Neupro

Rotigotine.

Neupro 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.
Neupro 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.
Neupro 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.
Neupro 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 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
Release liner: Transparent fluoropolymer coated polyester film.

Neupro contains the active substance rotigotine. It belongs to a group of medicines called dopamine agonists which stimulate a certain type of cells and bind with dopamine receptors in the brain.

Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).

Patients Not Taking Levodopa: Early Stage of Parkinson's Disease: Start by using one Neupro 2 mg/24 h patch daily. From the second week, the daily dose will be increased by 2 mg, on a weekly basis, until reaching the right (maintenance) dose. For most patients, the right dose is between 6 mg and 8 mg per day (reached within 3 to 4 weeks).
The maximum dose is 8 mg per day.
Patients Taking Levodopa: Advanced Stage of Parkinson's Disease: Sart by using one Neupro 4 mg/24 h patch daily. From the second week, the daily dose will be increased by 2 mg, on a weekly basis, until reaching the right (maintenance) dose. For most patients, the right dose is between 8 mg and 16 mg per day (reached within 3 to 7 weeks).
The maximum dose is 16 mg per day.
If Neupro has to be discontinued, see Treatment Discontinuation.
Treatment Discontinuation: Do not stop Neupro suddenly without talking to the doctor. A sudden stop could cause development of neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: Akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma).
The daily dose of Neupro should be reduced gradually by 2 mg every other day.
For further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Administration: Neupro is applied once a day. For higher doses, multiple patches must be applied. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hrs and will then be replaced by a new one at a different site of application. Changing of the patch should also be done at around the same time everyday. Do not cut the Neupro patches into pieces.
The patch should be applied to clean, dry, healthy skin on the shoulder, upper arm, belly, thigh, hip, flank (at the side, between the ribs and hip).
Reapplication to the same site within 14 days should be avoided. Neupro should not be placed on skin that is red, irritated or damaged.
To prevent the patch becoming loose or falling off: Do not put the patch in an area where it can be rubbed by tight clothing.
Do not use creams, oils, lotions, powders or other skin products on the area of skin under or near the patch.
In case of sticking the patch in a hairy area of skin, shave the area at least 3 days before sticking the patch.
If the patch falls off, a new patch should be applied for the rest of the day, then replace the patch at the same time as usual.
Note: Bathing, showering and exercising should not affect how Neupro works. Nevertheless, check that the patch has not fallen off afterwards.
Avoid external heat (for example excessive sunlight, saunas, hot baths heating pads or hot-water bottles) on the area of the patch.
If the patch has irritated the skin, keep that area protected from direct sunlight, as it may cause changes in the colour of the skin.
How to Use the Patch: Each patch is packed in a separate sachet. Stick Neupro onto the skin as soon as the sachet has been opened and the release liner has been removed.
To open the sachet, hold the two sides of the sachet. Peel apart the foil and open the sachet.
Take the patch out of the sachet.
The sticky side of the patch is covered by a transparent release liner. Hold the patch in both hands with the release liner facing the patient.
Bend the patch in half so that the S-shaped break in the liner opens.
Peel off one side of the release liner. Do not touch the sticky side of the patch with fingers.
Hold the other half of the rigid release liner and put the sticky surface of the patch onto the skin. Press the sticky side of the patch firmly into place.
Fold back the other half of the patch and remove the other side of the release liner.
Press the patch down firmly with the palm of hand for about 20 to 30 seconds to make sure the patch is touching the skin and the edges stick well.
Wash hands with soap and water immediately after handling the patch.
Removing the Patch: Slowly and carefully peel off the used patch.
Gently washing the area with warm water and mild soap should remove any adhesive that stays on the skin after removing the patch. A small amount of baby oil can also be used to remove any adhesive that would not wash off.
Do not use alcohol or other dissolving liquids such as nail polish remover as these may irritate the skin.
Choose a new area of skin where a new patch will be applied, then follow the instructions as mentioned.
If the patch was not changed at the usual time, change it as soon as it was remembered: Remove the old patch and use a new one. If sticking a new patch after removing the old one is forgotten, use a new patch as soon as it was remembered.
In both cases, on the following day, use a new patch at the usual time. Do not use a double dose to make up for a forgotten dose.

Using higher doses of Neupro than the doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion, extreme sleepiness, involuntary movements and convulsions.
If more patches have been used than the doctor has prescribed, contact the doctor or hospital for advice immediately, and follow their advice on removal of patches.

Hypersensitivity to rotigotine or any of the other ingredients of this medicine (listed in Description).
Magnetic resonance imaging (method to visualise internal organs and tissues of the body) or cardioversion (treatment of abnormal heart rhythm). The patient must take the Neupro patch off before such procedures and can put a new patch on after the procedure.

Talk to the doctor, pharmacist or nurse before using Neupro.
This medicine may affect blood pressure, so it should be measured regularly, especially at the beginning of treatment.
Loss of consciousness can occur. This can happen especially when the patient starts using Neupro or when the dose is increased. Tell the doctor if the patient loses consciousness or feel dizzy.
Eye examinations are recommended at regular intervals while using Neupro. However, if the patient notices any problems with the sight in-between examinations, contact the doctor immediately.
If the patient has serious liver problems, the doctor may need to adjust the dose. If the liver problems get worse during treatment, contact the doctor as soon as possible.
If the patient feels very drowsy or find that he/she falls asleep suddenly, please contact the doctor (see also Driving and using machines as follows).
Tell the doctor if the patient or the patient's family/carer notices developing urges or cravings to behave in ways that are unusual for the patient and cannot resist the impulse, drive or temptation to carry out certain activities that could harm himself/herself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormal high sex drive or preoccupation with an increase in sexual thoughts or feelings. The doctor may need to adjust or stop the dose.
Neupro may cause abnormal thinking and behaviour. This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including abnormal thoughts about reality, delusions, hallucinations (seeing or hearing things that are not real), confusion, disorientation, aggressive behaviour, agitation, and delirium. If the patient notices such effects, please contact the doctor.
Neupro can cause skin reactions, such as reddening and itching. They are usually mild or moderate, and only affect the area of skin the patch has been on. The reactions normally disappear after a few hours when you remove the patch. If the patient has a skin reaction which lasts for more than a few days, is severe, or spreads outside the area of skin that was covered by the patch, please contact the doctor.
Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by Neupro. To help avoid the skin reactions, put the patch on a different area of skin every day, and only use the same area again after 14 days.
Neupro contains sodium metabisulphite (E223): Sodium metabisulphite (E223) may rarely cause severe hypersensitivity reactions and bronchospasm.
Driving and using machines: Neupro may make the patient feel very drowsy, and may fall asleep very suddenly. If this affects the patient, do not drive or take part in activities where not being alert may put the patient or others at risk of serious injury, for example, using machines.
In isolated cases people have fallen asleep while driving and this has caused accidents.
Children and adolescents: Neupro should not be used by children because its safety and efficacy has not been established in children.
Pregnancy and breast-feeding: If pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Do not use Neupro if the patient is pregnant, as the effects of rotigotine on pregnancy and the unborn baby are not known. Breast-feeding is not recommended during treatment with Neupro. Rotigotine may pass into the breast milk and affect the baby and is also likely to reduce the amount of milk produced.

If pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Do not use Neupro if the patient is pregnant, as the effects of rotigotine on pregnancy and the unborn baby are not known. Breast-feeding is not recommended during treatment with Neupro. Rotigotine may pass into the breast milk and affect the baby and is also likely to reduce the amount of milk produced.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient may experience nausea (feeling sick) and vomiting at the beginning of treatment. These effects are usually mild or moderate and only last for a short time. Contact the doctor if they last for a long time.
Skin problems caused by the patch: The patient may get skin reactions from the patch such as redness, itching. They are usually mild or moderate and only affect the area of skin the patch has been on. The reactions normally disappear after a few hours when the patch is removed.
If skin reaction lasts longer than a few days, is severe, or spreads outside the area of skin that was covered by the patch, contact the doctor.
The patient may experience the following side effects: Inability to resist the impulse, drive or temptation to perform an action that could be harmful, which may include: strong impulse to gamble excessively despite serious personal or family consequences; altered or increased sexual interest and behaviour of significant concern to the patient or others, for example, an increased sex drive; uncontrolled excessive shopping or spending; 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 hunger).
Tell the doctor if the patient experiences any of these behaviours; he/she will discuss ways of managing or reducing symptoms.
The patient may experience swelling of the face, tongue and/or lips. If these symptoms develop, please contact the doctor.
The following side effects may occur: Very common side effects: may affect more than 1 in 10 people: sleepiness, dizziness, headache; feeling sick (nausea), vomiting; skin irritations under the patch such as redness and itching.
Common side effects: may affect up to 1 in 10 people: seeing or hearing things that are not real (hallucinations); difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams; loss of consciousness, involuntary movements related to Parkinson's disease (dyskinesia), feeling dizzy when standing up because of fall in blood pressure; vertigo (sensation of whirling motion); feeling of heartbeat (palpitation); low blood pressure when standing up, high blood pressure; hiccups; constipation, dry mouth, heartburn; redness, increased sweating, itching; swelling of legs and feet; feeling weak, feeling tired; falling; weight loss; inability to resist the impulse to perform an action that is harmful involving excessive gambling, repetitive meaningless actions, binge eating, compulsive eating and compulsive shopping.
Uncommon side effects: may affect up to 1 in 100 people: allergic reaction; falling asleep suddenly without warning; paranoia; disorientation; agitation; increased sex drive; confusion; blurred vision; visual disturbances such as seeing colours or lights; abnormal heart rhythm; low blood pressure; stomach discomfort and pain; generalised itching, skin irritation; unable to achieve or maintain an erection; increased or abnormal liver function test results; weight increase; increased heart rate; increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles), no information is available in other populations.
Rare side effects: may affect up to 1 in 1,000 people: psychotic disorders, aggressive behaviour/aggression, involuntary muscle spasms (convulsion), generalised rash, irritability, delusion, delirium.
Not known: cannot be estimated from the available data: excessive use of Neupro (craving for large doses of dopaminergic medicines in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome).
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed. By reporting side effects, it can help provide more information on the safety of this medicine.

Other medicines and Neupro: Tell the doctor or pharmacist if taking or have recently taken or might take any other medicines.
Do not take the following medicines while using Neupro, because they may decrease its effect: anti-psychotics (used to treat certain mental conditions) or metoclopramide (used to treat nausea and vomiting).
If treated with Neupro and levodopa at the same time, some side effects may get more serious, such as seeing or hearing things that are not real (hallucinations), involuntary movements related to Parkinson's disease (dyskinesia), and swelling of legs and feet.
Please ask the doctor whether it is safe to: take medicines that lower blood pressure. Neupro may decrease blood pressure when standing up; this effect may worsen by the medicine used to lower blood pressure.
Take sedating medicines (for example, benzodiazepines, medicines used to treat mental conditions or depression) while using Neupro.
Neupro with food, drink and alcohol: Because rotigotine enters the bloodstream through the skin, food or drink does not affect the way this medicine works. Discuss with the doctor if it is safe to drink alcohol while using Neupro.

Keep this medicine out of the sight and reach of children.
What to do with the used and unused patches: Used patches still contain active substance, 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 the pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.

Antiparkinsonian Drugs

N04BC09 - rotigotine ; Belongs to the class of dopamine agonists. Used in the management of Parkinson's disease.

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