Neupro – Rotigotine uses, dose and side effects


2 mg / 24 hours, 4 mg / 24 hours, 6 mg / 24 hours, 8 mg / 24 hours transdermal patch

What Neupro is and what it is used for

What Neupro is

Neupro contains the active substance rotigotine.

It belongs to a group of medicines called “dopamine agonists”. Dopamine is a neurotransmitter in the brain that is important for the body’s movements.

What Neupro is used for

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

  • Parkinson’s disease – Neupro can be used alone or in combination with another medicine called levodopa .

What you need to know before using Neupro

Do not use Neupro

  • if you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6).
  • if you need to undergo magnetic resonance imaging (MRI) (images on the inside of the body to make a diagnosis. The images are created using magnetic energy instead of X-rays).
  • if you need electrical conversion (specific treatment for abnormal heartbeats).

You must remove the Neupro patch just before undergoing magnetic resonance imaging (MRI) or electrical conversion to avoid burns to the skin as the patch contains aluminum. You can apply a new patch afterward.

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Neupro. The reason is that:

  • Your blood pressure needs to be checked regularly when you use Neupro, especially at the beginning of treatment. Neupro can affect your blood pressure .
  • your eyes need to be checked regularly when using Neupro. If you notice any problems with your vision between examinations, contact your doctor immediately.
  • If you have severe liver problems, your doctor may need to change your dose . Contact your doctor immediately if your liver problems worsen during treatment.
  • you may have skin problems caused by the patch – see “ Skin problems caused by the patch ” in section 4.
  • you may feel very sleepy or fall asleep suddenly – see ” Driving and using machines” in section 2.

If you experience such symptoms either before or after starting treatment with Neupro, contact your doctor

Drugs used in the treatment of Parkinson’s disease should be phased out or discontinued gradually. Tell your doctor if you experience symptoms such as depression, anxiety, fatigue, sweating, or pain after stopping a treatment or reducing the dose of one of Neupro.

Unconsciousness can occur

Neupro may cause unconsciousness. This can happen especially when you start using Neupro or when your dose is increased. Tell your doctor if you have lost consciousness or feel dizzy.

Behavioral changes and abnormal thinking

Neupro can cause side effects that change your behavior (how you act). It may be helpful to tell a family member or caregiver that you are taking this medicine and ask them to read this leaflet. This is so that your family or caregiver can tell you or your doctor if they are worried about changes in your behavior.

These include:

  • request high doses of Neupro or other medicines used to treat Parkinson’s disease
  • unusual urges or desires that you can not resist and that can harm you or others
  • abnormal thinking or behavior

See “ Changes in Your Behavior and Abnormal Thinking” in Section 4 for more information.

Children and young people

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

Other medicines and Neupro

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter and herbal remedies.

If you are being treated with Neupro and levodopa at the same time, some side effects may be more serious. This includes visual and auditory experiences that are not real (hallucinations), movements that you can not control that is associated with Parkinson’s disease ( dyskinesia ), and swelling in the legs and feet.

Do not take the following medicines while using Neupro – they may reduce the effect of Neupro:

  • antipsychotic drugs – used to treat certain mental illnesses
  • metoclopramide – used to treat nausea and vomiting.

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

  • sedatives such as benzodiazepines or medicines to treat mental illness or depression.
  • drugs that lower blood pressure et. Neupro may lower your blood pressure when you stand up – this effect may be exacerbated by medicines used to lower your blood pressure .

Your doctor will tell you if it is safe to continue taking these medicines while you are using Neupro.

Neupro with food, drink and alcohol

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

Pregnancy and breastfeeding

Do not use Neupro if you are pregnant. The reason is that it is not known how rotigotine affects the pregnancy and the unborn baby.

Do not breastfeed during treatment with Neupro. The reason is that rotigotine can pass into breast milk and affect your baby. It is also likely to reduce the amount of milk you produce.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Also, do not use tools or machines if you feel very sleepy – nor do other things that put you or others at risk of serious injury.

Neupro contains excipients

Sodium metabisulfite (E223) can in rare cases cause severe hypersensitivity reactions (allergic reactions) and bronchospasm (shortness of breath caused by narrowing of the airways).

How to use Neupro

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

What strength of the patch to use

The dose of Neupro you receive depends on your illness, see below.

Neupro patches are available in different strengths and release drugs for 24 hours. The strengths are:

2 mg / 24 hours, 4 mg / 24 hours, 6 mg / 24 hours and 8 mg / 24 hours for the treatment of Parkinson’s disease . You may need to use more than one patch to achieve the dose prescribed by your doctor.

Neupro escalator pack contains 4 different packs (one for each strength) with 7 patches in each pack. These packs are usually needed for the first four weeks of treatment, but depending on how you respond to Neupro you may not need to use all dose packs or you may need additional packs for a higher dose after week 4, which are not covered by this pack.

On the first day of treatment, start with Neupro 2 mg / 24 hours (the package is marked “ Week 1 ”) and use a transdermal patch with 2 mg Neupro daily. Neupro 2 mg is taken for 7 days (eg if you start on a Sunday, switch to the next dose pack the following Sunday).

During the second week, take Neupro 4 mg (the package is labeled “ Week 2 ”).

During the third week, take Neupro 6 mg (pack marked “ Week 3 ”).

During the fourth week, take Neupro 8 mg (the pack marked “ Week 4 ”).

Which dose is right for you depends on your needs.

For some patients, 4 mg Neupro per day may be an effective dose. Most patients with early-stage Parkinson’s disease reach the appropriate dose within 3 or 4 weeks, at doses of 6 mg per day and 8 mg per day, respectively. The highest dose is 8 mg per day. Most patients with advanced-stage Parkinson’s disease reach the correct dose within 3-7 weeks at a dose of 8 mg per day, up to a maximum dose of 16 mg per day. For doses higher than 8 mg / 24 hours ( dose higher than the available strengths, as prescribed by your doctor), several patches must be used to achieve the final dose. For example. if you have been given a daily dose of 14 mg, then a dose can be achieved by using a patch with a strength of 6 mg / 24 hours and a patch with a strength of 8 mg / 24 hours. Similarly, a daily dose of 16 mg can be achieved by using two patches with a potency of 8 mg / 24 hours.

If you have to stop using this medicine, read “If you stop using Neupro” in section 3.

How to use Neupro patches

Neupro is a patch that is applied to the skin.

  • Be sure to remove the old patch before applying a new one.
  • Put the new patch on a new area of ​​skin every day .
  • Leave the patch on the skin for 24 hours, then remove it and apply a new one.
  • Change patches at about the same time each day .
  • Do not cut the patch into pieces.
Here you put the patch place the sticky side of the patch on clean, dry, and healthy skin in the following areas, which are shown in gray in the image next to it: The shoulders or upper armsStomachThe abdominal sides (on the side of the body between the ribs and the hips)Thighs or hips
To avoid skin irritation put the patch on a new area of ​​skin every day. For example, put it on the right side of the body one day and then on the left side the next day, or on the upper part of the body one day and the lower part the next day. Do not apply the patch to the same area of ​​skin twice within 14 days. Do not place the patch on cracked or damaged skin – or on skin that is red or irritated

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

To prevent the patch from coming loose or coming loose

  • Do not place the patch in a place where it will rub against tight clothing .
  • Do not use cream , oil, lotion, powder or other skin products where you are going to put the patch. Also, do not use such products on or near a patch that is already on.
  • If you have to put the patch on a hairy skin area, you must shave the skin area for at least three days before applying the patch there.
  • If the edges of the patch come loose, the patch can be taped with medical tape.

If the patch comes off, apply a new patch that will remain for the rest of the day. Then replace this patch at the usual time.

  • Do not expose the area where the patch is exposed to  strong heat – for example, too much sunlight, saunas, hot baths, heating pads or hot water bottles. The reason for this is that the drug can then be released faster. If you have the impression that the patch has been exposed to too much heat, consult your doctor or pharmacist.
  • After bathing, showering and exercising, always check afterwards that the patch has not come off.
  • If the patch has irritated the skin, you should keep that skin area protected from sunlight . The reason is that it can stain the skin.

How to use the patch

  • Each patch is packaged in a separate sachet .
  • Before opening the sachet, decide where to put the new patch and check that you have removed the old one.
  • Apply the Neupro patch to the skin as soon as you have opened the sachet and removed the protective film.
1. To open the sachet, hold it with both hands
2. Pull the foil apart.  
3. Open the sachet.  
4. Remove the patch from the sachet.  
5. The sticky side of the patch is covered with a transparent protective film. Hold the patch with both hands with the protective film facing you.  
6. Fold the patch in half. This opens the S-shaped notch in the film.  
7. Peel off one side of the protective film. Do not touch the sticky side of the patch with your fingers.  
8 . Hold the other half of the rigid protective film. Then place the sticky half of the patch against the skin. Press the sticky side of the patch firmly against the skin.  
9. Fold the other half of the patch back and pull off the other half of the protective film.
10. Place your palm on the patch and press firmly against the skin. Continue pressing for about 30 seconds to make sure that the patch is against the skin and that the edges are firmly attached.
11. Wash your hands with soap and water immediately after handling the patch

How to remove a used patch

  • Slowly and gently pull off the applied patch.
  • Gently wash the area with warm water and mild soap. This will remove any adhesive that remains on the skin. You can also use a little baby oil to remove adhesive that could not be washed off.
  • Do not use alcohol or other solvents – as a nail polish remover. These can irritate the skin.

If you use more Neupro than you should

Using larger doses of Neupro than your doctor has prescribed can lead to side effects such as nausea or vomiting, low blood pressure, unrealistic vision and hearing (hallucinations), feeling confused or very sleepy, involuntary movements, and getting cramps. Contact your doctor or hospital immediately if this happens. They will tell you what to do.

If you have used a different patch (eg Neupro 4 mg / 24 hours instead of Neupro 2 mg / 24 hours) than your doctor advised you to use, contact a doctor or hospital immediately for advice and follow their advice on a change of patches.

Contact your doctor if you experience any unpleasant reactions.

If you forget to change patches at the usual time

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

In both cases, apply a new patch at the usual time the next 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 consulting a doctor. A sudden stop can lead to you developing a medical condition called malignant neuroleptic syndrome which can be life-threatening. Symptoms include the inability to move the muscles ( akinesia ), stiff muscles, fever, unstable blood pressure, increased heart rate ( tachycardia ), confusion, low level of consciousness (such as coma ).

If your doctor tells you to stop taking Neupro, your daily dose should be reduced gradually:

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

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

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 are more common at the beginning of treatment

You may feel sick and vomit at the beginning of the treatment. These side effects are usually mild or moderate and last only a short time. Talk to your doctor if they last 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 applied – these reactions are usually mild or moderate.
  • The reactions usually disappear after a few hours – after you have removed the patch.
  • Talk to your doctor if you get a skin reaction that lasts for more than a few days or is severe.
  • Also talk to your doctor if the skin reaction spreads outside the area where the patch has been applied.
  • Avoid exposing the skin to sunlight and tanning beds in areas that show any type of skin reaction caused by the patch.
  • To avoid skin reactions, place the patch on a new area of ​​skin every day and use the same area again only after 14 days.

Unconsciousness can occur

Neupro may cause unconsciousness. This can happen especially when you start using Neupro or when your dose is increased. Tell your doctor if you have lost consciousness or feel dizzy.

Behavioral changes and abnormal thinking

Tell your doctor if you notice any changes in behavior and/or thinking, as mentioned below. Ways to manage or reduce the symptoms will be discussed.

It may be helpful to tell a family member or caregiver that you are taking this medicine and ask them to read this leaflet. This is so that your family or caregiver can tell you or your doctor if they are worried about changes in your behavior. Neupro can cause unusual urges or cravings that you can not resist, such as an impulse, drive, or temptation to do things that may harm you or others – the symptoms are seen mainly in patients with Parkinson’s disease.

These may include:

  • a strong impulse to play too much – even if this has serious consequences for you or your family
  • changed or increased sexual interest or behavior that makes you or others noticeably worried, such as increased sexual drive
  • uncontrollable need to buy things or spend too much money
  • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Neupro can cause other behaviors and abnormal thinking. These may include:

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

Tell your doctor if you notice any changes in behavior and/or thinking, as mentioned above. Ways to manage or reduce the symptoms will be discussed.

Allergic reactions

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

Side effects are when you use Neupro for Parkinson’s disease

If you get any of the following side effects, talk to your doctor, pharmacist, or nurse.

Very common: may affect more than 1 in 10 people

  • headache
  • feel sleepy or dizzy
  • nausea, vomiting
  • skin reactions under the patch, such as redness and itching

Common: may affect up to 1 in 10 people

  • fall
  • hiccup
  • weight loss
  • swelling in legs and feet
  • feel weak or tired
  • palpitation
  • constipation, dry mouth , heartburn
  • redness , increased sweating, itching
  • dizziness (feeling of rotating motion)
  • visual and auditory experiences that are not real (hallucinations)
  • low blood pressure when getting up, high blood pressure
  • difficulty falling asleep, sleep disturbances, difficulty sleeping, nightmares, unusual dreams
  • movements that you can not control, related to Parkinson’s disease ( dyskinesia )
  • fainting, feeling dizzy when standing up due to a drop in blood pressure
  • inability to resist the impulse to perform a harmful activity including excessive gambling, repeated meaningless actions, uncontrollable need to buy things or spend too much money
  • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than what is needed to satisfy your hunger)

Uncommon: may affect up to 1 in 100 people

  • dimsyn
  • weight gain
  • allergic reactions
  • low blood pressure
  • increased heart rate
  • increased sexual drive
  • abnormal heart rhythm
  • stomach upset and stomach pain
  • general itching , skin irritation
  • suddenly fall asleep without warning
  • inability to get or maintain an erection
  • feeling restless, disoriented, confused or paranoid (feeling persecuted)
  • elevated or abnormal values ​​in liver function tests
  • visual disturbances such as seeing color or light phenomena
  • elevated levels of creatine phosphokinase (CPK) (CPK is an enzyme found primarily in skeletal muscle).

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

  • delusion
  • delirium (severe confusion)
  • feel annoyed
  • be aggressive
  • psychotic disorders
  • skin rash on most of the body
  • involuntary muscle spasms (seizures)

No known frequency: it is not known how often these occur

  • Require high doses of drugs such as Neupro – more than the amount needed for the disease. This is called “dopaminergic dysregulation syndrome” and can lead to the use of too much Neupro.
  • diarrhea
  • dropped head syndrome
  • rhabdomyolysis (a rare, severe muscle disease that causes pain, tenderness and weakness in muscles and can lead to kidney problems)

Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.

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.

How to do it with used and unused patches

  • Used patches still contain active substance, “rotigotine”, which may be harmful to others. Fold the used patch with the sticky side inwards. Put the patch in the sachet and dispose of it safely, out of the reach of children.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

The active substance is rotigotine.

  • 2 mg / 24 hours:Each patch releases 2 mg of rotigotine per 24 hours. Each 10 cm patch contains 4.5 mg of rotigotine.
  • 4 mg / 24 hours:Each patch releases 4 mg of rotigotine per 24 hours. Each 20 cm patch contains 9.0 mg of rotigotine.
  • 6 mg / 24 hours:Each patch releases 6 mg of rotigotine per 24 hours. Each 30 cm patch contains 13.5 mg of rotigotine.
  • 8 mg / 24 hours:Each patch releases 8 mg of rotigotine per 24 hours. Each 40 cm patch contains 18.0 mg of rotigotine.

Other ingredients are:

  • Poly (dimethylsiloxane, trimethylsilyl silicate) copolymer, povidone K90, sodium metabisulfite (E223), ascorbyl palmitate (E304) and DL ‑ α ‑ tocopherol (E307).
  • Outer layer: Siliconized, aluminized, color pigment coated (titanium dioxide E171, pigment yellow 95, pigment red 166) polyester film layer with print (pigment red 144, pigment yellow 95, pigment black 7).
  • Protective film: Transparent fluoropolymer coated polyester film.

What the medicine looks like and contents of the pack

Neupro is a transdermal patch . It is thin and consists of three layers. It is square with rounded corners. The outside is beige and has the text 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:

A package for initial treatment contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, respectively, separately packed in sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

UCB Pharma SA

Research Avenue 60

B-1070 Brussels


Manufacturer :

UCB Pharma SA

Chemin du Foriest

B-1420 Braine l’Alleud


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