The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: rotigotineOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Rotigotine Luye 6 mg/24 hours Transdermal patch

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Rotigotine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Rotigotine

Equivalent medicines (same active substance, strength and form)

→ Neupro 6 mg/24 h transdermal patch brand

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for What Rotigotine Luye is Rotigotine Luye 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. What Rotigotine Luye is used for Rotigotine Luye is used in adults to treat the signs and symptoms of:

Parkinson's disease – Rotigotine Luye can be used on its own or with another medicine called levodopa.

What you need to know before you take it

e Rotigotine Luye Do not use Rotigotine Luye if:

you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
you need 'cardioversion' (specific treatment for abnormal heart beat). You must take your Rotigotine Luye patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on afterwards. If any of the above apply to you, do not use Rotigotine Luye. If you are not sure about this, talk to your doctor or pharmacist first. Warnings and precautions Talk to your doctor or pharmacist before using Rotigotine Luye. This is because:
your blood pressure needs checking regularly while using Rotigotine Luye, especially at the start of the treatment. Rotigotine Luye may affect your blood pressure.
your eyes need checking regularly while using Rotigotine Luye. If you notice any problems with your eyesight between checks, talk to your doctor straight away.
if you have serious liver problems, your doctor may need to change the dose. If your liver problems get worse during treatment, talk to your doctor straight away.
you may get 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.
you may get involuntary muscle contractions causing abnormal, often repetitive movements or postures (dystonia), posture abnormal or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to adjust your medication. If you experience these symptoms after beginning treatment with Rotigotine Luye contact your doctor. Medicines used to treat Parkinson's disease should be reduced or stopped gradually. Tell your doctor if after stopping or reducing your Rotigotine Luye treatment you experience symptoms such as depression, anxiety, fatigue, sweating or pain. Loss of consciousness can occur Rotigotine Luye can cause loss of consciousness. This can happen especially when you start using Rotigotine Luye or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. Changes in behaviour and abnormal thinking Rotigotine Luye can cause side effects that change your behaviour (how you act). You may find it helpful to tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour. These include:
craving for large doses of Rotigotine Luye or other medicines used to treat Parkinson's disease
unusual urges or cravings which you cannot resist and that could harm yourself or others
abnormal thinking or behaviour See 'Changes to your behaviour and abnormal thinking' in section 4 for more information. Children and adolescents 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. Other medicines and Rotigotine Luye Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. If you are treated with Rotigotine Luye and levodopa at the same time, some side effects may get more serious. This includes seeing or hearing things that are not real (hallucinations), movements you cannot control related to Parkinson's disease ('dyskinesia'), and swelling of legs and feet. Do not take the following medicines while using Rotigotine Luye – because they may decrease its effect:
'anti-psychotic' medicines – used to treat certain mental illnesses
metoclopramide – used to treat nausea (feeling sick) and vomiting. Talk to your doctor before using Rotigotine Luye if you are taking:
sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
medicines that lower blood pressure. Rotigotine Luye may decrease blood pressure when you stand up – this effect may be worsened by the medicines used to lower blood pressure. Your doctor will let you know if it is safe to keep taking these medicines while using Rotigotine Luye. Rotigotine Luye with food, drink and alcohol Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body. You should discuss with your doctor if it is safe for you to drink alcohol while using Rotigotine Luye. Pregnancy and breast-feeding Do not use Rotigotine Luye if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are not known. Do not breast-feed during treatment with Rotigotine Luye. This is because rotigotine may pass into your breast milk and affect your baby. It is also likely to lower the amount of milk you produce. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Driving and using machines Rotigotine Luye may make you feel very sleepy and you may fall asleep very suddenly. If this happens, do not drive. In isolated cases, people have fallen asleep while driving and this has caused accidents. Also do not use tools or machines if you feel very sleepy – or do anything else which may put others or yourself at risk of serious injury.

3. How to use Rotigotine Luye Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Which strength patches to use The dose of Rotigotine Luye will depend on your illness – see below. Rotigotine Luye 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.

You may have to use more than one patch to reach your dose, as prescribed by your doctor.
For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths), multiple patches must be applied to achieve the final dose. For example a daily dose of 10 mg 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
Your starting daily dose will be one 2 mg/24 h patch each day.
From the second week your daily dose may be increased by 2 mg each week – until you get to the right maintenance dose for you.
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
Your starting daily dose will be one 4 mg/24 h patch each day.
From the second week your daily dose will be increased by 2 mg each week – until you get to the right maintenance dose for you.
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 you have to stop taking this medicine, see 'If you stop using Rotigotine Luye' in section 3. How to use the Rotigotine Luye patches: Rotigotine Luye is a patch that is put on the skin.
Make sure that you 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 your skin for 24 hours, then take it off and put on a new one.
Change the patches at about the same time every day.
Do not cut the patches into pieces.

Where to stick the patch Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:

Shoulder or upper arm
Belly
Flank (your side, between the ribs and hips)
Thigh or hip

To avoid skin irritation

Stick the patch onto a different area of skin each day. For example, put it on the right side of your body one day, then on the left side of your body the next day. Or on your upper body one day, then on your lower body the day after that.
Do not stick the patch 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. If you still get problems with your skin because of the patch, please see 'Skin problems caused by the patch' in section 4 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 you will put the patch. Also do not use them on or near a patch you are already wearing.
If you need to stick the patch to a hairy area of skin, you must shave the area 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. If you think that too much heat has been applied, 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, 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 you are going to stick this new patch and check you have removed any old patch.
Stick the Rotigotine Luye patch onto your skin as soon as you have opened the sachet, removed the cover sheet and the release liner.

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. Remove the cover sheet from the top, tan-coloured side of the patch and discard it. A protective transparent liner (release liner) covers the sticky side of the patch.

5. Hold the patch in both hands with the transparent release liner facing you. Peel off one side of the release liner and do not touch the sticky part of the patch with the fingers.

6. Put the sticky side of the patch on the skin and then peel off the second side of the release liner.

7. Press the patch down firmly with the palm of your hand. Keep it pressed for about 30 seconds. This makes sure the patch is touching the skin and the edges stick down well. Wash your hands with soap and water straight after handling the patch.

How to take it

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 your skin. You can also use a little baby oil 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 your skin. If you use more Rotigotine Luye than you should Using higher doses of Rotigotine Luye than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions. In such cases, contact your doctor or hospital straight away. They will tell you what to do. If you forget 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.
Take off the old patch and use a new one.
If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember. 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 you stop using Rotigotine Luye Do not stop using Rotigotine Luye without talking to your doctor. A sudden stop could lead to a medical condition called 'neuroleptic malignant syndrome' which could be life-threatening. The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma). If your doctor says you should stop Rotigotine Luye, the daily dose should be lowered gradually:
Parkinson's disease – lowered by 2 mg every other day. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist or nurse if you notice any side effects. Side effects more likely at the start of treatment You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or moderate and only last for a short time. Talk to your doctor if they last for 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 – these reactions are usually mild or moderate.
The reactions normally go away after a few hours – once you remove the patch.
Talk to your doctor if you 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 the skin reactions, you should put the patch on a different area of skin every day, and only use the same area again after 14 days. Loss of consciousness can occur Rotigotine Luye can cause loss of consciousness. This can happen especially when you start using Rotigotine Luye or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy. Changes in behaviour and abnormal thinking Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. Your doctor will discuss ways of managing or reducing symptoms. You may find it helpful to tell also a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour. Rotigotine Luye can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others. These may include:
strong impulse to gamble too much – even if this seriously affects you or your family
altered or increased sexual interest and behaviour which causes significant concern to you or others
for example, an increased sex drive
uncontrolled shopping or spending too much
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 your hunger). Rotigotine Luye may cause other behaviours and abnormal thinking. These may include:
abnormal thoughts about reality
delusions and hallucinations (seeing or hearing things that are not real)
confusion
disorientation
aggressive behaviour
agitation
delirium Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. Your doctor will discuss ways of managing or reducing symptoms. Allergic reactions Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, tongue or lips.

Possible side effects

when using Rotigotine Luye for Parkinson's disease Tell your doctor, pharmacist or nurse if you get any of the following side effects: Very common: may affect more than 1 in 10 people

headache
feeling sleepy or dizzy
feeling sick (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
feeling weak (fatigue), feeling tired
feeling of heartbeat (palpitation)
constipation, dry mouth, heartburn
redness, increased sweating, itching
vertigo (sensation of whirling motion)
seeing or hearing things that are not real (hallucinations)
low blood pressure when standing up, high blood pressure
difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams
movements you cannot control related to Parkinson's disease (dyskinesia)
fainting, feeling dizzy 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 (eating large amount of food in a short period of time), compulsive eating (eating more food than normal and more than needed to satisfy hunger) 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
feeling agitated, disorientated, confused or paranoid
increased or abnormal liver test results
sight problems 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 people
delusion
delirium
feeling irritable
being aggressive
psychotic disorders
rash over larger parts of the body
involuntary muscle spasms (convulsion) Not known: it is not known how often these happen
craving large doses of medicines like Rotigotine Luye – more than needed for the illness. This is known as 'dopamine dysregulation syndrome' and can lead to use of too much Rotigotine Luye.
diarrhoea
dropped head syndrome
rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems) Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Rotigotine Luye

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 box. This medicine does not require any special storage conditions. What to do with the used and unused patches

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, out of the reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Rotigotine Luye contains The active substance is rotigotine.

4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 18.4 cm2 contains 7.36 mg of rotigotine.
6 mg/24 h: Each patch releases 6 mg of rotigotine per 24 hours. Each patch of 27.6 cm2 contains 11.04 mg of rotigotine.
8 mg/24 h: Each patch releases 8 mg of rotigotine per 24 hours. Each patch of 36.8 cm2 contains 14.72 mg of rotigotine. The other ingredients are:
Backing film: pigmented polyethylene aluminium vapor coated polyester, orange printing ink
Matrix layer, containing the active substance: tocopherol, paraffin, povidone K90, silicone adhesive
Release liner: polyester film, fluorosilicone coated
Cover sheet: polyester film, fluorosilicone coated What Rotigotine Luye looks like and contents of the pack Rotigotine Luye is a transdermal patch. It is a thin, rectangular patch with rounded corners. The outside is tan-coloured and is imprinted with 4 mg/24 h: "Rotigotine 4 mg/24 h" 6 mg/24 h: "Rotigotine 6 mg/24 h" 8 mg/24 h: "Rotigotine 8 mg/24 h". Rotigotine Luye is available in the following pack-sizes: Boxes containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder Luye Pharma Ltd. 40 Occam Road Guildford, GU2 7YG UK Manufacturer Luye Pharma AG Am Windfeld 35 83714 Miesbach Germany This leaflet was last revised in August 2024

PIL_ROT_4_6_8_UK_v03

Frequently asked questions about Rotigotine Luye 6 mg/24 hours Transdermal patch

How do I take Rotigotine Luye 6 mg/24 hours Transdermal patch?

Rotigotine Luye 6 mg/24 hours Transdermal patch comes as patch containing 6mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Rotigotine Luye 6 mg/24 hours Transdermal patch?

The active substance in Rotigotine Luye 6 mg/24 hours Transdermal patch is rotigotine.

Are there equivalent medicines to Rotigotine Luye 6 mg/24 hours Transdermal patch?

Medicines with the same active substance, strength and form include: Neupro 6 mg/24 h transdermal patch. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Rotigotine Luye 6 mg/24 hours Transdermal patch, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Rotigotine Luye 6 mg/24 hours Transdermal patch without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: rotigotine
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Rotigotine (12 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Rotigotine Luye 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).

4.2. Posology and method of administration

Posology

The dose recommendations made are in nominal dose.

Dosing in patients with early-stage Parkinson's disease:

A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h.

4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively.

The maximum dose is 8 mg/24 h.

Dosing in patients with advanced stage Parkinson's disease with fluctuations:

A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h.

4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.

For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.

Rotigotine Luye is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.

If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day.

Treatment discontinuation

Rotigotine Luye should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Rotigotine Luye (see section 4.4).

Special populations

Hepatic impairment

Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment.

Renal impairment

Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).

Paediatric population

There is no relevant use of Rotigotine Luye in the paediatric population in Parkinson's disease.

Method of administration

Rotigotine Luye is for transdermal use.

The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Rotigotine Luye should not be placed on skin that is red, irritated or damaged (see section 4.4).

Use and handling

Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin. Then, the patch is fold back and the second part of the release liner is removed. The sticky side of the patch should not be touched. The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.

The patch should not be cut into pieces.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Magnetic resonance imaging or cardioversion (see section 4.4).

4.4. Special warnings and precautions for use

If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)

Magnetic resonance imaging and cardioversion

The backing layer of Rotigotine Luye contains aluminium. To avoid skin burns, Rotigotine Luye should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.

Orthostatic hypotension

Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/ orthostatic hypotension. These events have also been observed during treatment with rotigotine, but the incidence was similar to that observed in placebo-treated patients.

It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.

Syncope

In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.

Sudden onset of sleep and somnolence

Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported. Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination of therapy should be carefully considered.

Impulse control and other related disorders

Patients should be regularly monitored for the development of impulse control disorders and related disorders including dopamine dysregulation syndrome. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. In some patients, dopamine dysregulation syndrome was observed under the treatment with rotigotine. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

Neuroleptic malignant syndrome

Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Therefore, it is recommended to taper treatment (see section 4.2).

Dopamine agonist withdrawal syndrome

Symptoms suggestive of dopamine agonist withdrawal syndrome (for example, pain, fatigue, depression, sweating, and anxiety) have been reported with abrupt withdrawal of dopaminergic therapy, therefore, it is recommended to taper treatment (see section 4.2).

Abnormal thinking and behaviour

Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.

Fibrotic complications

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when treatment is discontinued, complete resolution does not always occur. Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.

Neuroleptics

Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).

Ophthalmologic monitoring

Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.

Heat application

External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.

Application site reactions

Application site skin reactions may occur and are usually mild or moderate in intensity. It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body). The same site should not be used within 14 days. If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.

If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color.

If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Rotigotine Luye is observed, Rotigotine Luye should be discontinued.

Peripheral oedema

In clinical studies in Parkinson's patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months.

Dopaminergic adverse reactions

The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson's patients. This should be considered when prescribing rotigotine.

Dystonic reactions

Dystonic reactions including dystonia, abnormal posture, torticollis and pleurothotonus (Pisa Syndrome) have occasionally been reported in patients with Parkinson's disease following initiation or incremental dose increase of rotigotine. Although dystonic reactions may be a symptom of Parkinson's disease, the symptoms in some of these patients have improved after reduction or withdrawal of rotigotine. If a dystonic reaction occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of rotigotine considered.

4.5. Interaction with other medicinal products and other forms of interaction

Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Rotigotine Luye, and co-administration should be avoided. Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.

Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.

Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.

Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.

Rotigotine Luye may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate pre-existing dyskinesia, as described with other dopamine agonists.

Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).

Interactions with other forms of hormonal contraception have not been investigated.

4.6. Fertility, pregnancy and lactation

Women of childbearing potential, contraception in females

Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.

Pregnancy

There are no adequate data from the use of rotigotine in pregnant women. Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses (see section 5.3). The potential risk for humans is unknown. Rotigotine should not be used during pregnancy.

Breast-feeding

Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected. Studies in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. In the absence of human data, breast-feeding should be discontinued.

Fertility

For information on fertility studies, please see section 5.3.

4.7. Effects on ability to drive and use machines

Rotigotine may have major influence on the ability to drive and use machines.

Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to drive or engage in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).

4.8. Undesirable effects

Summary of the safety profile

Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 patients treated with rotigotine transdermal patch and 607 placebo-treated patients, 72.5% of the patients on rotigotine transdermal patch and 58.0% of patients on placebo reported at least one adverse reaction.

At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.

Adverse drug reactions (ADRs) reported in more than 10% of patients treated with rotigotine transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.

In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the rotigotine transdermal patch, experienced application site reactions. The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with rotigotine patch in only 4.3% of all subjects receiving rotigotine transdermal patch.

Tabulated list of adverse reactions

The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Parkinson's disease and from post-marketing experience. Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System/organ classes acc. To MedDRA

Very common

Common

Uncommon

Rare

Not known

Immune system disorders

Hypersensitivity, which may include angioedema, tongue oedema and lip oedema

Psychiatric disorders

Perception disturbancesa (incl. hallucination, hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulse-control disordersa,d (incl. pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)

Sleep attacks/ sudden onset of sleep, paranoia, sexual desire disordersa (incl. hypersexuality, libido increased), confusional state, disorientationd, agitationd

Psychotic disorder, obsessive- compulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd

Dopamine dysregulation syndromec

Nervous system disorders

Somnolence, dizziness, headache

Disturbances in consciousness NECa (incl. syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy

Convulsion

Dropped head syndromec,e

Eye disorders

Vision blurred, visual impairment, photopsia

Ear and labyrinth disorders

Vertigo

Cardiac disorders

Palpitations

Atrial fibrillation

Supraventricular tachycardia

Vascular disorders

Orthostatic hypotension, hypertension

Hypotension

Respiratory, thoracic and mediastinal disorders

Hiccups

Gastrointestinal disorders

Nausea, vomiting

Constipation, dry mouth, dyspepsia

Abdominal pain

Diarrhoeac

Skin and subcutaneous tissue disorders

Erythema, hyperhidrosis, pruritus

Pruritus generalised, skin irritation, dermatitis contact

Rash generalised

Reproductive system and breast disorder

Erectile dysfunction

General disorders and administration site conditions

Application and instillation site reactionsa (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)

Oedema peripheral, asthenic conditionsa (incl. fatigue, asthenia, malaise)

Irritability

Investigations

Weight decreased

Hepatic enzyme increased (incl. AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd

Injury, poisoning and procedural complications

Fall

Musculoskeletal and connective tissue disorders

Rhabdomyolysisc

a High Level Term

b Observed in open-label studies

c Observed during post-marketing

d Observed in 2011 data pool of double-blind placebo-controlled studies

Description of selected adverse reactions

Sudden onset of sleep and somnolence

Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes. In isolated cases “sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents (see also sections 4.4 and 4.7).

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions and other signs of central dopaminergic stimulation.

Management

There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal of the patch(es) should be considered because after removal of the patch(es) the active substance input is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.

Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis would not be expected to be beneficial as rotigotine is not eliminated by dialysis.

If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic malignant syndrome.

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