Package Insert: 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 this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

What is Neupro

Neupro contains the active ingredient rotigotina.

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.

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 disorders)

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

Do not use Neupro if you experience any of the above. If you are unsure, talk to your doctor or pharmacist first.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Neupro, as:

• You mustmonitor your blood pressureperiodically while using Neupro, especially at the beginning of treatment. Neupro may affect your blood pressure.

• You musthave your eyes checkedperiodically while using Neupro. If you notice any eye 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 mayfeel very 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 called pleurostotonos or Pisa syndrome). If this happens, your doctor may decide to adjust your medication.

If you experience these symptoms after starting Neupro treatment, contact your doctor.

You may lose consciousness

Neupro may cause loss of consciousness. This can happen especially when starting Neupro treatment or when 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 tell a family member or caregiver that you are using this medication and have them read the leaflet.

This includes:

• anxiety or an urgent need to behave in an unusual way, which you cannot control and which may harm you or others

• abnormal thoughts or behaviors.

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

Children and adolescents

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

Using Neupro with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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, see or hear 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 illnesses 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.

Using 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 very drowsy and may cause you to fall asleep suddenly. If this happens, do not drive. In rare cases, some people have fallen asleep while driving, which has caused accidents.

Do not use tools or machines if you feel very 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 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 need to use more than one patch to achieve the prescribed dose by your doctor.

• For doses above 8 mg/24 h (doses prescribed by your doctor above the available doses), several patches must be used to achieve the final dose. For example, the daily dose of 10 mg can be achieved by using a patch of 6 mg/24 h and a patch of 4 mg/24 h.

• The patches cannot be cut into pieces.

Treatment of Parkinson's Disease

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

• Your starting treatment dose will be a patch of 2 mg/24 h per day.

• From the second week, the daily dose will be increased by 2 mg weekly – until reaching 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 treatment dose will be a patch of 4 mg/24 h per day.

• From the second week, the daily dose will be increased by 2 mg weekly – until reaching 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.

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

How to use 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 adifferent 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 patchapproximatelyat the same time every day.
• Do not cut Neupro patches into pieces.

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 on an area where it may be subject tofriction from tight clothing.

• Do notusecreams, oils, lotions, powdersor any otherskin productwhere you are going toput 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 come loose, you can stick the patch with adhesive tape.

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

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

How to use the patch

• Each patch is individually packaged in a sachet.

• Before opening the sachet, you must decide where you are going to put the new patch and check that the used patch has been removed.

• When you have opened the sachet and removed the disposable cover from the patch, you must put the patch on the skin immediately.

How to remove the used patch

• Remove the used patch slowly and carefully.

• Wash the area gently with warm water and a mild soap. This way, you will remove any remaining adhesive residue on the skin. You can also use a small amount of baby oil to remove any remaining adhesive residue.

• Do not use alcohol or other solvents – such as nail polish remover. This could irritate your skin.

If you use more Neupro than you should

Using higher doses of Neupro than prescribed by your doctor 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.

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

If you forgot to change the patch at your usual time

• If you forgot 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 forgot to put on a new patch after removing the used patch, 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 compensate for the missed doses.

Stopping treatment with Neupro

Do not stop using Neupro without consulting your doctor. Sudden discontinuation could cause a condition called ‘neuroleptic malignant syndrome’ that could put your life at risk. The signs include: loss of muscle movement (akinesia), muscle rigidity, 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 must begradually reduced:

• Parkinson's disease– must be reduced by 2 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 or pharmacist 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 beyond the area covered by the patch.
• Avoid exposure to the sun and sunlamps in areas of skin that show any type of reaction caused by the patch.
• To help prevent skin reactions, you should put the patch in a different place 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 actions may include:

• Strong addiction to gambling – 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
• Restlessness
• 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 ofcansancio
• Increased heart rate (palpitations)
• Constipation, dry mouth, stomach pain
• Redness, increased sweating, itching
• Dizziness (sensación de dar vueltas)
• Seeing or hearing things that are not real (alucinaciones)
• Low blood pressure when standing up, high blood pressure
• Difficulty falling asleep, sleep disorders, difficulty sleeping, nightmares, strange dreams
• Movements related to Parkinson's disease (discinesia)
• Loss of consciousness, feeling dizzy when standing up caused by low blood pressure
• Difficulty controlling the impulse to perform a harmful action, including addiction to gambling, 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
• Falling asleep suddenly without warning
• Difficulty achieving or maintaining an erection
• Feeling agitated, disoriented, confused, or paranoid
• Abnormal liver test results or elevated
• Visual disturbances such as seeing colors or lights
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme that is mainly found in skeletal muscles).

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

• Delusions
• Delirium
• Feeling irritable
• Aggressive behavior
• Psychotic disorders
• Eruptions on large areas of the body
• Involuntary muscle spasms (convulsions)

Not known:does not know how often they occur

• Anxiety about taking high doses of medication such as 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
• Diarrea
• Head drop syndrome
• Rhabdomyolysis (a rare and serious 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.

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 at a temperature above 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 empty containers and unused medications. This will help protect the environment.

Composition of Neupro

The active ingredient is rotigotine.

• 4 mg/24 h:

A patch releases 4 mg of rotigotine every 24 hours. Each patch of 20 cm2contains 9.0 mg of rotigotine.

• 6 mg/24 h:

A patch releases 6 mg of rotigotine every 24 hours. Each patch of 30 cm2contains 13.5 mg of rotigotine.

• 8 mg/24 h:

A patch releases 8 mg of rotigotine every 24 hours. Each patch of 40 cm2contains 18.0 mg of rotigotine.

The other components are:

• Polysiloxane, trimethylsilyl silicate copolymer, povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
• Backing layer: Polyester film, siliconized, aluminumized, 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 has a square shape with rounded corners. The outer part is brown and has the imprint Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/24 h.

Neupro is available in the following formats:

Carton packs containing 7, 14, 28, 30 or 84 (multi-pack containing 3 packs of 28) patches, each patch is included in an individual sachet.

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 date of revision of this leaflet:

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agencyhttps://www.ema.europa.eu