Package Insert: Information for the User

Dariante 2 mg/24 h Transdermal PatchesEFG

rotigotina

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Dariante and for what it is used

2. What you need to know before starting to use Dariante

3. How to use Dariante

4. Possible adverse effects

5. Storage of Dariante

6. Contents of the package and additional information

What is Dariante

Dariante contains the active ingredient rotigotine.

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

What is Dariante used for

Dariante is used in adults to treat the symptoms of:

• Parkinson's Disease -Dariante may be used alone or with another medication called levodopa.
• Restless Legs Syndrome (RLS)(RLS) – this syndrome may be associated with leg or arm discomfort, urge to move, sleep disturbances, and feelings of fatigue or sleepiness during the day. Treatment with Dariante reduces or decreases the duration of these symptoms.

Do not use Dariante if:

• You areallergicto rotigotine or any of theother componentsof this medication (listed in section 6)
• You are going to have amagnetic resonance imaging (MRI)scan (diagnostic images of the inside of the body, created using magnetic energy instead of X-ray energy)
• You need acardioversion(specific treatment for heart rhythm disorders).

Remove the rotigotina patch just before undergoing an MRI or cardioversion to avoid skin burns, as the patch contains aluminum. You can put a new patch on when these tests are finished.

Do not use rotigotina if any of the above options occur. If you are unsure, speak with your doctor, pharmacist, or nurse first.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use rotigotina, as:

• You mustmonitor your blood pressureperiodically while using rotigotina, especially at the beginning of treatment. Rotigotina may affect your blood pressure.
• Yourvisionshould be checked periodically while using rotigotina. If you notice any vision problems between check-ups, inform your doctor immediately.
• If you havesevere liver problems, your doctor may need to adjust the dose. If your liver problems worsen during rotigotina treatment, inform your doctor as soon as possible.
• You may experienceskin reactionscaused by the patch – see ‘Skin problems caused by the patch’ in section 4.
• You may feelextremely drowsy or fall asleep suddenly– see ‘Driving and operating machinery’ in section 2.
• You may experience involuntary muscle contractions that cause abnormal movements or postures, often repetitive (dystonia), abnormal postures, or lateral flexion of the back (also known as pleurostotonos or Pisa syndrome). If this occurs, your doctor may decide to adjust your medication.
• The symptoms ofRestless Legs Syndromemay start before they normally would, be more intense, and involve other parts of the body. If you experience these symptoms before or after starting rotigotina treatment, contact your doctor as you may need your treatment adjusted.

Medications used to treat Parkinson's disease and Restless Legs Syndrome should be gradually reduced or discontinued. Inform your doctor if you experience symptoms such as depression, anxiety, fatigue, sweating, or pain after stopping or reducing your rotigotina treatment.

You may experience loss of consciousness

Rotigotina may cause loss of consciousness. This can occur especially when starting rotigotina treatment or when the dose is increased. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Rotigotina may produce adverse 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 medication and have them read the leaflet.

This includes:

• An overwhelming need to consume large doses of rotigotina or other medications used to treat Parkinson's disease and Restless Legs Syndrome
• Anxiety or an overwhelming need to behave in an unusual way that you cannot control and that may harm you or others – these symptoms are mainly observed in patients with Parkinson's disease
• Abnormal thoughts or behaviors – most of these symptoms occur more frequently in patients with Parkinson's disease.

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

Children and adolescents

This medicationshould notbe administered tochildrenunder 18 years old because its safety and efficacy in this age group are unknown.

Other medications and Dariante

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal medications.

If you are taking rotigotina and levodopa at the same time, some adverse effects may worsen. 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 medications while using rotigotina – as they may reduce its effect:

• ‘Antipsychotic’ medications – used to treat certain mental illnesses
• Metoclopramide – used to treat nausea and vomiting.

Consult your doctor before using rotigotina if you are taking:

• Sedatives such as benzodiazepines or medications used to treat mental disorders or depression
• Medications that lower blood pressure. Rotigotina may lower blood pressure when standing up – this effect may worsen when taking medications to lower blood pressure.

Your doctor will inform you if it is safe to take these medications while using rotigotina.

Use of Dariante with food, drinks, and alcohol

Since rotigotina enters the bloodstream through the skin, taking food or drinks does not affect how this medication is absorbed. You should consult 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 unknown.

Do not breastfeed during rotigotina treatment. This is because rotigotina may pass into breast milk and affect your baby. It is also likely to decrease milk production.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Rotigotina may make you feel extremely drowsy and you may fall asleep suddenly. If this occurs, do not drive. In isolated cases, some people have fallen asleep while driving, resulting in accidents.

Do not use tools or machinery if you feel extremely drowsy – or perform any activity that may put you or others at risk of serious injury.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

What dose of patch to use

Rotigotine is available in patches of different doses that release the medication over 24 hours. The doses are 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h for the treatment of Restless Legs Syndrome.

• Your starting dose of treatment will be a patch of 1 mg/24 h per day.
• From the second week, the daily dose will be increased by 1 mg weekly until reaching the appropriate maintenance dose for you. This is when you and your doctor confirm that your symptoms are adequately controlled and that the medication's side effects are acceptable.
• Follow the instructions indicated by your doctor carefully.
• The maximum dose is 3 mg per day.

If you have to stop taking this medication, see “Stopping treatment with Dariante”in section 3.

How to use Dariante patches:

Rotigotine is a patch that is applied to the skin.

• Check that the used patch has been removed before putting on a new one.
• Put the new patch on adifferent area of the skin each day.
• Leave the patch on the skin for 24 hours, then remove it and put on a new one.
• Change the patchapproximatelyat the same time every day.
• Do not cut the rotigotine patchesinto pieces.

Where to place the patch

Put the adhesive side of the patch on clean, dry, and healthy skin in the following areas, as indicated in the gray areas of the drawing:

• Shoulder or upper arm.
• Abdomen.
• Sides (the laterals, between the ribs and hips).
• Thigh or hip

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 peeling off or coming off

• Do notput the patch on an area where it may be subject tofriction from tight clothing.
• Do notusecreams, oils, lotions, powdersor any otherskin productwhere you will be putting the patch. Nor on top of or near another patch that you are already using.
• If you need to put a patch on an area of the skin where you have hair, at least3 days beforeputting it on that site, you shouldshave(depilate) the skin area.
• If the edges of the patch come loose, you can secure the patch with adhesive tape.

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

• Youmust avoidthe area of thepatch from getting too hot- for example, too much sunlight, saunas, hot baths, hot compresses, or hot water bottles. This is because the medication could be released too quickly. If you think it has gotten too hot, contact your doctor or pharmacist.
• Always check that the patch has not fallen off after activities such asbathing, showering, or exercising.
• If the patch hasirritated your skin, you mustkeep the irritated areaprotected from direct sunlight. This is because exposure to the sun could cause changes in the skin color.

How to use the patch

• Each patch is individually packaged in a sachet.
• Before opening the sachet, you must decide where you will put the new patch and check that the used patch has been removed.
• When you have opened the sachet and removed the disposable cover from the patch, you must put the patch on the 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 the skin. You can also use a small amount of baby oil to remove any remaining adhesive.
• Do not use alcohol or other solvents - such as nail polish remover. This could irritate your skin.

If you use more Dariante than you should

Using higher doses of rotigotine than your doctor has indicated can cause side effects such as nausea or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), confusion, extreme drowsiness, involuntary movements, and seizures. In these cases, inform your doctor or go to the hospital as soon as possible. They will tell you what to do.

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

If you forgot to change the patch at your usual time

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

In both cases, the next day put on a new one at the usual time. Do not use a double dose to make up for the missed doses.

Stopping treatment with Dariante

Do not stop using rotigotine without consulting your doctor first. Sudden discontinuation could cause a condition called ‘neuroleptic malignant syndrome’ that can put your life at risk. The signs include: loss of muscle movement (akinesia), muscle rigidity, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, and decreased consciousness (e.g. coma).

If your doctor tells you to stop treatment with rotigotine, thedaily doseof rotigotine should begradually reduced:

•1 mg every 2 days – if you use rotigotin for Restless Legs Syndrome

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

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

Most likely side effects at the start of treatment

You may experiencenauseaandvomitingat the start of treatment. These side effects are usually mild or moderate and do not last long. You shouldconsult your doctorif the side effects last a long time or if they worry you.

Skin problems caused by the patch

• You may experience redness and itching in the area of the skin 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 more than a few days, is severe, or spreads outside the area covered by the patch.
• Avoid exposure to the sun and sunlamps in areas of skin that show any type of reaction caused by the patch.
• To help prevent skin reactions, the patch should be applied to a different site each day, and only use the same area again after 14 days.

You may lose consciousness

Rotigotine can cause loss of consciousness. This can happen especially when you start treatment with rotigotine or when your dose is increased. Inform your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Inform your doctor if you notice any change in behavior, thought, 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 medicine and have them read this leaflet. Rotigotine can cause anxiety or an urgent need to behave in an unusual way and not be able to control the impulse, attack, or temptation to perform certain actions that may harm you or others – these symptoms are mainly seen in patients with Parkinson's disease.

These actions may include:

• Strong addiction to gambling – even affecting you or your family seriously
• Altered or increased sexual interest and behavior that causes great concern for you and others – for example, increased sexual desire
• Uncontrolled purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal or more than needed to satisfy your appetite).

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

• Abnormal thoughts about reality
• Delusions and hallucinations (seeing or hearing things that are not real)
• Confusion
• Disorientation
• Aggressive behavior
• Agitation
• Delirium.

Inform your doctor if you notice any change in your behavior, thought, or both, as indicated above.Your doctor will tell you how to manage or reduce the symptoms.

Allergic reactions

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

Side effects if using rotigotine for Parkinson's disease

Inform your doctor, pharmacist, or nurse 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
• Irritations of the skin in the area of application of the patch, such as redness and itching

Common: may affect up to 1 in 10 patients

• Falls
• Hypo
• Weight loss
• Swelling in the legs and feet
• Feeling weak (fatigue), feeling tired
• Increased heart rate (palpitations)
• Constipation, dry mouth, stomach discomfort
• Redness, increased sweating, itching
• Dizziness (feeling like you're spinning)
• Seeing or hearing things that are not real (hallucinations)
• Low blood pressure when standing up, high blood pressure
• Difficulty falling asleep, sleep disorders, difficulty sleeping, nightmares, unusual dreams
• Involuntary movements related to Parkinson's disease (dyskinesia)
• Loss of consciousness, feeling dizzy when standing up caused by low blood pressure
• Difficulty controlling the impulse to perform a harmful action, including addiction to gambling, repetitive actions without sense, compulsive purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time), 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
• Low blood pressure
• Increased heart rate
• Increased sexual desire
• Abnormal heart rhythm
• Stomach discomfort and pain
• Generalized itching, skin irritation
• Sudden falling asleep without warning
• Difficulty achieving or maintaining an erection
• Feeling agitated, disoriented, confused, or paranoid
• Abnormal liver test results or elevated liver test results
• Visual disturbances such as seeing colors or lights
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme mainly found in skeletal muscles).

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

• Delusions
• Delirium
• Feeling irritable
• Aggressive behavior
• Psychotic disorders
• Widespread rash
• Involuntary muscle spasms (convulsions)

Unknown: does not know how often they occur

• Anxiety caused by taking high doses of medicines like rotigotina – more than needed for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of rotigotina.
• Diarhea
• Head drop syndrome
• Rhabdomyolysis (a rare severe muscle disorder that causes muscle pain, sensitivity, and weakness and may cause kidney problems)

Inform your doctor, pharmacist, or nurse if you experience any of these side effects.

Side effects if using Dariante for Restless Legs Syndrome

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

Very common: may affect more than 1 in 10 patients

• Headache
• Nausea
• Feeling weak (fatigue)
• Irritations of the skin in the area of application of the patch, such as redness and itching

Common: may affect up to 1 in 10 patients

• Itching
• Feeling irritable
• Allergic reaction
• Increased sexual desire
• Increased blood pressure
• Vomiting, stomach discomfort
• Swelling in the legs and feet
• Drowsiness, falling asleep suddenly without warning, difficulty sleeping, sleep disorders, unusual dreams
• Difficulty controlling the impulse to perform a harmful action, including addiction to gambling, repetitive actions without sense, compulsive purchases or excessive spending
• Episodes of binge eating (eating large amounts of food in a short period of time), compulsive eating (eating more food than normal or more than needed to satisfy your appetite)

Uncommon: may affect up to 1 in 100 patients

• Feeling agitated
• Feeling dizzy when standing up due to low blood pressure

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

• Aggressive behavior
• Disorientation

Unknown: does not know how often they occur

• Anxiety caused by taking high doses of medicines like rotigotina – more than needed for the treatment of the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of rotigotina.
• Seeing or hearing things that are not real (hallucinations)
• Nightmares
• Paranoia
• Confusion
• Psychotic disorders
• Delusions
• Delirium
• Dizziness
• Loss of consciousness, involuntary movements (dyskinesia)
• Convulsions
• Blurred vision
• Visual disturbances such as seeing colors or lights
• Dizziness (feeling like you're spinning)
• Increased heart rate (palpitations)
• Abnormal heart rhythm
• Low blood pressure
• Hypo
• Constipation, dry mouth
• Stomach discomfort and pain
• Diarhea
• Redness, increased sweating
• Generalized itching, skin irritation
• Widespread rash
• Difficulty achieving or maintaining an erection
• Weight loss, weight gain
• Abnormal liver test results or elevated liver test results
• Increased heart rate
• Increased levels of creatine phosphokinase (CPK) (CPK is an enzyme mainly found in skeletal muscles).
• Falls
• Rhabdomyolysis (a rare severe muscle disorder that causes muscle pain, sensitivity, and weakness and may cause kidney problems)

Inform 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 or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the overwrap after “CAD.”The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

What to do with used and unused patches

• Used patches still contain the active ingredient, ‘rotigotina’, which can be hazardous to others. Fold the used patch with the adhesive side inward. Place the patch in the original overwrap and then dispose of it in a safe place, out of the reach of children.
• Medicines should not be thrown down the drain or in the trash. Deposit the containers and medicines you no longer need at the Sigre point..Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Dariante

The active ingredient is rotigotine.

• One patch releases 2 mg of rotigotine every 24 hours. Each patch of 9.2 cm2contains 3.68 mg of rotigotine.

The other components are:

• Backing layer: pigmented polyethylene, polyester coated with vaporized aluminum, orange printing ink.
• Matrix layer,which contains the active substance: tocopherol, paraffin, povidone K90, silicone adhesive.
• Release layer: polyester film coated with fluorosilicone.
• Coating layer: polyester film coated with fluorosilicone.

Appearance of the product and contents of the package

Dariante is a transdermal patch. It is thin, square in shape with rounded corners. The outer part is toasted in color and has the imprint "Rotigotine 2 mg/24 h".

Dariante is available in the following formats:

Containers containing 7, 14, 28, 30, or 84 (a multiple container containing 3 containers of 28) patches, with each patch included in an individual pouch.

Only some sizes of containers may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Exeltis Healthcare, S.L

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares.

Guadalajara, Spain

Responsible manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Rotigotin Luye2 mg/24 Stunden Transdermales Pflaster

Spain:Dariante 2 mg/24 h transdermal patches EFG

Italy:Rotigotina Luye2 mg/ore cerotto transdermico

Last review date of this leaflet:March 2024

Other sources of information

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