ROTIGOTINE LUYE 4 mg/24h TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Rotigotina Luye 4 mg/24 h Transdermal Patches EFG

Rotigotina Luye 6 mg/24 h Transdermal Patches EFG

Rotigotina Luye 8 mg/24 h Transdermal Patches EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rotigotina Luye and what is it used for
2. What you need to know before you use Rotigotina Luye
3. How to use Rotigotina Luye
4. Possible side effects
5. Storing Rotigotina Luye
6. Contents of the pack and other information

1. What is Rotigotina Luye and what is it used for

What is Rotigotina Luye

Rotigotina Luye contains the active substance rotigotine.

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

What is Rotigotina Luye used for

Rotigotina Luye is used in adults to treat the signs and symptoms of:

• Parkinson's disease- Rotigotina Luye can be used alone or with another medicine called levodopa.

2. What you need to know before you use Rotigotina Luye

Do not use Rotigotina Luye if:

• you are allergicto rotigotineor any of the other ingredientsof this medicine (listed in section 6)
• you are going to have a magnetic resonance imaging(MRI) scan (diagnostic images of the inside of the body, created using magnetic energy instead of X-ray energy)
• you need a cardioversion(specific treatment for heart rhythm disturbances).

You must remove the rotigotine patch just before having an MRI scan or cardioversion to avoid skin burns because the patch contains aluminum. You can put on a new patch when these tests are over.

Do not use rotigotine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist first.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use rotigotine, as:

• you should have your blood pressurechecked regularly while you are using rotigotine, especially when starting treatment. Rotigotina Luye may affect your blood pressure.
• • you should have your eyesightchecked regularly while you are using rotigotine. If you notice any problems with your eyesight between checks, you should tell your doctor immediately.
  • if you have serious liver problems, your doctor may need to adjust your dose. If your liver problems get worse while you are using Rotigotina Luye, you should tell your doctor as soon as possible.
  • you may have skin reactionscaused 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 have involuntary muscle contractions that cause abnormal movements or postures, often repetitive (dystonia), abnormal postures or lateral flexion of the spine (also called pleurothotonus or Pisa syndrome). If this happens, your doctor may decide to adjust your medication.

If you experience these symptoms after starting treatment with Rotigotina 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 treatment with Rotigotina Luye, you experience symptoms such as depression, anxiety, fatigue, sweating, or pain.

You may lose consciousness

Rotigotina may cause loss of consciousness. This can happen especially when starting treatment with rotigotina or when increasing the dose. Tell your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Rotigotina Luye may cause side effects that change your behavior (how you act). If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to tell a family member or caregiver that you are using this medicine and to read the leaflet.

This includes:

• an overwhelming urge to consume large doses of Rotigotina Luye or other medicines used to treat Parkinson's disease
• anxiety or an overwhelming urge to behave in an unusual way that you cannot control and that may harm you or others
• abnormal thoughts or behaviors

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

Children and adolescents

This medicine must notbe given to childrenunder 18 years because its safety and efficacy in this age group are unknown.

Other medicines and Rotigotina Luye

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines without a prescription and herbal medicines.

If you are being treated with Rotigotina Luye and levodopa at the same time, some side effects may get worse. This includes seeing or hearing things that are not real (hallucinations), uncontrolled movements related to Parkinson's disease (dyskinesia), swelling in the legs and feet.

Do not take the following medicines while using rotigotina, as they may reduce its effect:

• ‘antipsychotic’ medicines - used to treat certain mental illnesses
• metoclopramide- used to treat nausea and vomiting.

Tell your doctor before using Rotigotina Luye if you are taking:

• sedative medicines such as benzodiazepines or medicines used to treat mental disorders or depression
• medicines that lower blood pressure. Rotigotina may lower blood pressure when standing up - this effect may be worse when taking medicines to lower blood pressure.

Your doctor will tell you if it is safe to take these medicines while using Rotigotina Luye.

Using Rotigotina Luye with food, drinks, and alcohol

Since rotigotine enters the bloodstream through the skin, taking food or drinks does not affect how this medicine is absorbed. You should ask your doctor if you can drink alcohol while using rotigotina.

Pregnancy and breastfeeding

Do not use rotigotina if you are pregnant. This is because the effects of rotigotina on pregnancy and the fetus are not known.

Do not breastfeed while using rotigotina. This is because rotigotina may pass into breast milk and affect your baby. It may also reduce the amount of milk produced.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Rotigotina may make you feel very sleepy or fall asleep suddenly. If this happens, do not drive. In rare cases, some people have fallen asleep while driving, which has led to accidents.

Also, do not use tools or machines if you feel very sleepy - or perform any activity that may put you or others at risk of serious injury.

3. How to use Rotigotina Luye

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

What patch dose to use

The dose of Rotigotina Luye you need depends on your illness - see below.

Rotigotina Luye is available in patches of different doses that release the medicine over 24 hours. The doses 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 need to use more than one patch to reach the dose prescribed by your doctor.
• For doses above 8 mg/24 h (doses prescribed by your doctor above the available doses), several patches must be used to reach the final dose. For example, a daily dose of 10 mg can be achieved using a 6 mg/24 h patch and a 4 mg/24 h patch.
• Patches cannot be cut into pieces.

Treatment of Parkinson's disease

Patients who are not taking levodopa - early stages of Parkinson's disease

• Your starting dose will be a 2 mg/24 h patch per day.
• From the second week onwards, the daily dose will be increased by 2 mg weekly - until the appropriate maintenance dose for you is reached.
• For most patients, the appropriate dose is between 6 mg and 8 mg per day. This is usually reached between 3 and 4 weeks.
• The maximum dose is 8 mg per day.

Patients who are taking levodopa - advanced stages of Parkinson's disease

• Your starting dose will be a 4 mg/24 h patch per day.
• From the second week onwards, the daily dose will be increased by 2 mg weekly - until the appropriate maintenance dose for you is reached.
• For most patients, the appropriate dose is between 8 mg and 16 mg per day. This is usually reached between 3 and 7 weeks.
• The maximum dose is 16 mg per day.

If you need to stop taking this medicine, see “If you stop using Rotigotina Luye” in section 3.

How to use the rotigotine patches

Rotigotina Luye is a patch that you apply to your skin.

• Check that you have removed the used patch before applying a new one.
• Apply the new patch to a different area of skin each day.
• Leave the patch on your skin for 24 hours, then remove it and apply a new one.
• Change the patchat about the same time every day.

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Where to apply the patch

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

To prevent the patch from coming off or detaching

• Do notapply the patch to an area where it may be rubbed by tight clothing.
• Do notuse creams, oils, lotions, powdersor any other skin productswhere you will apply the patch. Nor on top of or near another patch that you are already using.
• If you need to apply a patch to an area of skin where you have hair, you should shave(depilate) the area of skin at least 3 days beforeapplying the patch to that site.
• If the edges of the patch come off, you can secure the patch with adhesive tape.

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

• You should avoidthat the patch area gets heated- for example, too much sunlight, saunas, hot baths, hot compresses, or hot water bottles. This is because the medicine could be released more quickly. If you think you have overheated, 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, you should keepthe irritated area protected from direct sunlight. This is because sun exposure could cause changes in skin color.

How to use the patch

• Each patch is packaged individually in a pouch.
• Before opening the pouch, you should decide where you will apply the new patch and check that you have removed the used patch.
• When you have opened the pouch and removed the disposable layer from the patch, you should apply the patch to your skin immediately.

How to remove the used patch

• Remove the used patch slowly and carefully.
• Gently wash the area with warm water and a mild soap. This will remove any remaining adhesive from your skin. You can also use a little baby oil to remove any remaining adhesive.
• Do not use alcohol or other liquid solvents - such as nail polish remover. This could irritate your skin.

If you use more Rotigotina Luye than you should

Using higher doses of Rotigotina Luye than your doctor has told you may cause side effects such as nausea or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), confusion, extreme sleepiness, involuntary movements, and convulsions.

In these cases, tell your doctor or go to the hospital as soon as possible. They will tell you what to do.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to change the patch at the usual time

• If you have forgotten to change the patch at the usual time, change it as soon as you remember. Remove the used patch and apply a new one.
• If you have forgotten to apply a new patch after removing the used patch, apply a new one as soon as you remember.

In both cases, the next day, apply a new patch at the usual time. Do not use a double dose to make up for forgotten doses.

If you stop treatment with Rotigotina Luye

Do not stop using Rotigotina Luye without first consulting your doctor. A sudden interruption could cause a condition called 'malignant neuroleptic syndrome' that can put your life at risk. The signs include: loss of muscle movement (akinesia), muscle stiffness, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, decreased consciousness (e.g., coma).

If your doctor tells you to stop treatment with Rotigotina Luye, the daily doseof Rotigotina Luye should be gradually reduced:

• Parkinson's disease– it should be reduced by 2 mg every two days.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Tell your doctor, pharmacist, or nurse if you notice any side effects.

Most likely side effects at the start of treatment

You may have nauseaand vomiting at the start of treatment. These effects are usually mild or moderate and last for a short time. You should consult your doctorif the effects last for a long time or if you are concerned.

Skin problems caused by the patch

• Redness and itching may appear in the skin area where the patch has been applied – these reactions are usually mild or moderate.
• These reactions usually disappear a few hours after removing the patch.
• Consult your doctorif you have a skin reaction that lasts for more than a few days, if it is severe, or if it spreads beyond the area covered by the patch.
• Avoid exposure to the sun and sunlamps in skin areas that show any type of reaction caused by the patch.
• To help prevent skin reactions, the patch should be placed on a different site each day, and the same area should only be used again after 14 days.

You may experience loss of consciousness

Rotigotina Luye can cause loss of consciousness. This can happen especially when starting treatment with Rotigotina Luye or when increasing the dose. Tell your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Tell your doctor if you notice any changes in behavior, thinking, or both, as indicated below. Your doctor will tell you how to manage or reduce the symptoms.

If your family or caregiver, or your doctor, are concerned about changes in your behavior, it may be helpful to tell a family member or caregiver that you are using this medication and have them read the package insert. Rotigotina Luye can cause anxiety or an overwhelming need to behave in an unusual way and not be able to control the impulse, attack, or temptation to perform certain actions that can harm you or others.

These actions may include:

• strong addiction to gambling – even seriously affecting you or your family
• altered or increased sexual interest and behavior that causes great concern for you and others - for example, increased sexual desire
• uncontrolled shopping or excessive spending
• episodes of binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Rotigotina Luye can cause other abnormal behaviors and thoughts, which may include:

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

Tell your doctor if you notice any changes in your behavior, thinking, or both, as mentioned above.

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

Allergic reactions

Tell your doctor if you notice signs of an allergic reaction – which can include swelling of the face, tongue, or lips.

Side effects if you use Rotigotina Luye for

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

Very common: may affect more than 1 in 10 patients

• headache
• drowsiness or dizziness
• nausea, vomiting
• skin irritation at the patch application site, such as redness and itching

Common: may affect up to 1 in 10 patients

• falls
• hiccups
• weight loss
• swelling in the legs and feet
• feeling of weakness (fatigue), feeling of tiredness
• increased heart rate (palpitations)
• constipation, dry mouth, heartburn
• redness, increased sweating, itching
• dizziness (feeling of spinning)
• seeing or hearing things that are not real (hallucinations)
• low blood pressure when standing up, high blood pressure
• difficulty staying asleep, sleep disorders, difficulty sleeping, nightmares, strange dreams
• involuntary movements related to Parkinson's disease (dyskinesia)
• loss of consciousness, feeling of dizziness when standing up caused by a drop in blood pressure
• inability to control the impulse to perform a harmful action, including addiction to gambling, meaningless repetitive actions, compulsive shopping, or excessive spending
• episodes of binge eating (eating large amounts of food in a short period), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon: may affect up to 1 in 100 patients

• blurred vision
• weight gain
• allergic reaction
• decreased blood pressure
• increased heart rate
• increased sexual desire
• abnormal heart rhythm
• stomach discomfort and pain
• generalized itching, skin irritation
• sudden sleepiness without warning
• inability to achieve or maintain an erection
• feeling agitated, disoriented, confused, or paranoid
• abnormal liver test results or elevated
• visual disturbances such as seeing colors or lights
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscle).

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

• delusional ideas
• delirium
• feeling of irritability
• aggressive behavior
• psychotic disorders
• rash on large areas of the body
• involuntary muscle spasms (convulsions)

Not known: the frequency is not known

• anxiety about taking high doses of medications like Rotigotina Luye – more than necessary for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and can lead to excessive use of Rotigotina Luye
• diarrhea
• dropped head syndrome
• rhabdomyolysis (a rare, severe muscle disorder that causes pain, sensitivity, and weakness of the muscles and can cause kidney problems)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package insert. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rotigotina Luye

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

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

This medicine does not require special storage conditions

What to do with used and unused patches

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

• Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need at the Sigre collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and information

The active ingredient is rotigotine.

• 4 mg/24 h:

One patch releases 4 mg of rotigotine every 24 hours. Each 18.4 cm2 patch contains 7.36 mg of rotigotine.

• 6 mg/24 h:

One patch releases 6 mg of rotigotine every 24 hours. Each 27.64 cm2 patch contains 11.04 mg of rotigotine.

• 8 mg/24 h:

One patch releases 8 mg of rotigotine every 24 hours. Each 36.8 cm2 patch contains 14.72 mg of rotigotine.

The other components are:

• Support layer: pigmented polyethylene, aluminum vapor-coated polyester, orange printing ink
• Matrix layer containing the active ingredient: tocopherol, paraffin, povidone K90, silicone adhesive
• Release layer: fluorosilicone-coated polyester film
• Coating layer: fluorosilicone-coated polyester film

Appearance of the product and package contents

Rotigotina Luye is a transdermal patch. It is thin, rectangular in shape with rounded corners. The outer part is brown in color and bears the inscription

4 mg/24 hours: “Rotigotine 4 mg/24 h”

6 mg/24 hours: “Rotigotine 6 mg/24 h”

8 mg:24 hours: “Rotigotine 8 mg/24 h”

Rotigotina Luye is available in the following formats:

Packages containing 7, 14, 28, 30, or 84 (multiple package containing 3 packages of 28) patches, each patch is included in an individual envelope.

Only some package sizes may be marketed.

Marketing authorization holder

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Date of the last revision of this package insert: 01/2024

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).