DARIANTE 4 mg/24 hours TRANSDERMAL PATCHES

2. What you need to know before you use Dariante

Do not use Dariante if:

• you are allergicto rotigotineor any of the other ingredientsof this medicine (listed in section 6)
• you are going to have an MRI scan(magnetic resonance imaging, a diagnostic test that uses magnetic energy instead of X-rays)
• you need a cardioversion(a 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, pharmacist, or nurse first.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using rotigotine. Because:

• you should have your blood pressurechecked regularly while you are using rotigotine, especially when you start treatment. Rotigotine may affect your blood pressure.
• you should have your eyeschecked regularly while you are using rotigotine. If you notice any problems with your eyes between checks, tell your doctor immediately.
severe liver problems, your doctor may need to adjust your dose. If your liver problems get worse while you are using rotigotine, 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 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.
• you may feel very sleepy or fall asleep suddenly– see ‘Driving and using machines’ in section 2.

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

You may lose consciousness

Rotigotine may cause loss of consciousness. This can happen especially when you start treatment with rotigotine or when you increase the dose. Tell your doctor if you lose consciousness or feel dizzy.

Changes in behavior and abnormal thoughts

Rotigotine 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:

• a strong desire to take large doses of rotigotine or other medicines used to treat Parkinson's disease
• anxiety or a strong desire to behave in unusual ways 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 not known.

Other medicines and Dariante

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 rotigotine 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 you are using rotigotine - because 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 rotigotine if you are taking:

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

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

Using Dariante with food, drinks, and alcohol

Because 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 you are using rotigotine.

Pregnancy and breastfeeding

Do not use rotigotine if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are not known.

Do not breastfeed while you are using rotigotine. This is because rotigotine 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Rotigotine 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 do any activity in which you may put yourself or others at risk of serious injury.

3. How to use Dariante

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

Which patch dose to use

Rotigotine is available in patches of different doses that release the medicine 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 will be a 1 mg/24 h patch per day.
• From the second week onwards, your daily dose will be increased by 1 mg weekly until you reach the right maintenance dose for you. This is when you and your doctor confirm that your symptoms are adequately controlled and the side effects of the medicine are acceptable.
• Follow carefully the instructions given by your doctor.
• The maximum dose is 3 mg per day.

If you have to stop taking this medicine, see “If you stop using Dariante” in section 3.

How to use the Dariante patches:

Rotigotine 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.
• Do not cutthe rotigotine patches.

Where to apply the patch

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

• Shoulder or upper arm.
• Abdomen.
• Sides (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 coming loose or falling off

• Do notapply the patch to an area where it may be rubbed by tight clothing.
• Do notuse creams, oils, lotions, powders, or any other skin productswhere you are going to 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(remove hair) from the area of skin at least 3 days beforeapplying the patch to that site.
• If the edges of the patch come loose, you can secure the patch with a band-aid.

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

• You should avoidheating the patch area- 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 you open the pouch, decide where you are going to 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, 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 lukewarm 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 varnish remover. This could irritate your skin.

If you use more Dariante than you should

Using higher doses of rotigotine 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 using Dariante

Do not stop using rotigotine without talking to your doctor first. Stopping suddenly may cause you to have a condition called ‘neuroleptic malignant syndrome’ which can be life-threatening. The signs include: loss of muscle movement (akinesia), muscle stiffness, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, decreased consciousness (for example, coma).

If your doctor tells you to stop using rotigotine, the daily doseof rotigotine should be gradually reduced:

• 1 mg every 2 days - if you are using rotigotina for Restless Legs Syndrome

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Inform your doctor, pharmacist, or nurse if you notice any adverse effect.

Most Likely Adverse Effects at the Start of Treatment

You may experience nauseaand vomitingat 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

• 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 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 areas of skin 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

Rotigotine can cause loss of consciousness. This can happen especially when starting treatment with rotigotine or when increasing the dose. 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 indicate 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 to read the package insert. Rotigotine can cause anxiety or an overwhelming urge 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 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 purchases 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).

Rotigotine 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.

Inform your doctor if you notice any change in your behavior, thought, or both, as indicated above.

Your doctor will indicate 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.

Adverse Effects if You Use Rotigotine for Parkinson's Disease

Inform your doctor, pharmacist, or nurse if you experience any of the following adverse 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
• hypo
• 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
• vertigo (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 due to 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
• decrease in blood pressure
• increase in 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 levels
• visual disturbances such as seeing colors or lights
• increase in creatine phosphokinase (CPK) levels (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: frequency not known

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this package insert. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dariante

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

Do not use this medicine after the expiration date stated on the packaging and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

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. Place 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 with household waste. Dispose of the packaging and medicines you no longer need in 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 Additional Information

Composition of Dariante

The active ingredient is rotigotine.

• 4 mg/24 h:

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

• 6 mg/24 h:

A patch releases 6 mg of rotigotine every 24 hours. Each patch of 27.6 cm2 contains 11.04 mg of rotigotine.

• 8 mg/24 h:

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

The other ingredients are:

• Supporting layer: pigmented polyethylene, aluminum vapor-coated polyester, orange printing ink.
• Matrix layer, which contains the active substance: tocopherol, paraffin, povidone K90, silicone adhesive.
• Release layer: fluorosilicone-coated polyester film.
• Covering layer: fluorosilicone-coated polyester film.

Appearance of the Product and Package Contents

Dariante is a transdermal patch. It is thin, square in shape with rounded corners. The outer part is brown in color and bears the inscription:

4 mg/24h: "Rotigotine 4 mg/24 h"

6 mg/24h: "Rotigotine 6 mg/24 h".

8 mg/24h: "Rotigotine 8 mg/24 h".

Dariante 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.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares.

Guadalajara, Spain

Manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Rotigotin Luye 4 mg/24 Stunden Transdermales Pflaster

Rotigotin Luye 6 mg/24 Stunden Transdermales Pflaster

Rotigotin Luye 8 mg/24 Stunden Transdermales Pflaster

Spain: Dariante 4 mg/24 h transdermal patches EFG

Dariante 6 mg/24 h transdermal patches EFG

Dariante 8 mg/24 h transdermal patches EFG

Italy: Rotigotina Luye 4 mg/ore cerotto transdermico

Rotigotina Luye 6 mg/ore cerotto transdermico

Rotigotina Luye 8 mg/ore cerotto transdermico

Date of the Last Revision of this Package Insert:March 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/).