InfoCons Consumer Protection informs you – Neupro – Package Leaflet

Before anything else

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.

ℹ️ 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 called ‘dopamine agonists’. Dopamine is a messenger in the brain which is important 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 on its own or with another medicine called levodopa.

⚠️ 2. What you need to know before you use Neupro

Do not use Neupro if

• you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
• you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
• you need ‘ cardioversion ’ (specific treatment for abnormal heart beat).

You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on afterwards.

162 If any of the above apply to you, do not use Neupro. If you are not sure about this, talk to your doctor or pharmacist or nurse first.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Neupro. This is because

• your blood pressure needs checking regularly while using Neupro, especially at the start of the treatment. Neupro may affect your blood pressure.
• your eyes need checking regularly while using Neupro. If you notice any problems with your eyesight between checks, talk to your doctor straight away.
• if you have serious liver problems , your doctor may need to change the dose. If your liver problems get worse during treatment, talk to your doctor straight away.
• you may get skin problems 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 using machines ’ in section 2.
• you may get involuntary muscle contractions causing abnormal, often repetitive movements or postures (dystonia), posture abnormal or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to adjust your medication.

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

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

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

Changes in behaviour and abnormal thinking Neupro can cause side effects that change your behaviour (how you act). You may find it helpful to tell a member of your family or carer that you are using this medicine and ask them to read this leaflet.

This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.

These include:

• craving for large doses of Neupro or other medicines used to treat Parkinson’s disease.
• unusual urges or cravings which you cannot resist and that could harm yourself or others
• abnormal thinking or behaviour.

See ‘ Changes to your behaviour and abnormal thinking ’ in section 4 for more information.

Children and adolescents

Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.

Other medicines and Neupro

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

If you are treated with Neupro and levodopa at the same time, some side effects may get more serious.

This includes seeing or hearing things that are not real (hallucinations), movements you cannot control related to Parkinson’s disease (‘dyskinesia’), and swelling of legs and feet.

163 Do not take the following medicines while using Neupro – because they may decrease its effect:

• ‘anti-psychotic’ medicines – used to treat certain mental illnesses
• metoclopramide – used to treat nausea (feeling sick) and vomiting.

Talk to your doctor before using Neupro if you are taking:

• sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression .
• medicines that lower blood pressure. Neupro may decrease blood pressure when you stand up – this effect may be worsened by the medicines used to lower blood pressure.

Your doctor will let you know if it is safe to keep taking these medicines while using Neupro.

Neupro with food, drink and alcohol

Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to drink alcohol while using Neupro.

Pregnancy and breast -feeding Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are not known.

Do not breast -feed during treatment with Neupro. This is because rotigotine may pass into your breast milk and affect your baby. It is also likely to lower the amount of milk you produce.

If you are pregnant or breast -feeding, 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 may make you feel very sleepy and you may fall asleep very suddenly. If this happens, do not drive. In isolated cases people have fallen asleep while driving and this has caused accidents.

Also do not use tools or machines if you feel very sleepy – or do anything else which may put others or yourself at risk of serious injury.

Neupro contains sodium metabisulphite (E223)

Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).

💊 3. How to use Neupro

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Which strength patches to use The dose of Neupro will depend on your illness – see below.

Neupro is available in different strength patches which release the medicine over 24 hours. The strengths 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 have to use more than one patch to reach your dose, as prescribed by your doctor.

The Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches in each package. These packages are usually needed for the first four weeks of therapy, but depending on your response to Neupro, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.

164 On the first day of treatment, start with Neupro 2 mg (package marked “Week 1”), and use one Neupro 2 mg transdermal patch daily. You should take Neupro 2 mg for 7 days (e.g. if you start on a Sunday, switch to the next dose on the following Sunday).

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

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

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

The right dose for you will depend on your needs.

4 mg of Neupro every day may be an effective dose for some patients. For most patients with early stage Parkinson’s disease, the right dose is reached within 3 or 4 weeks, at doses of 6 mg per day or 8 mg per day, respectively. The maximum dose is 8 mg per day. For most patients with advanced – stage Parkinson’s disease the right dose is reached within 3 to 7 weeks, at 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 strengths), multiple patches must be applied to achieve the final dose. For example, a daily dose of 14 mg can be reached by applying one patch of 6 mg/24 h and one patch of 8 mg/24 h and likewise, a daily dose of 16 mg can be reached by applying two patches of 8 mg/24 h.

If you have to stop taking this medicine see ‘If you stop using Neupro’ in section 3.

How to use the Neupro patches Neupro is a patch that is put on the skin.

• Make sure that you take the old patch off before putting on a new one.
• Stick the new patch on a different area of the skin each day .
• Leave the patch on your skin for 24 hours, then take it off and put on a new one.
• Change the patch at about the same time every day .
• Do not cut the Neupro patches into pieces.

Where to stick the patch Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:

• Shoulder or upper arm.
• Belly.
• Flank (your side, between the ribs and hips).
• Thigh or hip.

To avoid skin irritation

• Stick the patch onto a different area of skin each day . For example, put it on the right side of your body one day, then on the left side of your body the next day. Or on your upper body one day, then on your lower body the day after that.
• Do not stick Neupro on the same area of skin twice within 14 days .
• Do not stick the patch on broken or damaged skin – or on skin that is red or irritated .

If you still get problems with your skin because of the patch, please see ‘Skin problems caused by the patch’ in section 4 for more information.

To prevent the patch becoming loose or falling off

• Do not put the patch in an area where it can be rubbed by tight clothing .
• Do not use creams, oils, lotions, powders or other skin products where you will put the patch.

Also do not use them on or near a patch you are already wearing.

165 • If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days before sticking the patch there.

• If the edges of the patch lift, the patch may be taped down with adhesive medical tape.

If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual time.

• Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, heating pads or hot -water bottles. This is because the medicine may be released faster. If you think that too much heat has been applied, 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, keep that area protected from direct sunlight . This is because it may change the colour of the skin.

How to use the patch

• Each patch is packed in a separate sachet.
• Before opening the sachet decide where you are going to stick this new patch and check you have removed any old patch.
• Stick the Neupro patch onto your skin as soon as you have opened the sachet and removed the release liner.

1.

To open the sachet, hold the sachet in both hands.

2.

Peel apart the foil.

3.

Open the sachet.

4.

Take the patch out of the sachet.

166 5.

The sticky side of the patch is covered by a transparent release liner.

• Hold the patch in both hands with the release liner facing you.

6.

• Bend the patch in half.

This makes the S -shaped break in the liner open up.

7.

• Peel off one side of the release liner.
• Do not touch the sticky side of the patch with your fingers.

8.

• Hold the other half of the rigid release liner.
• Then put the sticky half of the patch onto your skin.
• Press the sticky side of the patch firmly into place.

9.

Fold back the other half of the patch and remove the other side of the release liner.

10.

• Press the patch down firmly with the palm of your hand.
• Keep it pressed for about 30 seconds.

This makes sure the patch is touching the skin and the edges stick down well.

11.

Wash your hands with soap and water straight after handling the patch.

167 How to take off a used patch

• Slowly and carefully peel off the used patch.
• Gently wash the area with warm water and mild soap. This will remove any stickiness that stays on your skin. You can also use a little baby oil to remove any stickiness that will not wash off.
• Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate your skin.

If you use more Neupro than you should

Using higher doses of Neupro than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions. In such cases, contact your doctor or hospital straight away. They will tell you what to do.

If you have used a different patch (e.g. Neupro 4 mg/24 h instead of Neupro 2 mg/24 h) than your doctor told you to, contact your doctor or hospital for advice immediately, and follow their advice on changes of patches.

If you have any unpleasant reactions, contact your doctor.

If you forget to change the patch at your usual time

• If you have forgotten to change the patch at your usual time, change it as soon as you remember. Take off the old patch and use a new one.
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.

In both cases, use a new patch at the usual time on the following day. Do not use a double dose to make up for a forgotten dose.

If you stop using Neupro

Do not stop using Neupro without talking to your doctor. A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome’ which could be life -threatening. The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).

If your doctor says you should stop Neupro, the daily dose of Neupro should be lowered gradually:

• Parkinson’s disease – lowered by 2 mg every other day.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist or nurse if you notice any side effects.

Side effects more likely at the start of treatment You may feel sick (nausea) and vomit at the start of treatment . These effects are usually mild or moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are worried about them.

Skin problems caused by the patch

• You may get redness and itching on the skin where the patch has been – these reactions are usually mild or moderate.
• The reactions normally go away after a few hours – once you remove the patch.
• Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe.

Also do this if it spreads outside the area of skin that was covered by the patch.

168 • Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.

• To help avoid the skin reactions, you should put the patch on a different area of skin every day, and only use the same area again after 14 days.

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

Changes i n behaviour and abnormal thinking Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below.

They will discuss ways of managing or reducing symptoms.

You may find it helpful to also tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour. Neupro can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.

These may include:

• strong impulse to gamble too much – even if this seriously affects you or your family
• altered or increased sexual interest and behaviour which causes significant concern to you or others – for example, an increased sex drive
• uncontrolled shopping or spending too much
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Neupro may cause other behaviours and abnormal thinking. These may include:

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

Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above.

They will discuss ways of managing or reducing symptoms.

Allergic reactions Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, tongue or lips.

Side effects when using Neupro for Parkinson’s disease Tell your doctor, pharmacist or nurse if you get any of the following side effects:

Very common : may affect more than 1 in 10 people

• headache
• feeling sleepy or dizzy
• feeling sick (nausea), vomiting
• skin reactions under the patch such as redness and itching

Common : may affect up to 1 in 10 people

• falling
• hiccups
• weight loss 169 • swelling of legs and feet
• feeling weak (fatigue), feeling tired
• feeling of heartbeat (palpitation)
• constipation, dry mouth, heartburn
• redness, increased sweating, itching
• vertigo (sensation of whirling motion)
• seeing or hearing things that are not real (hallucinations)
• low blood pressure when standing up, high blood pressure
• difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams
• movements you cannot control related to Parkinson’s disease (dyskinesia)
• fainting, feeling dizzy when standing up because of fall in blood pressure
• unable to resist the impulse to perform an action that is harmful involving excessive gambling, repetitive meaningless actions, uncontrolled shopping or spending too much
• binge eating (eating large amount of food in a short period of time), compulsive eating (eating more food than normal and more than needed to satisfy hunger)

Uncommon : may affect up to 1 in 100 people

• blurred vision
• weight increase
• allergic reaction
• low blood pressure
• increased heart rate
• increased sex drive
• abnormal heart beat
• stomach discomfort and pain
• generalised itching, skin irritation
• falling asleep suddenly without warning
• unable to achieve or maintain an erection
• feeling agitated, disorientated, confused or paranoid
• increased or abnormal liver test results
• sight problems 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 people

• delusion
• delirium
• feeling irritable
• being aggressive
• psychotic disorders
• rash over larger parts of the body
• involuntary muscle spasms (convulsion)

Not known : it is not known how often these happen

• craving large doses of medicines like Neupro – more than needed for the illness. This is known as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro.
• diarrhoea
• dropped head syndrome
• rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems) Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

170 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Neupro

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

Do not use this medicine after the expiry date which is stated on the label and carton.

Do not store above 30°C.

What to do with the used and unused patches

• Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then throw it away safely, out of the reach of children
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Neupro contains

The active substance is rotigotine.

• 2 mg/24 h:

Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm 2 contains 4.5 mg of rotigotine.

• 4 mg/24 h:

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

• 6 mg/24 h:

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

• 8 mg/24 h:

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

The other ingredients are:

• Poly(dimethylsiloxane, trimethylsilyl silicate) -copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palm itate (E304) and DL-α -tocopherol (E307).
• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide ( E171) , pigment yellow 13, pigment red 166, pigment yellow 12) layer and imprinted (pigment red 146, pigment yel low 180, pigment black 7).
• Release liner: Transparent fluoropolymer coated polyester film.

What Neupro looks like and contents of the pack

Neupro is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges.

The outside is tan -coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.

171 Neupro is available in the following pack-sizes:

One treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, which are individually sealed in sachets.

Marketing Authorisation Holder

UCB Pharma S.A.

Allée de la Recherche 60 B-1070 Bruxelles Belgium

Manufacturer

UCB Pharma S.A.

Chemin du Foriest B-1420 Braine l’Alleud Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien UCB Pharma SA/NV Tél/Tel: +32 -(0)2 559 92 00 Lietuva UCB Pharma Oy Finland Tel: +358 -92 514 4221 (Suomija) България Ю СИ БИ България ЕООД Teл.: +359-(0)2 962 30 49 Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: +32 -(0)2 559 92 00 Česká republika UCB s.r.o.

Tel: +420 -221 773 411 Magyarország UCB Magyarország Kft.

Tel.: +36 -(1) 391 0060 Danmark UCB Nordic A/ S Tlf.: +45 -32 46 24 00 Malta Pharmasud Ltd.

Tel: +356 -21 37 64 36 Deutschland UCB Pharma GmbH Tel: +49 -(0) 2173 48 48 48 Nederland UCB Pharma B.V.

Tel: +31 -(0)76 -573 11 40 Eesti UCB Pharma Oy Finland Tel: +358 -92 514 4221 (Soome) Norge UCB Nordic A/S Tlf: +45 -32 46 24 00 Ελλάδα UCB Α.Ε.

Τηλ: +30 -2109974000 Österreich UCB Pharma GmbH Tel: +43 -(0)1 291 80 00 España UCB Pharma S.A.

Tel: +34 -91 570 34 44 Polska UCB Pharma Sp. z o.o.

Tel.: +48 -22 696 99 20 172 France UCB Pharma S.A.

Tél: +33 -(0)1 47 29 44 35 Portugal BIAL -Portela & Cª, S.A.

Tel: +351-22 986 61 00 Hrvatska Medis Adria d.o.o.

Tel: +385 -(0)1 230 34 46 România UCB Pharma România S.R.L.

Tel: +40 -21 300 29 04 Ireland UCB (Pharma) Ireland Ltd.

Tel: +353 -(0)1 46 37 395 Slovenija Medis, d.o.o.

Tel: +386 -1 589 69 00 Ísland UCB Nordic A/S Sími: + 45 / 32 46 24 00 Slovenská republika UCB s.r.o. , organizačná zložka Tel: +421 -(0)2 5920 2020 Italia UCB Pharma S.p.A.

Tel: +39 -02 300 791 Suomi/Finland UCB Pharma Oy Finland Puh/Tel: +358 -92 514 4221 Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: +357 -22 05 63 00 Sverige UCB Nordic A/S Tel: +46 -(0)40 29 49 00 Latvija UCB Pharma Oy Finland Tel: +358 -92 514 4221 (Somija)

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Neupro (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/05/331).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.