NEUPRO 2 mg/24h TRANSDERMAL PATCH

Introduction

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.

Contents of the pack:

1. What is Neupro and what is it used for
2. What you need to know before you use Neupro
3. How to use Neupro
4. Possible side effects
5. Storing Neupro
6. Contents of the pack and other information

1. What is Neupro and what is it used for

What is Neupro

Neupro contains the active substance 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 signs and symptoms of:

• Parkinson's disease- Neupro can be used alone or with another medicine called levodopa.
• Restless Legs Syndrome (RLS)– this syndrome can be associated with discomfort in the legs or arms, a need to move, sleep disturbances, and a feeling of tiredness or sleepiness during the day. Treatment with Neupro reduces or decreases the duration of these symptoms.

2. What you need to know before you use Neupro

Do not use Neupro if:

• you are allergicto rotigotineor any of the other ingredientsof this medicine (listed in section 6)
• you are going to have a magnetic resonance imaging(MRI) scan (diagnostic images of the inside of the body, created using magnetic energy instead of X-ray energy)
• you need a cardioversion(specific treatment for heart rhythm disturbances).

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

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

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before you start using Neupro, as you should have your blood pressurechecked regularly while you are using Neupro, especially at the start of treatment. Neupro may affect your blood pressure.
• you should have your eyesightchecked regularly while you are using Neupro. If you notice any problems with your eyesight between checks, you should tell your doctor immediately.
severe liver problems, your doctor may need to adjust your dose. If your liver problems get worse while you are using Neupro, you should tell your doctor as soon as possible.
• you may have skin reactionscaused 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.
• the symptoms of Restless Legs Syndromemay start earlier than usual, be more intense, and involve other parts of the body. If you experience these symptoms before or after starting treatment with Neupro, contact your doctor as you may need to have your treatment adjusted.

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

You may lose consciousness

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

Changes in behavior and abnormal thoughts

Neupro can cause side effects that change your behavior (the way 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 medicine and for them to read this leaflet.

This includes:

• a strong desire to take large doses of Neupro or other medicines used to treat Parkinson's disease and Restless Legs Syndrome
• anxiety or a strong desire to behave in a way that is unusual for you and that you cannot control, which may harm you or others – these symptoms are mainly seen in patients with Parkinson's disease
• abnormal thoughts or behavior – most of these symptoms occur 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 medicine must notbe given to childrenunder 18 years because its safety and efficacy in this age group are not known.

Using Neupro with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines without a prescription and herbal medicines.

If you are being treated with Neupro and levodopa at the same time, some side effects may get worse. 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 medicines while you are using Neupro, as they may reduce its effect:

• ‘antipsychotic’ medicines - used to treat certain mental illnesses
• metoclopramide - used to treat nausea and vomiting.

Talk to 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 may lower blood pressure when standing up - this effect may be worse if you are taking medicines to lower blood pressure.

Your doctor will tell you if it is safe to take these medicines while you are 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 medicine is absorbed. You should talk to 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 unborn child are not known.

Do not breastfeed while you are using Neupro. This is because rotigotine may pass into breast milk and affect your baby. It is also likely to reduce the amount of milk produced.

If you are pregnant or breastfeeding, 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 can make you feel very sleepy, and you may fall asleep suddenly. If this happens, do not drive.

In rare cases, some people have fallen asleep while driving, which has led to accidents.

Also, do not use tools or machines if you feel very sleepy - or perform any activity in which you may put yourself or others at risk of serious injury.

Neupro contains sodium metabisulfite (E223)

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

3. How to use Neupro

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

Which patch dose to use

The dose of Neupro you need depends on your disease - 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 in 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 by your doctor.
• For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available doses), several patches should be used 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 who are not taking levodopa - initial 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 the appropriate maintenance dose for you is reached.
• 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 who are 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 the appropriate maintenance dose for you is reached.
• 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 the maintenance dose appropriate for you is reached. This is when you and your doctor confirm that your symptoms are adequately controlled and the adverse effects of the medication are acceptable.
• The maximum dose is 3 mg per day.

If you need to stop taking this medication, see "If you stop treatment with Neupro" in section 3.

How to use Neupro patches

Neupro is a patch that is applied to the skin.

• Make sure you have removed the used patch before putting on a new one.
• Place the new patch on a different area of 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 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 coming off or detaching

• Do notplace the patch in an area where it may be subject to friction from tight clothing.
• Do notuse creams, oils, lotions, powdersor any other skin productwhere you will place the patch. Nor on top of or near another patch that you are already using.
• If you need to place a patch on an area of skin where you have hair, at least 3 days beforeplacing it on that site, you should shave(depilate) the skin area.
• If the edges of the patch come off, you can secure the patch with tape.

If the patch falls off, you should 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 should avoidthat the patch area gets heated- for example, too much sunlight, saunas, hot baths, or hot water bottles. This is because the medication could be released more quickly. If you think you have overheated, 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, you should keepthe irritated area protected from direct sunlight.This is because sun exposure could cause changes in skin color.

How to use the patch

• Each patch is individually packaged in a pouch.
• Before opening the pouch, decide where you will place the new patch and check that you have removed the used patch.
• When you have opened the pouch and removed the disposable layer of the patch, you should immediately place the patch on your skin.

How to remove the used patch

• Remove the used patch slowly and carefully.
• Gently wash the area with warm water and mild soap. This will remove any remaining adhesive from the skin. You can also
• use a little baby oil to remove any remaining adhesive.
• Do not use alcohol or other liquid 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 your doctor has indicated may cause adverse effects such as nausea or vomiting, decreased blood pressure, seeing or hearing things that are not real (hallucinations), confusion, excessive drowsiness, involuntary movements, and convulsions.

In these cases, inform your doctor or go to the hospital as soon as possible. They will indicate what you should do.

If you forget to change the patch at the usual time

• If you have forgotten to change the patch at the 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 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 make up for the missed doses.

If you stop treatment with Neupro

Do not stop using Neupro without first consulting your doctor. A sudden interruption could cause a condition called 'neuroleptic malignant syndrome' that 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, decreased consciousness (e.g., coma).

If your doctor indicates that you should stop treatment with Neupro, the daily doseof Neupro should be gradually reduced:

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Inform your doctor, pharmacist, or nurse if you notice any adverse effect.

Most Likely Adverse Effects at the Start of Treatment

You may experience nauseaand vomiting at the start of treatment. These effects are usually mild or moderate and last for a short time. You should consult your doctorif the effects last for a long time or if they worry you.

Skin Problems Caused by the Patch

• You may experience redness and itching in the skin area 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 for more than a few days, if it is severe, or if it spreads beyond the area covered by the patch.
• Avoid exposure to the sun and sunlamps in skin areas that show any type of reaction caused by the patch.
• To help prevent skin reactions, the patch should be placed on a different site each day, and the same area should only be used again after 14 days.

You May Experience Loss of Consciousness

Neupro can cause loss of consciousness. This can happen especially when starting treatment with Neupro or when increasing the dose. 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 indicate 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 have them read the leaflet. Neupro can cause anxiety or an overwhelming need to behave abnormally and be unable to control the impulse, attack, or temptation to perform certain actions that can harm you or others – these symptoms are mainly observed in patients with Parkinson's disease.

These actions can 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 shopping or excessive spending
• episodes of binge eating (eating large amounts of food in a short period) 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 can include:

• abnormal thoughts about reality
• delusional ideas 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 indicate how to manage or reduce the symptoms.

Allergic Reactions

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

Adverse Effects if You Use Neupro for Parkinson's Disease

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

Very Common:can affect more than 1 in 10 patients

• headache
• drowsiness or dizziness
• nausea, vomiting
• skin irritation at the patch application site, such as redness and itching

Common:can affect up to 1 in 10 patients

• falls
• hypo
• weight loss
• swelling in the legs and feet
• feeling of weakness (fatigue), feeling of tiredness
• increased heart rate (palpitations)
• constipation, dry mouth, stomach burning
• redness, increased sweating, itching
• vertigo (feeling of spinning)
• seeing or hearing things that are not real (hallucinations)
• low blood pressure when standing up, high blood pressure
• difficulty staying asleep, sleep disorders, difficulty sleeping, nightmares, strange dreams
• involuntary movements related to Parkinson's disease (dyskinesia)
• loss of consciousness, sensation of dizziness when standing up due to low blood pressure
• inability to control the impulse to perform a harmful action, including addiction to gambling, repetitive actions without sense, compulsive shopping or excessive spending
• episodes of binge eating (eating large amounts of food in a short period), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon:can 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 sleepiness without warning
• inability to achieve or maintain 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 found mainly in skeletal muscles)

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

• delusional ideas
• delirium
• feeling of irritability
• aggressive behavior
• psychotic disorders
• rash on large areas of the body
• involuntary muscle spasms (convulsions)

Not Known:frequency not known

• anxiety about taking high doses of medicines like Neupro – more than necessary for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and can lead to excessive use of Neupro
• diarrhea
• dropped head syndrome
• rhabdomyolysis (a rare, severe muscle disorder that causes pain, sensitivity, and weakness of the muscles and can cause kidney problems)

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

Adverse Effects if You Use Neupro for Restless Legs Syndrome

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

Very Common:can affect more than 1 in 10 patients

• headache
• nausea
• feeling of weakness (fatigue)
• skin irritation at the patch application site, such as redness and itching

Common:can affect up to 1 in 10 patients

• itching
• feeling of irritability
• allergic reaction
• increased sexual desire
• increased blood pressure
• vomiting, stomach burning
• swelling in the legs and feet
• drowsiness, sudden sleepiness without warning, difficulty sleeping, sleep problems, unusual dreams
• inability to control the impulse to perform a harmful action, including addiction to gambling, repetitive actions without sense, compulsive shopping or excessive spending
• episodes of binge eating (eating large amounts of food in a short period), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon:can affect up to 1 in 100 patients

• feeling agitated
• feeling of dizziness when standing up due to low blood pressure

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

• aggressive behavior
• disorientation

Not Known:frequency not known

• anxiety about taking high doses of medicines like Neupro – more than necessary for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and can lead to excessive use of Neupro
• seeing or hearing things that are not real (hallucinations)
• nightmares
• paranoia
• confusion
• psychotic disorders
• delusional ideas
• delirium
• dizziness
• loss of consciousness, involuntary movements (dyskinesia)
• involuntary muscle spasms (convulsions)
• blurred vision
• visual disturbances such as seeing colors or lights
• vertigo (feeling 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
• generalized rash
• inability to achieve or maintain an erection
• weight loss, weight gain
• abnormal liver test results or elevated
• increased heart rate
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscles)
• falls
• rhabdomyolysis (a rare, severe muscle disorder that causes pain, sensitivity, and weakness of the muscles and can cause kidney problems)

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

Reporting Adverse Effects

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

5. Storage of Neupro

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

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

Do not store 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 envelope and then throw it away in a safe place, out of the reach of children.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Neupro

The active ingredient is rotigotine.

• One patch releases 2 mg of rotigotine every 24 hours. Each 10 cm2 patch contains 4.5 mg of rotigotine.

The other components are:

• Poly (dimethylsiloxane, trimethylsilyl silicate) copolymerized, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304), and DL-α-tocopherol (E307).
• Covering layer: Polyester film, siliconized, aluminized, colored with a pigment layer (titanium dioxide (E171), yellow pigment 95, and red pigment 166) and printed (red pigment 144, yellow pigment 95, and black pigment 7).
• Disposable coating: Transparent polyester film coated with fluoropolymer.

Appearance of the Product and Package Contents

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 in color and bears the inscription Neupro 2 mg/24 h.

Neupro is available in the following formats:

Packages containing 7, 14, 28, 30, or 84 (multiple package containing 3 packages of 28) patches, each patch is included in an individual envelope.

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website http://www.ema.europa.eu