NEUPRO 2, 4, 6, 8 mg/24h TRANSDERMAL PATCH

Introduction

Package Leaflet: Information for the User

Neupro 2 mg/24 h

Neupro 4 mg/24 h

Neupro 6 mg/24 h

Neupro 8 mg/24 h

Transdermal Patch

Ropinirole

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

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

• This medicine has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Neupro and what is it used for
2. What you need to know before using Neupro
3. How to use Neupro
4. Possible side effects
5. Storage of Neupro
6. Package contents and additional 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 Neupro is 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.

2. What you need to know before using Neupro

Do not use Neupro if:

• you are allergicto rotigotineor to 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 disorders).

You must remove the Neupro patch just before having an MRI scan or cardioversion to avoid skin burns due to the aluminum in the patch. You can apply 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 or pharmacist first.

Warnings and precautions

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

• you should have your blood pressurechecked regularly while using Neupro, especially at the start of treatment. Neupro may affect your blood pressure.

• you should have your eyesightchecked regularly while using Neupro. If you notice any problems with your eyesight between checks, you should tell your doctor immediately.

• if you have severe liver problems, your doctor may need to adjust the dose. If your liver problems get worse during treatment with 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.

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

You may lose consciousness

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

Changes in behavior and abnormal thoughts

Neupro may cause side 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 medicine and to read the package leaflet.

This includes:

• anxiety or an overwhelming urge to behave in a way that is unusual for you and that you cannot control and that 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 medicine must notbe given to childrenunder 18 years of age because its safety and efficacy in this age group are unknown.

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 using Neupro, as they may reduce its effect:

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

Consult 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 when taking medicines to lower blood pressure.

Your doctor will tell you if it is safe to take these medicines 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 medicine is absorbed. You should 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 treatment with 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Neupro may make you feel very sleepy and may cause you to fall asleep suddenly. If this happens, do not drive. In rare cases, 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 where 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 and bronchospasm (difficulty breathing due to narrowing of the airways).

3. How to use Neupro

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

What 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 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 necessary dose prescribed by your doctor.

The starting treatment package of Neupro contains 4 different packages (one of each concentration), each with 7 patches. These packages are usually needed during the first four weeks of treatment, but you may not use the entire package, depending on your response to Neupro, or you may need higher doses after week 4, which are not covered by this package.

On the first day of treatment, start using Neupro 2 mg (package marked with "Week1") and use a Neupro 2 mg transdermal patch every day. You should use Neupro 2 mg for 7 days (i.e., if you start on a Sunday, switch to the next dose on the following Sunday).

At the beginning of the second week, you should use Neupro 4 mg (package marked with "Week 2").

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

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

The suitable dose for you will depend on your needs.

A dose of 4 mg of Neupro per day may be effective in some patients. In most cases of early-stage Parkinson's disease, the suitable dose is achieved in 3 or 4 weeks, with doses of 6 mg/24 h or 8 mg/24 h, respectively. The maximum dose is 8 mg per day. In most cases of advanced Parkinson's disease, the correct dose is achieved between 3 to 7 weeks with doses of 8 mg per day up to a maximum dose of 16 mg per day. For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available doses), several patches should be used to achieve the final dose. For example, a daily dose of 14 mg is achieved by using a 6 mg/24 h patch and an 8 mg/24 h patch, or vice versa, and a dose of 16 mg is achieved by using two 8 mg/24 h patches.

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

How to use the Neupro patches

Neupro is a patch that is applied to the skin.

• Make sure you have removed the used 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 the patchapproximately at the same time every day.
• Do not cut the Neupro patches into pieces.

Where to place the patch

Place the adhesive side of the patch on clean, dry, and healthy skin in the following areas, as indicated in the gray areas of the drawing:

• Shoulder or upper arm.
• Abdomen.
• Sides (the sides between the ribs and hips).

• Thigh or hip.

To avoid skin irritation

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 detaching

• Do notplace the patch in an area where it may be subject to friction from tight clothing.

• Do notuse creams, oils, lotions, powders, or any other skin productwhere you will apply the patch. Nor should you use them 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 beforeapplying it to that site, you should shave(depilate) the skin area.

• If the edges of the patch peel off, you can secure the patch with adhesive tape.

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

• You should avoidheating the patch area- for example, excessive 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 from the patch, you should apply the patch to your skin immediately.

How to remove the used patch

• Remove the used patch slowly and carefully.

• Gently wash the area with lukewarm water and a 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, extreme 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 have used a different patch (e.g., Neupro 4 mg/24 h instead of Neupro 2 mg/24 h) than the one indicated by your doctor, inform your doctor or go to the hospital as soon as possible, and follow their instructions for changing the patches.

If you notice unpleasant reactions, consult your doctor.

If you forgot 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 apply a new one.

• If you have forgotten to apply a new patch after removing the used patch, as soon as you remember, apply a new one.

In both cases, the next day, apply 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.

If you have any other doubts 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 or pharmacist 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 you are concerned.

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 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 areas of the skin that show any reaction caused by the patch.

• To help prevent skin reactions, you should apply the patch to a different site each day and only reuse the same area 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

Tell 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 to read the package insert. 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 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 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 may include:

• abnormal thoughts about reality

• delusional ideas and hallucinations (seeing or hearing things that are not real)
• confusion

• disorientation

• aggressive behavior
• agitation

• delirium.

Tell 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

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

Adverse Effects if You Use Neupro for Parkinson's Disease

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

Very Common: may 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: may 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, feeling of dizziness when standing up due to a drop in blood pressure

• inability to control the impulse to perform a harmful action, including addiction to gambling, repetitive actions, 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: may affect up to 1 in 100 patients

• blurred vision
• weight gain
• allergic reaction

• drop in blood pressure

• increased heart rate
• increased sexual desire
• abnormal heart rhythm

• stomach discomfort and pain

• generalized itching, skin irritation

• suddenly falling asleep 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 muscle).

Rare: may 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

• muscle spasms (convulsions)

Unknown: 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)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this package insert. 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 stated 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.

2 mg/24 h:

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

4 mg/24 h:

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

6 mg/24 h:

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

8 mg/24 h:

A patch releases 8 mg of rotigotine every 24 hours. Each 40 cm2 patch contains 18.0 mg of rotigotine.

The other ingredients are:

Poly (dimethylsiloxane, trimethylsilyl silicate) copolymer, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304), and DL-α-tocopherol (E307).

Covering layer: Polyester film, siliconized, aluminum-coated, 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 liner: 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 layer is brown in color and bears the inscription Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, or 8 mg/24 h.

Neupro is available in the following formats:

The starter pack contains 28 transdermal patches in 4 packs, each containing 7 patches of 2 mg, 4 mg, 6 mg, or 8 mg, each patch is included in an individual envelope.

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:

België/Belgique/BelgienLietuva

UCB Pharma SA/NV UCB Pharma Oy Finland

Tél/Tel: +32-(0)2 559 92 00 Tel: +358-92 514 4221 (Suomija)

????????Luxembourg/Luxemburg

? ?? ?? ???????? ???? UCB Pharma SA/NV

Te?.: +359-(0)2 962 30 49 Tél/Tel: +32-(0)2 559 92 00

Ceská republikaMagyarország

UCB s.r.o. UCB Magyarország Kft.

Tel: +420-221 773 411 Tel.: +36-(1) 391 0060

DanmarkMalta

UCB Nordic A/S Pharmasud Ltd.

Tlf: +45-32 46 24 00 Tel: +356-21 37 64 36

DeutschlandNederland

UCB Pharma GmbH UCB Pharma B.V.

Tel: +49-(0) 2173 48 48 48 Tel.: +31-(0)76-573 11 40

EestiNorge

UCB Pharma Oy Finland UCB Nordic A/S

Tel: +358-92 514 4221 (Soome) Tlf: +45-32 46 24 00

Ελλ?δαÖsterreich

UCB Α.Ε. UCB Pharma GmbH

Τηλ: +30-2109974000 Tel: +43-(0)1 291 80 00

EspañaPolska

UCB Pharma S.A. UCB Pharma Sp. z o.o.

Tel: +34-91 570 34 44 Tel.: +48-22 696 99 20

FrancePortugal

UCB Pharma S.A. BIAL-Portela & Cª, S.A.

Tél: +33-(0)1 47 29 44 35 Tel: +351-22 986 61 00

HrvatskaRomânia

Medis Adria d.o.o. UCB Pharma România S.R.L.

Tel: +385-(0)1 230 34 46 Tel: +40-21 300 29 04

IrelandSlovenija

UCB (Pharma) Ireland Ltd. Medis, d.o.o.

Tel: +353-(0)1-46 37 395 Tel: +386-1 589 69 00

ÍslandSlovenská republika

Vistor hf. UCB s.r.o., organizačná zložka

Sími: +354-535 7000 Tel: +421-(0)-2 5920 2020

ItaliaSuomi/Finland

UCB Pharma S.p.A. UCB Pharma Oy Finland

Tel: +39-02 300 791 Puh/Tel: +358-92 514 4221

Κ?προςSverige

Lifepharma (Z.A.M.) Ltd UCB Nordic A/S

Τηλ: +357-22 05 63 00 Tel: +46-(0) 40 29 49 00

LatvijaUnited Kingdom

UCB Pharma Oy Finland UCB Pharma Ltd.

Tel: +358-92 514 4221 (Somija) Tel: +44-(0)1753 534 655

Date of Last Revision of this Package Insert:

Other Sources of Information

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