Rotigotine: package leaflet

For patients

Package leaflet, verbatim

Package leaflet: Neupro 1 mg/24 h transdermal patch / Neupro 3 mg/24 h transdermal patch

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.

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.

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 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 should be lowered gradually:
- Restless Legs Syndrome – lowered by 1 mg every other day.

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

- 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 in 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 Restless Legs Syndrome
Tell your doctor or pharmacist if you get any of the following side effects:

Very common: may affect more than 1 in 10 people
- headache

- feeling sick (nausea)

- feeling weak (fatigue)

- skin irritations under the patch such as redness and itching

Common: may affect up to 1 in 10 people
- itching

- feeling irritable

- allergic reaction

- increased sex drive

- high blood pressure

- vomiting, heartburn

- swelling of legs and feet

- feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams

- 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) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)

Uncommon: may affect up to 1 in 100 people
- feeling agitated

- feeling dizzy when standing up because of a fall in blood pressure

Rare: may affect up to 1 in 1,000 people
- being aggressive

- disorientation

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

- seeing or hearing things that are not real (hallucinations)

- nightmares

- paranoia

- confusion

- psychotic disorders

- delusion

- delirium

- feeling dizzy

- loss of consciousness, involuntary movements (dyskinesia)

- involuntary muscle spasms (convulsion)

  • blurry vision
  • visual disturbances such as seeing colours or lights
  • vertigo (sensation of whirling motion)
  • feeling of heartbeat (palpitation)
  • abnormal heart rhythm
  • low blood pressure
  • hiccups
  • constipation, dry mouth
  • stomach discomfort and pain
  • diarrhoea
  • redness, increased sweating
  • generalised itching, skin irritation
  • generalised rash
  • unable to achieve or maintain an erection
  • weight loss, weight increase
  • increased or abnormal liver function test results
  • increased heart rate
  • increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscles)
  • falling
  • rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems)

Talk to your doctor or pharmacist if you notice any of the side effects listed above.

Reporting of side effects
If you get any side effects, talk to your doctor or 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.

- 1 mg/24 h:

Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm2 contains 2.25 mg of rotigotine.

- 3 mg/24 h:
Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm2 contains 6.75 mg of rotigotine.

The other ingredients are:
- Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (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 yellow 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 1 mg/24 h or 3 mg/24 h.

Neupro is available in the following pack-sizes:
Cartons containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.

Not all pack sizes may be marketed.

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 9 2514 4231 (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 (Belgique/Belgien)

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 9 2514 4231 (Soome)

Norge
UCB Nordic A/S

Tlf: +47 / 67 16 5880

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. / 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

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 056300

Sverige
UCB Nordic A/S

Tel: +46-(0)40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (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: Neupro 2 mg/24 h transdermal patch

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.

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.

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 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 should be lowered gradually:
- Parkinson’s disease – lowered by 2 mg every other day.

- Restless Legs Syndrome – lowered by 1 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, 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.

- 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 in 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 – the symptoms are mainly seen in patients with Parkinson’s disease.

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

- 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.

Side effects when using Neupro for Restless Legs Syndrome
Tell your doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people
- headache

- feeling sick (nausea)

- feeling weak (fatigue)

- skin irritations under the patch such as redness and itching

Common: may affect up to 1 in 10 people
- itching

- feeling irritable

- allergic reaction

- increased sex drive

- high blood pressure

- vomiting, heartburn

- swelling of legs and feet

- feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams

- 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) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)

Uncommon: may affect up to 1 in 100 people
- feeling agitated

- feeling dizzy when standing up because of a fall in blood pressure

Rare: may affect up to 1 in 1,000 people
- being aggressive

- disorientation

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

- seeing or hearing things that are not real (hallucinations)

- nightmares

- paranoia

- confusion

- psychotic disorders

- delusion

- delirium

- feeling dizzy

- loss of consciousness, involuntary movements (dyskinesia)

- involuntary muscle spasms (convulsion)

  • blurry vision
  • visual disturbances such as seeing colours or lights
  • vertigo (sensation of whirling motion)
  • feeling of heartbeat (palpitation)
  • abnormal heart rhythm
  • low blood pressure
  • hiccups
  • constipation, dry mouth
  • stomach discomfort and pain
  • diarrhoea
  • redness, increased sweating
  • generalised itching, skin irritation
  • generalised rash
  • unable to achieve or maintain an erection
  • weight loss, weight increase
  • increased or abnormal liver function test results
  • increased heart rate
  • increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscles)
  • falling
  • rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems)

Talk to your doctor or pharmacist if you notice any of the side effects listed above.

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.

- Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm2 contains 4.5 mg of rotigotine.

The other ingredients are:
- Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (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 yellow 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.

Neupro is available in the following pack-sizes:
Cartons containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.

Not all pack sizes may be marketed.

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 9 2514 4231 (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 (Belgique/Belgien)

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 9 2514 4231 (Soome)

Norge
UCB Nordic A/S

Tlf: +47 / 67 16 5880

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. / 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

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 056300

Sverige
UCB Nordic A/S

Tel: +46-(0)40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (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: Neupro 4 mg/24 h transdermal patch / Neupro 6 mg/24 h transdermal patch / Neupro 8 mg/24 h transdermal patch

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.

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.

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 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 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.

- 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 in 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

- 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.

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.

- 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 palmitate (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 yellow 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 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.

Neupro is available in the following pack-sizes:
Cartons containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.

Not all pack sizes may be marketed.

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 9 2514 4231 (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 (Belgique/Belgien)

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 9 2514 4231 (Soome)

Norge
UCB Nordic A/S

Tlf: +47 / 67 16 5880

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. / 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

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 056300

Sverige
UCB Nordic A/S

Tel: +46-(0)40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (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: Neupro 2 mg/24 h / Neupro 4 mg/24 h / Neupro 6 mg/24 h / Neupro 8 mg/24 h / Transdermal patch

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.

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.

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.

  • 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 in 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

  • 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.

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 cm2 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 palmitate (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 yellow 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.

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 9 2514 4231 (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 (Belgique/Belgien)

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 9 2514 4231 (Soome)

Norge
UCB Nordic A/S

Tlf: + 47 / 67 16 5880

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. / 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

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 056300

Sverige
UCB Nordic A/S

Tel: +46-(0)40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (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.

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.