do not stop using Neupro without first consulting your doctor. Sudden discontinuation may cause a condition called malignant neuroleptic syndrome, which can put your life at risk. The signs include: loss of muscle movement (akinesia), muscle stiffness, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, and decreased consciousness (e.g., coma).

If your doctor tells you to stop treatment with Neupro, thedaily doseof Neupro should begradually reduced:

• Parkinson's disease– should be reduced by 2 mg every 2 days.
• Restless Legs Syndrome– should be reduced by 1 mg every 2 days.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Inform your doctor, pharmacist, or nurse if you notice any side effects.

Most likely side effects at the start of treatment

You may experiencenauseaandvomitingat the start of treatment. These side effects are usually mild or moderate and do not last long. You shouldconsult your doctorif the side effects last a long time or if they worry you.

Skin problems caused by the patch

• You may experience redness and itching in the area of the skin where the patch has been applied – these reactions are usually mild or moderate.
• These reactions usually disappear a few hours after removing the patch.
• Consult your doctorif you have a skin reaction that lasts more than a few days, is severe, or spreads outside the area covered by the patch.
• Avoid exposure to the sun and tanning beds in areas of skin that show any type ofreaction caused by the patch.
• To help prevent skin reactions, the patch should be applied to a different site each day, and only use the same area again after 14 days.

You may experience loss of consciousness

Neupro can cause loss of consciousness. This can happen especially when you start treatment with Neupro or when your dose is increased. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Inform your doctor if you notice any change in behavior, thought, or both, as indicated below.

Your doctor will tell you how to manage or reduce the symptoms.

If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to tell a family member or caregiver that you are using this medicine and to read the leaflet. Neupro can cause anxiety or an urgent need to behave in an unusual way and not be able to control the impulse, attack, or temptation to perform certain actions that may harm you or others – these symptoms are mainly seen in patients with Parkinson's disease.

These actions may include:

• Strong addiction to games of chance – even seriously affecting you or your family
• Altered or increased sexual interest and behavior that causes great concern for you and others – for example, increased sexual desire
• Uncontrolled purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal or more than needed to satisfy your appetite).

Neupro can cause other abnormal behaviors and thoughts, which may include:

• Abnormal thoughts about reality
• Delusions and hallucinations (seeing or hearing things that are not real)
• Confusion
• Disorientation
• Aggressive behavior
• Agitation
• Delirium.

Inform your doctor if you notice any change in your behavior, thought, or both, as indicated above.

Your doctor will tell you how to manage or reduce the symptoms.

Allergic reactions

Inform your doctor if you notice signs of an allergic reaction – which may include swelling of the face, tongue, or lips.

Side effects if using Neupro for Parkinson's disease

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

• Headache
• Drowsiness or dizziness
• Nausea, vomiting
• Irritations of the skin in the area of application of the patch, such as redness and itching

Common: may affect up to 1 in 10 patients

• Falls
• Hypo
• Weight loss
• Swelling in the legs and feet
• Feeling of weakness (fatigue), feeling tired
• Increased heart rate (palpitations)
• Constipation, dry mouth, stomach discomfort
• Redness, increased sweating, itching
• Dizziness (sensation of spinning)
• Seeing or hearing things that are not real (hallucinations)
• Low blood pressure when standing up, high blood pressure
• Difficulty falling asleep, sleep disorders, difficulty sleeping, nightmares, unusual dreams
• Involuntary movements related to Parkinson's disease (dyskinesia)
• Loss of consciousness, dizziness when standing up caused by low blood pressure
• Inability to control the impulse to perform a harmful action, including addiction to games of chance, repetitive actions without sense, compulsive purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon: may affect up to 1 in 100 patients

• Blurred vision
• Weight gain
• Allergic reaction
• Low blood pressure
• Increased heart rate
• Increased sexual desire
• Abnormal heart rhythm
• Stomach discomfort and pain
• Generalized itching, skin irritation
• Sudden falling asleep without warning
• Inability to achieve or maintain an erection
• Feeling agitated, disoriented, confused, or paranoid
• Abnormal liver test results or elevated liver test results
• Visual disturbances such as seeing colors or lights
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme mainly found in skeletal muscles)

Rare: may affect up to 1 in 1,000 patients

• Delusions
• Delirium
• Feeling irritable
• Aggressive behavior
• Psychotic disorders
• Eruption in wide areas of the body
• Involuntary muscle spasms (convulsions)

Unknown: does not know how often they occur

• Anxiety from taking high doses of medicines like Neupro – more than needed for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of Neupro
• Diarrhea
• Head drop syndrome
• Rhabdomyolysis (a rare severe muscle disorder that causes muscle pain, sensitivity, and weakness and may cause kidney problems)

Inform your doctor, pharmacist, or nurse if you experience any of these side effects.

Side effects if using Neupro for Restless Legs Syndrome

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

• Headache
• Nausea
• Feeling of weakness (fatigue)
• Irritations of the skin in the area of application of the patch, such as redness and itching

Common: may affect up to 1 in 10 patients

• Itching
• Feeling irritable
• Allergic reaction
• Increased sexual desire
• Increased blood pressure
• Vomiting, stomach discomfort
• Swelling in the legs and feet
• Drowsiness, sudden falling asleep without warning, difficulty sleeping, sleep disorders, unusual dreams
• Inability to control the impulse to perform a harmful action, including addiction to games of chance, repetitive actions without sense, compulsive purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon: may affect up to 1 in 100 patients

• Feeling agitated
• Dizziness when standing up caused by low blood pressure

Rare: may affect up to 1 in 1,000 patients

• Aggressive behavior
• Disorientation

Unknown: does not know how often they occur

• Anxiety from taking high doses of medicines like Neupro – more than needed for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of Neupro.
• Seeing or hearing things that are not real (hallucinations)
• Nightmares
• Paranoia
• Confusion
• Psychotic disorders
• Delusions
• Delirium
• Dizziness
• Loss of consciousness, involuntary movements (dyskinesia)
• Involuntary muscle spasms (convulsions)
• Blurred vision
• Visual disturbances such as seeing colors or lights
• Dizziness (sensation of spinning)
• Increased heart rate (palpitations)
• Abnormal heart rhythm
• Low blood pressure
• Hypo
• Constipation, dry mouth
• Stomach discomfort and pain
• Diarrhea
• Redness, increased sweating
• Generalized itching, skin irritation
• Eruption in wide areas of the body
• Inability to achieve or maintain an erection
• Weight loss, weight gain
• Abnormal liver test results or elevated liver test results
• Increased heart rate
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme mainly found in skeletal muscles)
• Falls
• Rhabdomyolysis (a rare severe muscle disorder that causes muscle pain, sensitivity, and weakness and may cause kidney problems)

Inform your doctor or pharmacist if you experience any of these side effects.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the carton box.

Do not store above 86°F (30°C).

What to do with used and unused patches

• Used patches still contain the active ingredient, 'rotigotine', which can be hazardous to others. Fold the used patch with the adhesive side inward. Place the patch in the original package and then dispose of it in a safe place, out of children's reach.

• Do not dispose of medications through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofNeupro

The active ingredient is rotigotine.

• One patch releases 2mg of rotigotine every 24hours. Each patch of 10cm2contains 4.5mg of rotigotine.

The other components are:

• Polysiloxane, trimethylsilyl silicate copolymer, povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL‑α‑tocopherol (E307).
• Protective layer:Aluminum-coated polyester film, siliconized, colored with a layer of pigment (titanium dioxide (E171), yellow pigment 13, red pigment 166, yellow pigment 12) and printed (red pigment 146, yellow pigment 180, black pigment 7).
• Disposable coating:Transparent polyester film coated with fluoropolymer.

Appearance of the product and contents of the package

Neupro is a transdermal patch. It is thin and has three layers. It is square in shape with rounded corners. The outer part is brown and has the imprint "Neupro 2mg/24h."

Neupro is available in the following formats:

Cartons containing 7, 14, 28, 30 or 84 (carton containing 3 packs of 28)patches, each patch is included in an individual envelope.

Only some package sizes may be marketed.

Marketing Authorization Holder

UCB Pharma S.A.

Allée de la Recherche 60

B-1070 Brussels

Belgium

Responsible for manufacturing

UCB Pharma S.A.

Chemin du Foriest

B-1420 Braine l’Alleud

Belgium

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency

at https://www.ema.europa.eu