Neupro 6 mg/24 h transdermal patch

Package leaflet: Information for the user

Introduction

Package leaflet: 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 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Neupro is and what it is used for

What Neupro is

Neupro contains the active substance rotigotine.

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

What Neupro is used for

Neupro is used in adults to treat the signs and symptoms of:

• Parkinson's disease - Neupro may be used alone or together with another medicine called levodopa.

2. What you need to know before using Neupro

Do not use Neupro if:

• you are allergic to rotigotine or to any of the other ingredients of this medicine (listed in section 6)
• you are scheduled to undergo a magnetic resonance imaging (MRI) scan (diagnostic images of the inside of the body created using magnetic energy instead of X-ray energy)
• you require cardioversion (a specific treatment for heart rhythm disorders).

You must remove the Neupro patch immediately before undergoing an MRI scan or cardioversion to avoid skin burns, as the patch contains aluminum. You may apply a new patch once these procedures are completed.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Neupro, because:

• you should have your blood pressure monitored regularly while using Neupro, especially at the beginning of treatment. Neupro may affect your blood pressure.
• you should have regular eye examinations while using Neupro. If you notice any vision problems between examinations, inform your doctor immediately.
• if you have severe liver problems, your doctor may need to adjust your dose. If your liver problems worsen during treatment with Neupro, inform your doctor as soon as possible.
• you may experience skin reactions caused 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 use of machines’ in section 2.

You may experience involuntary muscle contractions causing abnormal movements or postures, often repetitive (dystonia), abnormal postures, or lateral flexion of the spine (also known as pleurosthotonos or Pisa syndrome). If this occurs, 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 is especially likely when starting Neupro treatment or when the dose is increased. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thinking

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

This includes:

• an urge or overwhelming need to behave in an unusual way that you cannot control, which may harm you or others
• abnormal thoughts or behaviors.

For further information, see ‘Changes in behavior and abnormal thinking’ in section 4.

Children and adolescents

This medicine must not be given to children under 18 years of age, as its safety and effectiveness in this age group are unknown.

Using Neupro with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 worsen. These include seeing or hearing things that are not real (hallucinations), uncontrolled movements related to Parkinson’s disease (dyskinesia), and 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 upon standing – this effect may be worsened when taking blood pressure-lowering medicines.

Your doctor will advise you whether 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, eating or drinking does not affect how this medicine is absorbed. You should consult your doctor about whether you may drink alcohol while using Neupro.

Pregnancy and breastfeeding

Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are unknown.

Do not breastfeed during treatment with Neupro. This is because rotigotine may pass into breast milk and harm your baby. It may also 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 use of machines

Neupro may make you feel very sleepy and may cause you to fall asleep suddenly. If this happens, do not drive. In isolated cases, some people have fallen asleep while driving, leading to accidents.

Do not use tools or machinery if you feel very sleepy – or engage in any activity where you or others could be at risk of serious injury.

Neupro contains sodium metabisulfite (E223)

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

3. How to use Neupro

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If in doubt, consult your doctor or pharmacist.

Which patch dose 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 dose prescribed by your doctor.

• For doses above 8 mg/24 h (doses prescribed by your doctor that exceed the available patch strengths), multiple patches must be used to reach the total daily dose. For example, a daily dose of 10 mg can be achieved by using one 6 mg/24 h patch and one 4 mg/24 h patch.

• The patches must not be cut into pieces.

Treatment of Parkinson's Disease

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

• Your starting dose will be one 2 mg/24 h patch per day.

• From the second week onwards, 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 within 3 to 4 weeks.

• The maximum dose is 8 mg per day.

Patients taking levodopa – advanced stages of Parkinson's disease

• Your starting dose will be one 4 mg/24 h patch per day.

• From the second week onwards, 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 within 3 to 7 weeks.

• The maximum dose is 16 mg per day.

If you need to stop taking this medicine, see "If you stop using Neupro" in section 3.

How to use Neupro patches

Neupro is a patch applied to the skin.

• Make sure you have removed the 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 patch at approximately the same time each day.
• Do not cut Neupro patches into pieces.

If you need to stop taking this medicine, see "If you stop using Neupro" in section 3.

How to use Neupro patches

Neupro is a patch applied to the skin.

• Make sure you have removed the used patch before applying a new one.
• Apply the 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 patch at approximately the same time each day.
• Do not cut Neupro patches into pieces.

Where to place the patch Apply the adhesive side of the patch to clean, dry skin in the following areas, as indicated by the gray areas in the drawing: Shoulder or upper arm. Abdomen. Sides (flanks, between the ribs and hips). Thigh or hip.

To avoid skin irritation Apply the patch to a different area of skin each day. For example, on the right side of the body one day, and the next day on the left side. Or on the upper part of the body one day, and the lower part the next day. Do not apply the Neupro patch to the same area of skin until 14 days have passed since it was last applied to that site. Do not apply the patch to an area of damaged skin or one with a wound – or over red or irritated skin.

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

To prevent the patch from loosening or detaching

• Do not apply the patch to an area where tight clothing may cause friction.

• Do not use creams, oils, lotions, powders, or any other skin products where you are going to place the patch, nor on top of or near another patch you are already using.

• If you need to apply a patch to a hairy area of skin, you should shave (remove hair from) the area at least 3 days before applying the patch.

• If the edges of the patch start to lift, you may secure the patch with medical tape.

If the patch falls off, you must apply a new one for the remainder of the day, and on the following day, apply a new patch at your usual time.

• You should avoid exposing the patch area to heat – for example, excessive sunlight, saunas, hot baths, or hot water bottles. This is because the medicine could be released too quickly. If you think the patch has become too warm, 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 protect the irritated area from direct sunlight. This is because sun exposure could cause changes in skin pigmentation.

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 make sure you have removed the used patch.

• After opening the pouch and removing the protective liner from the patch, you should immediately apply the patch to your skin.

1 . To open the pouch, hold both sides of the pouch with both hands.
2. Peel apart the layers.
3. Open the pouch.
4. Remove the patch from the pouch.
5. The adhesive side of the patch is covered by a transparent disposable liner. Hold the patch with both hands, with the disposable liner facing you.
6. Fold the patch in half until the S-line on the disposable liner opens.
7. Remove the disposable liner from one side. Do not touch the adhesive surface of the patch with your fingers.
8. Hold the other half of the rigid disposable liner. Apply the adhesive surface of the patch to the skin. Firmly press the adhesive surface of the patch.
9. Fold back the other half of the patch and remove the remaining part of the disposable liner.
10. Firmly press the patch with the palm of your hand. Hold pressure on the patch for about 30 seconds. This ensures that the patch is in contact with the skin and the edges are well adhered.
11. Wash your hands immediately with water and soap after handling the patch.

How to remove the used patch

• Gently and carefully remove the used patch.
• Wash the area gently with lukewarm water and mild soap to remove any adhesive residue remaining on the skin. You may also use a small amount of baby oil to remove any remaining adhesive.
• Do not use alcohol or other liquid solvents—such as nail polish remover—as these could irritate your skin.

If you use more Neupro than you should

Using higher doses of Neupro than your doctor has prescribed may cause adverse 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.

In such cases, inform your doctor or go to the hospital as soon as possible. They will advise you on what to do.

If you forget to change the patch at your usual time

• If you forget to change the patch at your usual time, do so as soon as you remember. Remove the used patch and apply a new one.
• If you forget to apply a new patch after removing the used one, apply the new patch as soon as you remember.

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

If you stop using Neupro

Do not stop using Neupro without first consulting your doctor. Suddenly stopping treatment may cause a condition called 'neuroleptic malignant syndrome,' which can be life-threatening. Signs include: loss of muscle movement (akinesia), muscle rigidity, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, and reduced level of consciousness (e.g., coma).

If your doctor advises you to stop treatment with Neupro, the daily dose of Neupro should be gradually reduced:

• Parkinson’s disease – reduce by 2 mg every two days.

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

4. Possible adverse effects

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

Most likely adverse effects at the beginning of treatment

You may experience nausea and vomiting at the beginning of treatment. These effects are usually mild or moderate and last for a short time. You should consult your doctor if these effects last a long time or if you are concerned about them.

Skin problems caused by the patch

• Redness and itching may occur at the site of skin where the patch has been applied – these reactions are usually mild or moderate.

• These reactions usually disappear within a few hours after removing the patch.

• Consult your doctor if you have a skin reaction lasting longer than a few days, if it is severe, or if it spreads beyond the area covered by the patch.

• Avoid exposure to sunlight and sunbeds on areas of skin showing 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 site again after 14 days.

You may experience loss of consciousness

Neupro may cause loss of consciousness. This may occur especially when starting treatment with Neupro or when the dose is increased. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behaviour and abnormal thoughts

Inform your doctor if you notice any changes in behaviour, thinking, or both, as listed below.

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

If your family, caregiver, or doctor are concerned about changes in your behaviour, it may be helpful to inform a family member or caregiver that you are using this medicine and to have them read the leaflet. Neupro may cause urges or strong desires to behave in unusual ways and an inability to control the impulse, attack, or temptation to carry out certain actions that may harm you or others.

These actions may include:

• strong gambling addiction – even if it seriously affects you or your family
• altered or increased sexual interest and behaviour causing significant concern to you and others – for example, increased libido
• uncontrolled shopping or excessive spending
• binge eating episodes (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 may cause other abnormal behaviours and thoughts, which may include:

• abnormal thoughts about reality
• delusional ideas and hallucinations (seeing or hearing things that are not real)
• confusion
• disorientation
• aggressive behaviour
• agitation
• delirium.

Inform your doctor if you notice any of the changes in behaviour, thinking, or both, listed above.

Your doctor will advise you on 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.

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: may affect more than 1 in 10 patients

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

Common: may affect up to 1 in 10 patients

• falls
• hiccups
• weight loss
• swelling in the legs and feet
• feeling of weakness (fatigue), feeling tired
• increased heart rate (palpitations)
• constipation, dry mouth, heartburn
• redness, increased sweating, itching
• vertigo (spinning sensation)
• seeing or hearing things that are not real (hallucinations)
• low blood pressure when standing up, high blood pressure
• difficulty falling asleep, sleep disturbances, difficulty sleeping, nightmares, unusual dreams
• involuntary movements related to Parkinson’s disease (dyskinesia)
• loss of consciousness, dizziness upon standing caused by a drop in blood pressure
• inability to control the impulse to perform a harmful action, including gambling addiction, meaningless repetitive actions, compulsive shopping, or excessive spending
• binge eating episodes (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 libido
• abnormal heart rhythm
• stomach discomfort and pain
• generalized itching, skin irritation
• falling asleep suddenly without warning
• inability to achieve or maintain an erection
• feeling agitated, disoriented, confused, or paranoid
• abnormal or elevated liver function test results
• visual disturbances such as seeing colours or lights
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscles)

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

• delusional ideas
• delirium
• feeling irritable
• aggressive behaviour
• psychotic disorders
• widespread skin rash
• involuntary muscle spasms (seizures)

Not known: frequency cannot be estimated from the available data

• anxiety to take high doses of medicines such as Neupro – more than needed for the treatment of the disease. This is known as 'dopamine dysregulation syndrome' and may lead to excessive use of Neupro
• diarrhoea
• dropped head syndrome
• rhabdomyolysis (a rare, serious muscle disorder causing pain, tenderness, and weakness of muscles and may lead to kidney problems)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide 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 expiry date stated on the label and on the cardboard box.

Do not store above 30°C.

How to dispose of used and unused patches

• Used patches still contain the active substance, 'rotigotine', which may be harmful to others. Fold the used patch with the adhesive side inwards. Place the patch back into its original envelope and then dispose of it safely, out of the reach of children.

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

6. Contents of the pack and other information

Composition of Neupro

The active substance is rotigotine.

• 4 mg/24 h:

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

• 6 mg/24 h:

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

• 8 mg/24 h:

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

The other components are:

• Cross-linked poly(dimethylsiloxane, trimethylsilyl silicate) copolymer, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304), and DL-α-tocopherol (E307).
• Backing layer: Colored aluminized, siliconized polyester film, with a pigment layer (titanium dioxide (E171), pigment yellow 13, pigment red 166, pigment yellow 12) and printed (pigment red 146, pigment yellow 180, pigment black 7).
• Release liner: Transparent polyester film coated with fluoropolymer.

Release liner: Transparent polyester film coated with fluoropolymer.

Nature and contents of the container

Neupro is a transdermal patch. It is thin and consists of three layers. It is square-shaped with rounded corners. The outer surface is brownish in color and printed with the label Neupro 4 mg/24 h, Neupro 6 mg/24 h, or Neupro 8 mg/24 h.

Neupro is available in the following pack sizes:

Carton packs containing 7, 14, 28, 30 or 84 patches (multiple pack containing 3 packs of 28), each patch individually enclosed in a sachet.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

UCB Pharma S.A.

Allée de la Recherche 60

B-1070 Brussels

Belgium

Manufacturer

UCB Pharma S.A.

Chemin du Foriest

B-1420 Braine l’Alleud

Belgium

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

Belgium/Belgium/Belgium UCB Pharma SA/NV Tel/Tel: +32-(0)2 559 92 00	Lithuania UCB Pharma Oy Finland Tel: + 358 9 2514 4231 (Finland)
	Luxembourg/Luxembourg UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00 (Belgium/Belgium)
Czech Republic UCB s.r.o. Tel: +420-221 773 411	Hungary UCB Magyarország Kft. Tel.: +36-(1) 391 0060
Denmark UCB Nordic A/S Tlf.: +45-32 46 24 00	Malta Pharmasud Ltd. Tel: +356-21 37 64 36
Germany UCB Pharma GmbH Tel: +49-(0) 2173 48 48 48	Netherlands UCB Pharma B.V. Tel: +31-(0)76-573 11 40
Estonia UCB Pharma Oy Finland Tel: + 358 9 2514 4231 (Finland)	Norway UCB Nordic A/S Tlf: + 47 / 67 16 5880
Greece UCB Α.Ε. Tel: +30-2109974000	Austria UCB Pharma GmbH Tel: +43-(0)1 291 80 00
Spain UCB Pharma S.A. Tel: +34-91 570 34 44	Poland UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel: + 48 22 696 99 20
France UCB Pharma Tél: + 33 / (0)1 47 29 44 35	Portugal BIAL-Portela & Cª, S.A. Tel: +351-22 986 61 00
Croatia Medis Adria d.o.o. Tel: +385-(0)1 230 34 46	Romania UCB Pharma România S.R.L. Tel: +40-21 300 29 04
Ireland UCB (Pharma) Ireland Ltd. Tel: +353-(0)1-46 37 395	Slovenia Medis, d.o.o. Tel: +386-1 589 69 00
Iceland UCB Nordic A/S Sími: + 45 / 32 46 24 00	Slovakia UCB s.r.o., organizačná zložka Tel: +421-(0)2 5920 2020
Italy UCB Pharma S.p.A. Tel: +39-02 300 791	Finland/Sweden UCB Pharma Oy Finland Puh/Tel: +358-92 514 4221
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 056300	Sweden UCB Nordic A/S Tel: +46-(0)40 29 49 00
Latvia UCB Pharma Oy Finland Tel: + 358 9 2514 4231 (Finland)

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.euopa.eu