Neupro 8 mg/24 h transdermal patch
Spain
Table of Contents
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 the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Neupro is and what it is used for
- What you need to know before using Neupro
- How to use Neupro
- Possible adverse reactions
- How to store Neupro
- 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:
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you are allergic to rotigotine or to any of the other ingredients of this medicine (listed in section 6)
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you are scheduled for a magnetic resonance imaging (MRI) scan (diagnostic imaging of the inside of the body using magnetic energy instead of X-ray energy)
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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 after 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:
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you should have your blood pressure monitored regularly while using Neupro, especially at the beginning of treatment. Neupro may affect your blood pressure.
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you should have your vision checked regularly while using Neupro. If you notice any vision problems between check-ups, inform your doctor immediately.
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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.
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you may experience skin reactions caused by the patch – see ‘Skin problems caused by the patch’ in section 4.
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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 bending 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 experience loss of 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 thoughts
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 patient information leaflet.
This includes:
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an urge or overwhelming need to behave in an unusual way that you cannot control, which may harm you or others
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abnormal thoughts or behaviors.
For more information, see ‘Changes in behavior and abnormal thoughts’ in section 4.
Children and adolescents
This medicine must not be given to children under 18 years of age, as its safety and effectiveness have not been established in this age group.
Using Neupro with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes over-the-counter medicines and herbal preparations.
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:
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sedative medicines such as benzodiazepines, or medicines used to treat mental disorders or depression
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medicines that lower blood pressure. Neupro may lower blood pressure upon standing – this effect could be worsened by 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 can drink alcohol while using Neupro.
Pregnancy and breastfeeding
Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the fetus are unknown.
Do not breastfeed during treatment with Neupro. Rotigotine may pass into breast milk and affect your baby. It may also reduce the amount of breast milk produced.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 operate tools or machinery if you feel very sleepy – or engage in any activity where you or others may be at risk of serious injury.
Neupro contains sodium metabisulfite (E223)
Neupro contains sodium metabisulfite (E223), a substance that may rarely cause severe allergic (hypersensitivity) reactions and bronchospasm (difficulty breathing due to narrowing of the airways).
3. How to use Neupro
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. 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 reach the dose prescribed by your doctor.
- For doses above 8 mg/24 h (doses prescribed by your doctor exceeding the available strengths), multiple patches should be used to achieve the final 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, 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 reached 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, 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 reached 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 each 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.
Where to place the patch Apply the adhesive side of the patch to clean, dry, and intact skin in the following areas, as indicated by the gray areas in the drawing:
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To avoid skin irritation
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If you continue to experience skin problems caused by the patch, see "Skin reactions caused by the patch" in section 4 for more information.
To prevent the patch from loosening or coming off
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Do not apply the patch to an area where tight clothing may cause rubbing.
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Do not use creams, oils, lotions, powders, or any other skin products on the area where you will place the patch, nor on or near another patch you are already using.
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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.
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If the edges of the patch start to lift, you may secure the patch with adhesive tape.
If the patch falls off, you must apply a new one for the remainder of the day, and the next 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 hot, 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
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Each patch is individually packaged in a pouch.
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Before opening the pouch, decide where you will place the new patch and make sure you have removed the used patch.
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After opening the pouch and removing the protective liner from the patch, you should apply the patch to the skin immediately.
1 . To open the pouch, hold both sides of the pouch with both hands. |
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2. Peel apart the layers. |
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3. Open the pouch. |
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4. Remove the patch from the pouch. |
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5. The adhesive side of the patch is covered by a transparent disposable layer.
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9. Fold back the other half of the patch and remove the remaining part of the disposable cover. |
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This ensures the patch is in contact with the skin and the edges are well adhered. |
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11. Wash your hands immediately with soap and water after handling the patch. |
How to remove the used patch
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Gently and carefully remove the used patch.
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Gently wash the area with lukewarm water and a mild soap. This will remove any adhesive residue left on the skin. You may also use a small amount of baby oil to remove any remaining adhesive residue.
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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
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If you have forgotten to change the patch at your usual time, change it as soon as you remember. Remove the used patch and apply a new one.
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If you have forgotten 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 next 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 could cause a condition called 'neuroleptic malignant syndrome', which may 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 gets 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 short-lived. You should consult your doctor if these effects last a long time or if you are concerned.
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 more than a few days, if it is severe, or if it spreads beyond the area covered by the patch.
- Avoid exposure to sunlight and sunlamps 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 area 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, thought, 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 a strong urge or craving to behave in an unusual way and an inability to control the impulse, attack, or temptation to carry out certain actions that could harm you or others.
These actions may include:
- strong gambling addiction – even seriously affecting you or your family
- altered or increased sex drive and behaviour causing significant concern to you and others – for example, increased desire for sex
- uncontrolled shopping or excessive spending
- binge eating (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 changes in your behaviour, thought, or both, as 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, 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
- dizziness (spinning sensation)
- seeing or hearing things that are not real (hallucinations)
- low blood pressure upon standing, high blood pressure
- difficulty falling asleep, sleep disturbances, difficulty sleeping, nightmares, strange dreams
- involuntary movements related to Parkinson’s disease (dyskinesia)
- loss of consciousness, feeling dizzy upon standing due to a drop in blood pressure
- inability to control the impulse to carry out a harmful action including gambling addiction, meaningless repetitive actions, compulsive shopping, or excessive spending
- binge eating (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 sex drive
- 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 of irritability
- aggressive behaviour
- psychotic disorders
- widespread skin rash
- involuntary muscle spasms (seizures)
Not known: frequency cannot be estimated from the available data
- urge to take high doses of medicines such as Neupro – more than required for treating the disease. This is known as ‘dopaminergic 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed 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
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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.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that 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:
- Poly(dimethylsiloxane, trimethylsilyl silicate) copolymerized, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304), and DL-α-tocopherol (E307).
- Backing layer: Colored, aluminized, silicone-coated polyester film, with a pigment layer (titanium dioxide (E171), yellow pigment 13, red pigment 166, yellow pigment 12) and printed (red pigment 146, yellow pigment 180, black pigment 7).
- Disposable protective liner: Transparent fluoropolymer-coated polyester film.
Nature of the product and pack contents
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 is individually contained in a sachet.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels
Belgium
Manufacturer
UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine l’Alleud
Belgium
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 Tél/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 | Slovak Republic UCB s.r.o., organizačná zložka Tel: +421-(0)2 5920 2020 |
Italy UCB Pharma S.p.A. Tel: +39-02 300 791 | Finland/Finland 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 medicine is available on the European Medicines Agency website: https://www.ema.europa.eu