Neupro 3 mg/24 h parche transdermico

Prospect: information for the user

Neupro 1 mg/24 h transdermal patch

Neupro 3 mg/24 h transdermal patch

Rotigotine

Read this prospect carefully before starting to use the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

What is Neupro

Neupro contains the active ingredient rotigotine.

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

What is Neupro used for

Neupro is used in adults to treat the symptoms of:

• Restless Legs Syndrome(RLS)–this syndrome may be associated with discomfort in the legs or arms, need to move, sleep disturbances and feeling of fatigue or sleepiness during the day. Treatment with Neupro reduces or decreases the duration of these symptoms.

Do not use Neupro if:

• You areallergicto rotigotine or any of the othercomponentsof this medication (listed in section 6)

• You are going to have amagnetic resonance imaging(MRI) scan (diagnostic images of the inside of the body, created using magnetic energy instead of X-ray energy)

• You need acardioversion(specific treatment for heart rhythm disorders)

Remove the Neupro patch just before undergoing an MRI or cardioversion to avoid skin burns, as the patch contains aluminum. You can put a new patch on when these tests are finished.

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

Warnings and precautions

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

• You mustmonitor your blood pressureperiodically while using Neupro, especially at the beginning of treatment. Neupro may affect your blood pressure.

• You musthave your vision checkedperiodically while using Neupro. If you notice any vision problems between check-ups, inform your doctor immediately.

• If you havesevere liver problems, your doctor may need to adjust the dose. If your liver problems worsen during Neupro treatment, inform your doctor as soon as possible.

• You may experienceskin reactionscaused by the patch – see ‘Skin problems caused by the patch’ in section 4.

• You mayfeel very drowsy or fall asleep suddenly– see ‘Driving and operating machines’ in section 2.

• The symptoms ofRestless Legs Syndromemay start before treatment, be more intense, and involve other parts of the body. If you experience these symptoms before or after starting Neupro treatment, contact your doctor as your treatment may need to be adjusted.

You may lose consciousness

Neupro may cause loss of consciousness. This can occur especially 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 produce side effects that change your behavior (how you act). If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to inform a family member or caregiver that you are using this medication and have them read the leaflet.

For more information, see ‘Changes in behavior and abnormal thoughts’ in section 4.

Children and adolescents

This medicationshould not be administeredtochildrenunder 18 years of age, as its safety and efficacy in this age group are unknown.

Using Neupro with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal remedies.

Do not take the following medications while using Neupro, as they may reduce its effect:

• ‘antipsychotic’ medications – used to treat certain mental illnesses
• metoclopramide – used to treat nausea and vomiting

Consult your doctor before using Neupro if you are taking:

• sedatives such as benzodiazepines or medications used to treat mental disorders or depression

• blood pressure-lowering medications. Neupro may lower blood pressure when standing up – this effect may worsen when taking medications to lower blood pressure.

Your doctor will inform you if it is safe to take these medications while using Neupro.

Using Neupro with food, drinks, and alcohol

Since rotigotine enters the bloodstream through the skin, taking food or drinks does not affect how this medication is absorbed. Consult your doctor if you can drink alcohol while using Neupro.

Pregnancy and breastfeeding

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

Do not breastfeed during Neupro treatment. This is because rotigotine may pass into breast milk and affect your baby. It is also likely to reduce milk production.

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Neupro may make you feel very drowsy and may cause you to fall asleep suddenly. If this happens, do not drive.

In rare cases, some people have fallen asleep while driving, leading to accidents.

Do not use tools or machines if you feel very drowsy – or engage in any activity that may put you or others at risk of serious injury.

Neupro contains sodium metabisulfite (E223)

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

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

Which patch dose to use

Neupro is available in patches of different doses that release the medication over 24 hours. The doses are 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h for the treatment of Restless Legs Syndrome.

• Your starting dose of treatment will be a patch of 1 mg/24 h per day.

• From the second week, the daily dose will be increased by 1 mg weekly until the appropriate maintenance dose for you is reached. This is when you and your doctor confirm that your symptoms are adequately controlled and that the medication's side effects are acceptable.

• Follow the instructions indicated by your doctor carefully.
• The maximum dose is 3 mg per day.

If you have to stop taking this medication, see “Stopping treatment with Neupro”in section 3.

How to use Neupro patches

Neupro is a patch that is applied to the skin.

• Check that the used patch has been removed before putting on a new one.
• Put the new patch on adifferent area of the skin each day.
• Leave the patch on the skin for 24 hours, then remove it and put on a new one.
• Change the patchapproximatelyat the same time every day.
• Do not cut the Neupro patches into pieces.

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

To prevent the patch from peeling off or falling off

• Do notput the patch in an area where it may be subject tofriction from tight clothing.

• Do notusecreams, oils, lotions, powdersor any otherskin productwhere you are going toput the patch. Nor on top of or near another patch that you are already using.

• If you need to put a patch on an area of the skin where you have hair, at least3 days beforeputting it on that site you shouldshave(depilate) the skin area.

• If the edges of the patch start to peel off, you can stick the patch with adhesive tape.

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

• You mustavoidthe area of thepatch from getting too hot- for example, too much sunlight, saunas, hot baths, hot compresses, or hot water bottles. This is because the medication could be released too quickly. If you think it has gotten too hot, contact your doctor or pharmacist.
• Always check that the patch has not fallen off after activities such asbathing, showering, or exercising.
• If the patch hasirritated your skin, you mustkeep the irritated areaprotected from direct sunlight. This is because exposure to the sun could cause changes in the skin's color.

How to use the patch

• Each patch is individually packaged in a sachet.

• Before opening the sachet, you must decide where you are going to put the new patch and check that the used patch has been removed.

• When you have opened the sachet and removed the disposable cover from the patch, you must put the patch on the skin immediately.

How to remove the used patch

• Remove the used patch slowly and carefully.

• Wash the area gently with warm water and a mild soap. This way you will remove any remaining adhesive from the skin. You can also use a little baby oil to remove any remaining adhesive.

• Do not use alcohol or other solvents - such as nail polish remover. This could irritate your skin.

Using more Neupro than you should

Using higher doses of Neupro than your doctor has indicated can cause side 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.

Report this to your doctor or go to the hospital as soon as possible. They will tell you what to do.

Forgetting 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. Remove the used patch and put on a new one.

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

In both cases, the next day put on a new one at the usual time. Do not use a double dose to make up for the missed doses.

Stopping treatment with Neupro

Do not stop using Neupro without first consulting your doctor. Sudden discontinuation could cause a condition called ‘neuroleptic malignant syndrome’ that could put your life at risk. The signs include: loss of muscle movement (akinesia), muscle stiffness, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, and decreased consciousness (for example, coma).

If your doctor tells you to stop treatment with Neupro, thedaily doseof Neupro mustbe reduced gradually:

• 1 mg every two days – if you use Neupro for theRestless Legs Syndrome

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Inform your doctor or pharmacist if you notice any side effects.

Most likely side effects at the start of treatment

You may experiencenauseaandvomitingat the start of treatment. These side effects are usually mild or moderate and do not last long. You shouldconsult your doctorif the side effects last a long time or if they worry you.

Skin problems caused by the patch

• You may experience redness and itching in the area of the skin where the patch has been applied – these reactions are usually mild or moderate.

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

• Consult your doctorif you have a skin reaction that lasts more than a few days, is severe, or spreads beyond the area covered by the patch.

• Avoid exposure to the sun and sunlamps in areas of skin that show any type of reaction caused by the patch.

• To help prevent skin reactions, you should put the patch in a different place each day, and only use the same area again after 14 days.

You may experience loss of consciousness

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

Changes in behavior and abnormal thoughts

Inform your doctor if you notice any change in behavior, thought, or both, as indicated below.

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

If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to tell a family member or caregiver that you are using this medicine and to read the leaflet. Neupro can cause anxiety or an urgent need to behave in anunusual way and not be able to control the impulse, attack, or temptation to perform certain actions that may harm you or others.

These actions may include:

• Strong addiction to gambling – even seriously affecting you or your family

• Altered or increased sexual interest and behavior that causes great concern for you and others – for example, increased sexual desire

• Uncontrolled purchases or excessive spending

• Episodes of 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 can cause other abnormal behaviors and thoughts, which may include:

• Abnormal thoughts about reality

• Delusions and hallucinations (seeing or hearing things that are not real)
• Confusion

• Disorientation

• Aggressive behavior
• Agitation

• Delirium.

Inform your doctor if you notice any change in your behavior, thought, or both, as indicated above.

Your doctor will tell you 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.

Side effects if using Neupro for Restless Legs Syndrome

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

• Headache
• Nausea

• Feeling of weakness (fatigue)

• Irritations of the skin in the area of application of the patch, such as redness and itching

Frequent: may affect up to 1 in 10 patients

• Itching

• Feeling of irritability
• Allergic reaction

• Increased sexual desire

• Increased blood pressure
• Vomiting, heartburn

• Swelling in the legs and feet

• Drowsiness, falling asleep suddenly without warning, difficulty sleeping, unusual dreams, nightmares

• Loss of control over the impulse to perform a harmful action, including addiction to gambling, repetitive actions without sense, compulsive purchases or excessive spending

• Episodes of 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)

Rare: may affect up to 1 in 100 patients

• Feeling agitated

• Feeling dizzy when standing up due to a drop in blood pressure

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

• Aggressive behavior
• Disorientation

Not known:does not know how often they occur

• Anxiety about taking high doses of medicine like Neupro – more than needed for the treatment of the disease. This is known as ‘dopaminergic dysregulation syndrome’ and can lead to excessive use of Neupro.
• Seeing or hearing things that are not real (hallucinations)
• Nightmares
• Paranoia
• Confusion
• Psychotic disorders
• Delusions
• Delirium
• Dizziness
• Loss of consciousness, involuntary movements (dyskinesia)
• Involuntary muscle spasms (convulsions)
• Blurred vision
• Visual disturbances such as seeing colors or lights
• Dizziness (feeling like you are spinning)
• Increased heart rate (palpitations)
• Abnormal heart rhythm
• Drop in blood pressure
• Low blood pressure
• Constipation, dry mouth
• Stomach discomfort and pain
• Diarrhea
• Redness, increased sweating
• Generalized itching, skin irritation
• Generalized rash
• Difficulty maintaining or achieving an erection
• Weight loss, weight gain
• Abnormal liver test results or elevated levels
• Increased heart rate
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme mainly found in skeletal muscles)
• Falls
• Rhabdomyolysis (a rare and serious muscle disorder that causes muscle pain, sensitivity, and weakness and may lead to kidney problems)

Inform your doctor or pharmacist if you experience any of these side effects.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the carton box.

Do not store at a temperature above 30°C.

What to do with used and unused patches

Used patches still contain the active ingredient, 'rotigotine', which can be hazardous to others. Fold the used patch with the adhesive side inward. Place the patch in the original pouch and then dispose of it in a safe place, out of the reach of children.out of the reach of children.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Neupro

The active ingredient is rotigotine.

• 1 mg/24 h:

A patch releases 1 mg of rotigotine every 24 hours. Each patch of 5 cm2contains 2.25 mg of rotigotine.

• 3 mg/24 h:

A patch releases 3 mg of rotigotine every 24 hours. Each patch of 15 cm2contains 6.75 mg of rotigotine.

The other components are:

• Polysiloxane, trimethylsilyl silicate copolymerized, povidone K90, sodium metabisulphite (E223), palmitate ofascorbil (E304) and DL-α-tocoferol (E307).
• Protective layer:Film of polyester, siliconized, aluminumized, colored with a layer of pigment (titanium dioxide (E171), pigment yellow 13, pigment red 166, pigment yellow 12) and printed (pigment red146, pigment yellow 180, pigment black 7).
• Disposable coating:Film of transparent polyester coated with fluoropolymer.

Appearance of the product and contents of the package

Neupro is a transdermal patch. It is thin and has three layers. It has a square shape with rounded corners. The outer part is brown and has the imprint Neupro 1 mg/24 h or 3 mg/24 h.

Neupro is available in the following formats:

Carton containers containing 7, 14, 28, 30 or 84 (multi-pack containing 3 containers of 28) patches, each patch is included in an individual envelope.

Only some sizes of containers may be commercially available.

Marketing Authorization Holder

UCB Pharma S.A.

Allée de la Recherche 60

B-1070 Brussels

Belgium

Responsible for manufacturing

UCB Pharma S.A.

Chemin du Foriest

B-1420 Braine l’Alleud

Belgium

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

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