Neupro

Rotigotine.

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 4 mg/24 h, Neupro 6 mg/24 h, or Neupro 8 mg/24 h.
Neupro 2 mg/24 hr: 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 hr: 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 hr: 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 hr: Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 40 cm² contains 18.0 mg of rotigotine.
Excipients/Inactive Ingredients: 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'. Dopamine is a messenger in the brain which is important for movement.

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 should always use this medicine exactly as told by their doctor or pharmacist. Patients should check with their doctor or pharmacist if they are unsure.
Which strength patches to use: The dose of Neupro will depend on the illness (see as follows).
Neupro is available in different strength patches which release the medicine over 24 hours. The strengths 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.
More than one patch may have to be used to reach the dose, as prescribed by the doctor. For prescribed doses higher than 8 mg/24 h, multiple patches must be applied to achieve the final dose. For example, a daily dose of 10 mg/24 h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
The patches should not be cut into pieces.
Treatment of Parkinson's disease: Patients not taking levodopa - early stage of Parkinson's disease: The starting daily dose will be one 2 mg/24 h patch each day. From the second week, the daily dose may be increased by 2 mg each week until the right maintenance dose is achieved. For most patients, the right dose is between 6 mg and 8 mg each day. This is normally reached within 3 to 4 weeks. The maximum dose is 8 mg each day.
Patients taking levodopa - advanced stage of Parkinson's disease: The starting daily dose will be one 4 mg/24 h patch each day. From the second week, the daily dose will be increased by 2 mg each week until the right maintenance dose is achieved. For most patients, the right dose is between 8 mg and 16 mg each day. This is normally reached within 3 to 7 weeks. The maximum dose is 16 mg each day.
If this medicine has to be stopped, see If the patient stops using Neupro as follows.
Where to stick the patch: Put the sticky side of the patch onto clean, dry, healthy skin on the following areas: Shoulder or upper arm; Belly; Flank; Thigh or hip. Make sure to take the old patch off before putting on a new one. Stick the new patch on a different area of the skin each day. Leave the patch on the skin for 24 hours, then take it off and put on a new one. Change the patches at about the same time every day.
To avoid skin irritation: Stick the patch onto a different area of skin each day. For example, put it on the right side of the body one day, then on the left side of the body the next day; or on the upper body one day, then on the lower body the day after that.
Do not stick Neupro on the same area of skin twice within 14 days.
Do not stick the patch on broken or damaged skin or on skin that is red or irritated.
In case of problems with the skin because of the patch, see Skin problems caused by the patch under Side Effects for more information.
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 where the patch will be applied. Also do not use them on or near a patch already on the skin.
If the patch needs to be applied to a hairy area of skin, the area must be shaven at least 3 days before sticking the patch there.
If the edges of the patch lift, the patch may be taped down with adhesive medical tape.
If the patch falls off, put on a new patch for the rest of the day, then replace the patch at the usual time.
Do not let the area of the patch get hot (for example too much sunlight, saunas, hot baths, heating pads or hot-water bottles). This is because the medicine may be released faster. Patients should seek medical advice if they think that too much heat has been applied.
Always check that the patch has not fallen off after activities such as bathing, showering or exercising.
If the patch has irritated the skin, keep that area protected from direct sunlight. This is because it may change the colour of the skin.
How to use the patch: Each patch is packed in a separate sachet. Before opening the sachet, decide where to stick this new patch and check that any old patch has been removed. Stick the Neupro patch onto the skin as soon as the sachet has been opened and the release liner has been removed.
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. Patients should hold the patch in both hands with the release liner facing them.
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 the fingers.
8. Hold the other half of the rigid release liner. Then put the sticky half of the patch onto the 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 the 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 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 the skin. A little baby oil can also be used 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 the skin.
If the patient forgets to change the patch at the usual time: If the patient has forgotten to change the patch at the usual time, it has to be changed as soon as the patient remembers. The old patch should be taken off and a new one should be used.
If the patient has forgotten to stick on a new patch after removing the old one, a new patch should be used as soon as the patient remembers.
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 the patient stops using Neupro: Do not stop using Neupro without talking to the doctor. A sudden stop could lead to neuroleptic malignant syndrome which could be life-threatening. The signs include: akinesia, rigid muscles, fever, unstable blood pressure, tachycardia, confusion, low level of consciousness (such as a coma).
If the doctor advises to stop Neupro, the daily dose should be lowered gradually (lowered by 2 mg every other day).
In case of any further questions on the use of this medicine, patients should seek medical advice.

Using higher doses of Neupro than prescribed by the doctor may cause side effects such as nausea or vomiting, low blood pressure, hallucinations, confusion, very sleepy, involuntary movements and convulsions. In such cases, the patient should contact the doctor or hospital straight away. They will tell the patient what to do.

Neupro should not be used if: the patient is allergic to rotigotine or any of the other ingredients of this medicine (listed in Description); the patient needs to have a magnetic resonance imaging (MRI) scan; the patient needs cardioversion.
Neupro patch must be taken off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium. A new patch can be put on afterwards.

Patients should seek medical advice before using Neupro or in case of symptoms after beginning treatment with Neupro.
Blood pressure should be regularly checked while using Neupro, especially at the start of the treatment. Neupro may affect the blood pressure.
Eyes should be regularly checked while using Neupro. Patients should seek medical advice straight away if they notice any problems with their eyesight between checks.
The dose may need to be changed in patients with serious liver problems. Patients should seek medical advice straight away if their liver problems worsen during treatment.
The patch may cause skin problems (see Skin problems caused by the patch under Side Effects).
The patient may feel very sleepy or fall asleep suddenly (see Driving and using machines as follows).
Dopamine agonist withdrawal syndrome (DAWS): Medicines used to treat Parkinson's disease should be reduced or stopped gradually. After stopping or reducing Neupro treatment, patients should tell their doctor if they experience symptoms such as depression, anxiety, fatigue, sweating or pain.
A drug withdrawal syndrome has been reported during tapering or after discontinuation of dopamine agonists including rotigotine. Limited data suggest that patients with impulse control disorders and those receiving high daily dose and/or high cumulative doses of a dopamine agonist (DA) may be at higher risk for developing DAWS. Withdrawal symptoms do not respond to levodopa, and may include apathy, anxiety, depression, fatigue, sweating, panic attacks, insomnia, irritability and pain. Prior to discontinuation, patients should be informed about potential withdrawal symptoms, and closely monitored during tapering and after discontinuation. In case of severe withdrawal symptoms, temporary re-administration of Neupro at the lowest effective dose to manage these symptoms may be considered.
Loss of consciousness: Neupro can cause loss of consciousness. This can happen especially when Neupro is started or when the dose is increased. Patients should tell their doctor if they lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking: Neupro can cause side effects that change behaviour. It may be helpful to tell a family member or carer that this medicine is being used and to ask them to read the leaflet. This is so that the patient's family or carer can tell the patient or the doctor, if they are worried about any changes in behaviour.
These include: craving for large doses of Neupro or other medicines used to treat Parkinson's disease; unusual urges or cravings which cannot be resisted and that could harm the patient or others; abnormal thinking or behaviour (see Changes in behaviour and abnormal thinking under Side Effects for more information).
Sodium metabisulphite (E223): Neupro contains sodium metabisulphite (E223). Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm.
Driving and using machines: Neupro may make the patient feel very sleepy, and the patient may fall asleep very suddenly. If this happens, the patient should not drive. In isolated cases, people have fallen asleep while driving and this has caused accidents.
Also patients should not use tools or machines if they feel very sleepy, or do anything else which may put others or themselves at risk of serious injury.
Use in Children: Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.

Neupro should not be used if the patient is pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Do not breast-feed during treatment with Neupro. This is because rotigotine may pass into the breast milk and affect the baby. It is also likely to lower the amount of milk produced.
The patient should seek medical advice before using this medicine if she is pregnant or breast-feeding, thinks she may be pregnant, or is planning to have a baby.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Patients should tell their doctor or pharmacist or nurse if they notice any side effects.
Side effects more likely at the start of treatment: Patients may experience nausea and vomiting at the start of treatment. These effects are usually mild or moderate and only last for a short time. Patients should talk to their doctor if they last for a long time or if they are worried about them.
Skin problems caused by the patch: Patients 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 the patch has been removed.
Patients should talk to their doctor if they 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 skin reactions, the patch should be applied on a different area of skin every day, and only use the same area again after 14 days.
Loss of consciousness: Neupro can cause loss of consciousness. This can happen especially when Neupro is started or when the dose is increased. Patients should tell their doctor if they lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking: Patients should tell their doctor if they notice any changes in behaviour, thinking or both, that are listed as follows. They will discuss ways of managing or reducing symptoms.
It may be helpful to also tell a family member or carer that this medicine is being used and to ask them to read the leaflet. This is so that the patient's family or carer can tell the patient or the doctor, if they are worried about any changes in behaviour. Neupro can cause unusual urges or cravings which patients cannot resist such as the impulse, drive or temptation to do things that could harm themselves or others.
These may include: strong impulse to gamble too much even if this seriously affects patients or their family; altered or increased sexual interest and behaviour which causes significant concern to patients or others (for example, an increased sex drive); uncontrolled shopping or spending too much; binge eating or compulsive eating.
Neupro may cause other behaviours and abnormal thinking. These may include: abnormal thoughts about reality; delusions and hallucinations; confusion; disorientation; aggressive behaviour; agitation; delirium.
Allergic reactions: Patients should seek medical advice if they notice signs of an allergic reaction. These can include swelling of the face, tongue or lips.
Drug Withdrawal Syndrome: A cluster of symptoms, such as anxiety, fatigue, sweating, insomnia, panic attacks, depression, apathy, irritability and pain, have been reported during dose reduction/tapered discontinuation (see Dopamine agonist withdrawal syndrome (DAWS) under Precautions).
Side effects when using Neupro for Parkinson's disease: Patients should tell their doctor, pharmacist or nurse if they get any of the following side effects.
Very common (may affect more than 1 in 10 people): headache; sleepiness or dizziness; 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; fatigue, tiredness; palpitation; constipation, dry mouth, heartburn; redness, increased sweating, itching; vertigo; hallucinations; low blood pressure when standing up, high blood pressure; difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams; dyskinesia; fainting, dizziness 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, compulsive eating.
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; agitation, disorientation, confusion or paranoia; increased or abnormal liver test results; sight problems such as seeing colours or lights; increased levels of creatine phosphokinase (CPK).
Rare (may affect up to 1 in 1,000 people): delusion; delirium; irritability; aggressiveness; psychotic disorders; rash over larger parts of the body; convulsion.
Not known (not known how often these happen): dopamine dysregulation syndrome; diarrhoea; dropped head syndrome; rhabdomyolysis.
Reporting of side effects: In case of any side effects, patients should talk to their doctor, pharmacist or nurse. This includes any possible side effects not previously listed. By reporting side effects, patients can help provide more information on the safety of this medicine.

Other medicines and Neupro: Patients should tell their doctor or pharmacist if they are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. If patients are treated with Neupro and levodopa at the same time, some side effects may get more serious. This includes hallucinations, dyskinesia, and swelling of legs and feet.
Do not take the following medicines while using Neupro because they may decrease its effect: antipsychotic medicines, metoclopramide.
Patients should talk to their doctor before using Neupro if they are taking: sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression; medicines that lower blood pressure.
Neupro may decrease blood pressure when standing up. This effect may be worsened by medicines used to lower blood pressure.
Patients should be advised if it is safe to keep taking these medicines 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 is absorbed by the body. Patients should discuss with their doctor if it is safe to drink alcohol while using Neupro.

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.
Do not throw away any medicines via wastewater or household waste. Patients should be advised by their pharmacist on how to throw away medicines no longer used. These measures will help 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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