Darior 2 mg/24 hours transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dariante 2 mg/24 h transdermal patches EFG

rotigotine

Read the entire leaflet carefully before you start using the medicine, as it contains important information for you.

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

Contents of the leaflet

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

1. What Dariante is and what it is used for

Dariante is a medicine that contains the active substance dabigatran etexilate. It belongs to a group of medicines called direct oral anticoagulants (DOACs), which help prevent the formation of blood clots.

Dariante is used to:

• Prevent stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (an irregular and often rapid heart rate).
• Treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
• Prevent recurrent DVT and PE in adults.
• Prevent venous thromboembolic events (VTE) in adults who have undergone hip replacement surgery.

This medicine works by blocking a clotting protein in the blood called thrombin, thereby reducing the risk of harmful blood clots.

What Dariante is

Dariante contains the active substance rotigotine.

It belongs to a group of medicines known as "dopamine agonists". Dopamine is a neurotransmitter in the brain that is important for movement.

What Dariante is used for

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

• Parkinson's disease – Dariante may be used alone or together with another medicine called levodopa.
• Restless Legs Syndrome (RLS) – this syndrome may be associated with discomfort in the legs or arms, an urge to move, sleep disturbances, and feeling tired or sleepy during the day. Treatment with Dariante reduces or shortens the duration of these symptoms.

2. What you need to know before using Dariante

Do not use Dariante if:

• you are allergic to rotigotine or to any of the other components of this medicine (listed in section 6)
• you are scheduled for a magnetic resonance imaging (MRI) scan (diagnostic images of the inside of the body created using magnetic energy instead of X-ray energy)
• you require cardioversion (a specific treatment for heart rhythm disturbances).

You must remove the rotigotine patch immediately before undergoing a magnetic resonance imaging (MRI) scan or cardioversion to avoid skin burns, as the patch contains aluminum. You may apply a new patch once these procedures are completed.

Do not use rotigotine if any of the above apply to you. If you are unsure, speak with your doctor, pharmacist, or nurse first.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting rotigotine, because:

• you should have your blood pressure monitored periodically while using rotigotine, especially at the beginning of treatment. Rotigotine may affect your blood pressure.
• your vision should be checked regularly while using rotigotine. If you notice any vision problems between check-ups, inform your doctor immediately.
• if you have severe liver problems, your doctor may need to adjust your dose. If your liver problems worsen during treatment with rotigotine, inform your doctor as soon as possible.
• you may experience skin reactions caused by the patch – see ‘Skin reactions 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 experience involuntary muscle contractions causing abnormal movements or postures, often repetitive (dystonia), abnormal postures, or lateral flexion of the spine (also known as pleurosthotonos or Pisa syndrome). If this occurs, your doctor may decide to adjust your medication.
• symptoms of Restless Legs Syndrome may start earlier than usual, become more intense, or affect other parts of the body. If you experience these symptoms before or after starting rotigotine treatment, contact your doctor, as your treatment may need to be adjusted.

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

You may experience loss of consciousness

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

Changes in behavior and abnormal thoughts

Rotigotine may cause adverse effects that alter 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 inform a family member or caregiver that you are taking this medicine and to have them read the package leaflet.

This includes:

• an overwhelming need to take high doses of rotigotine or other medicines used to treat Parkinson’s disease and Restless Legs Syndrome
• urges or compulsions to behave in unusual ways that you cannot control, which 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 further information, see ‘Changes in behavior and abnormal thoughts’ in section 4.

Children and adolescents

This medicine must not be given to children under 18 years of age, as its safety and efficacy have not been established in this age group.

Other medicines and Dariante

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines without a prescription and herbal medicines.

If you are taking rotigotine and levodopa at the same time, some adverse effects may worsen. These include seeing or hearing things that are not real (hallucinations), uncontrolled movements related to Parkinson’s disease (dyskinesia), and swelling in the legs and feet.

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

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

Talk to 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 upon standing – this effect could worsen when taking medicines to lower blood pressure.

Your doctor will advise you whether it is safe to take these medicines while using rotigotine.

Use of Dariante with food, drinks, and alcohol

Since rotigotine enters the bloodstream through the skin, eating food or drinking beverages does not affect how this medicine is absorbed. You should consult your doctor about whether you can drink alcohol while using rotigotine.

Pregnancy and breastfeeding

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

Do not breast-feed during treatment with 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Rotigotine may make you feel very sleepy and you may fall asleep suddenly. If this happens, do not drive. In isolated cases, some people have fallen asleep while driving, leading to accidents.

Do not operate tools or machinery if you feel very sleepy – or engage in any activity where you or others could be at risk of serious injury.

3. How to use Dariante

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Which patch dose to use

The rotigotine dose you need depends on your condition – see below.

Rotigotine is available in patches of different strengths that release the medicine over 24 hours. The doses are 1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h, and 8 mg/24 h. The 1 mg/24 h and 3 mg/24 h patches are used in the treatment of Restless Legs Syndrome, whereas the 4 mg/24 h, 6 mg/24 h, and 8 mg/24 h patches are used for the treatment of Parkinson's disease. The 2 mg/24 h patch is used for the treatment of both Parkinson's disease and Restless Legs Syndrome.

• You may need to use more than one patch to achieve the dose prescribed by your doctor.
• For doses above 8 mg/24 h (doses prescribed by your doctor exceeding the available strengths), multiple patches should be used to reach the final dose. For example, a daily dose of 10 mg can be achieved by using one 6 mg/24 h patch and one 4 mg/24 h patch.
• Patches must not be cut into pieces.

Treatment of Parkinson's Disease

Patients not taking levodopa – early stages of Parkinson's disease

• Your starting dose will be one 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 ranges between 6 mg and 8 mg per day. This is usually achieved within 3 to 4 weeks.
• The maximum dose is 8 mg per day.

Patients taking levodopa – advanced stages of Parkinson's disease

• Your starting dose will be one 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 ranges between 8 mg and 16 mg per day. This is usually achieved within 3 to 7 weeks.
• The maximum dose is 16 mg per day.

Treatment of Restless Legs Syndrome

• Your starting dose will be one 1 mg/24 h patch per day.
• From the second week onwards, the daily dose will be increased by 1 mg weekly – until the appropriate maintenance dose for you is reached. This is when you and your doctor confirm that your symptoms are adequately controlled and that the medicine's side effects are acceptable.
• The maximum dose is 3 mg per day.

If you need to stop taking this medicine, see "If you stop treatment with Dariante" in section 3.

How to use Dariante patches:

Rotigotine is a patch applied to the skin.

• Make sure 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 the skin for 24 hours, then remove it and apply a new one.
• Change the patch approximately at the same time every day.
• Do not cut rotigotine patches into pieces.

Where to place the patch

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

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

To avoid skin irritation Apply the patch to a different area of skin each day. For example, on the right side of the body one day, and the next day on the left side. Or on the upper part of the body one day, and then on the lower part of the body the next day. Do not apply the patch to the same area of skin twice within 14 days. Do not place the patch on an area of damaged skin or where there is a wound – or on red or irritated skin.

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

To prevent the patch from detaching or coming loose

• Do not apply the patch to an area where it may be rubbed by tight clothing.
• Do not use creams, oils, lotions, powders, or any other skin products on the area where you will place the patch, nor on or near another patch already in use.
• If you need to apply a patch to a hairy area of skin, you should shave (remove hair from) that area at least 3 days before applying the patch.
• If the edges of the patch begin to lift, you may secure it with adhesive tape (bandage).

If the patch falls off, apply a new one to complete the remainder of the day’s treatment, and then apply another new patch at your usual time the next day.

• You should avoid exposing the patch area to heat, such as excessive sunlight, saunas, hot baths, warm compresses, or hot water bottles. This is because heat may cause the medicine to be released more quickly. If you think the area has become too warm, 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 protect the irritated area from direct sunlight. This is because sun exposure could cause changes in skin pigmentation.

How to use the patch

• Each patch is individually packaged in a pouch.
• Before opening the pouch, decide where you will place the new patch and make sure you have removed the used patch.
• Once you have opened the pouch and removed the disposable liner from the patch, you should apply the patch to your skin immediately.

To open the pouch, hold both sides of the pouch with both hands.
Peel apart the layers.
Open the pouch.
Remove the patch from the pouch. Remove the top protective layer, which is cinnamon-colored, from the patch and discard it. A transparent protective liner (release liner) covers the adhesive side of the patch.
Hold the patch in both hands with the transparent film facing you. Peel back one side of the protective film and do not touch the adhesive side of the patch with your fingers.
Place the adhesive side of the patch onto the skin and then peel off the second side of the non-adhesive backing.
Firmly press the patch with the palm of your hand. Hold it in place for about 30 seconds. This ensures the patch is in contact with the skin and the edges adhere properly. Wash your hands immediately with soap and water after handling the patch.

How to remove the used patch

• Gently and carefully remove the used patch.
• Wash the area gently with lukewarm water and mild soap. This will remove any adhesive residue left on the skin. You may also use a small amount of baby oil to remove any remaining adhesive.
• Do not use alcohol or other liquid solvents—such as nail polish remover—as these may irritate your skin.

If you use more Dariante than you should

Using higher doses of rotigotine than prescribed by your doctor may cause adverse effects such as nausea or vomiting, decreased blood pressure, seeing or hearing things that are not real (hallucinations), confusion, extreme drowsiness, involuntary movements, and seizures. In such cases, inform your doctor or go to the hospital as soon as possible. You will be advised on what to do.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to change the patch at your usual time

• If you forget to change the patch at your usual time, do so as soon as you remember. Remove the used patch and apply a new one.
• If you forget to apply a new patch after removing the used one, apply the new patch as soon as you remember.

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

If you stop treatment with Dariante

Do not stop using rotigotine without first consulting your doctor. Stopping abruptly may cause a condition called 'neuroleptic malignant syndrome', which can be life-threatening. Signs include: loss of muscle movement (akinesia), muscle rigidity, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, and reduced level of consciousness (e.g., coma).

If your doctor advises you to discontinue treatment with rotigotine, the daily dose of rotigotine should be gradually reduced:

• Parkinson’s disease – reduce by 2 mg every two days.
• Restless Legs Syndrome – reduce by 1 mg every two days.

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 everyone will experience them. Inform your doctor, pharmacist, or nurse if you notice any adverse effects.

Most likely adverse effects at the start of treatment

You may experience nausea and vomiting at the beginning of treatment. These effects are usually mild or moderate and short-lived. You should consult your doctor if these effects last for a long time or if you are concerned.

Skin reactions caused by the patch

• Redness and itching may occur at the site of skin where the patch has been applied – these reactions are usually mild or moderate.
• These reactions usually disappear within a few hours after removing the patch.
• Consult your doctor if you have a skin reaction lasting more than a few days, if it is severe, or if it spreads beyond the area covered by the patch.
• Avoid exposure to sunlight and sunbeds on areas of skin showing any reaction caused by the patch.
• To help prevent skin reactions, the patch should be applied to a different site each day, and the same site should not be reused until after 14 days.

You may experience loss of consciousness

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

Changes in behaviour and abnormal thoughts

Tell your doctor if you notice any changes in your behaviour, thinking, or both, as listed below.
Your doctor will advise you on how to manage or reduce the symptoms.

If your family or caregiver, or your doctor, are concerned about changes in your behaviour, it may be helpful to inform a family member or caregiver that you are using this medicine and encourage them to read the package leaflet. Rotigotine may cause a strong urge or uncontrollable need to behave in an unusual way and an inability to resist the impulse, attack, or temptation to carry out certain actions that could harm you or others – these symptoms are observed mainly in patients with Parkinson’s disease.

These actions may include:

• intense gambling addiction – even if it seriously affects you or your family
• altered or increased sexual interest and behaviour causing significant concern to you and others – for example, increased libido
• uncontrolled shopping or excessive spending
• binge eating episodes (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 may cause other abnormal behaviours and thoughts, which 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 your behaviour, thinking, or both, as listed above. Your doctor will advise you on how to manage or reduce the symptoms.

Allergic reactions

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

Adverse effects when using rotigotine for Parkinson’s disease

Tell 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
• hiccups
• weight loss
• swelling in the legs and feet
• feeling of weakness (fatigue), feeling tired
• increased heart rate (palpitations)
• constipation, dry mouth, heartburn
• redness, increased sweating, itching
• dizziness (sensation of spinning)
• seeing or hearing things that are not real (hallucinations)
• low blood pressure upon standing, high blood pressure
• difficulty falling asleep, sleep disturbances, difficulty sleeping, nightmares, unusual dreams
• involuntary movements related to Parkinson’s disease (dyskinesia)
• loss of consciousness, dizziness upon standing due to a drop in blood pressure
• inability to control the impulse to perform harmful actions including gambling addiction, meaningless repetitive actions, compulsive shopping or excessive spending
• binge eating episodes (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
• drop in blood pressure
• increased heart rate
• increased sexual desire
• abnormal heart rhythm
• stomach discomfort and pain
• generalized itching, skin irritation
• sudden sleep onset without warning
• inability to achieve or maintain an erection
• feeling agitated, disoriented, confused, or paranoid
• abnormal or elevated liver function test results
• visual disturbances 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 patients

• delusional ideas
• delirium
• feeling irritable
• aggressive behaviour
• psychotic disorders
• widespread skin rash
• involuntary muscle spasms (seizures)

Not known: frequency cannot be estimated from the available data

• anxiety to take high doses of medicines such as rotigotine – more than necessary for treating the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of rotigotine
• diarrhoea
• dropped head syndrome
• rhabdomyolysis (a rare, serious muscle disorder causing muscle pain, tenderness, and weakness, which may lead to kidney problems)

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

Adverse effects when using Dariante for Restless Legs Syndrome

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

Very common: may affect more than 1 in 10 patients

• headache
• nausea
• feeling of weakness (fatigue)
• skin irritation at the patch application site, 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, heartburn
• swelling in the legs and feet
• drowsiness, sudden sleep onset without warning, difficulty sleeping, sleep problems, unusual dreams
• inability to control the impulse to perform harmful actions including gambling addiction, meaningless repetitive actions, compulsive shopping or excessive spending
• binge eating episodes (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
• dizziness upon standing due to a drop in blood pressure

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

• aggressive behaviour
• disorientation

Not known: frequency cannot be estimated from the available data

• anxiety to take high doses of medicines such as rotigotine – more than necessary for treating the disease. This is known as 'dopaminergic dysregulation syndrome' and may lead to excessive use of rotigotine.
• seeing or hearing things that are not real (hallucinations)
• nightmares
• paranoia
• confusion
• psychotic disorders
• delusional ideas
• delirium
• dizziness
• loss of consciousness, involuntary movements (dyskinesia)
• involuntary muscle spasms (seizures)
• blurred vision
• visual disturbances such as seeing colours or lights
• vertigo (sensation of spinning)
• increased heart rate (palpitations)
• abnormal heart rhythm
• drop in blood pressure
• hiccups
• constipation, dry mouth
• stomach discomfort and pain
• diarrhoea
• redness, increased sweating
• generalized itching, skin irritation
• widespread rash
• inability to achieve or maintain an erection
• weight loss, weight gain
• abnormal or elevated liver function test results
• increased heart rate
• increased levels of creatine phosphokinase (CPK) (CPK is an enzyme found mainly in skeletal muscles)
• falls
• rhabdomyolysis (a rare, serious muscle disorder causing muscle pain, tenderness, and weakness, which may lead to kidney problems)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide 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 expiry date stated on the carton and on the sachet after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

How to dispose of used and unused patches

• Used patches still contain the active substance, ‘rotigotine’, which may be harmful to others. Fold the used patch with the adhesive side inwards. Place the folded patch back into the original sachet and then dispose of it in a safe place, out of the reach of children.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a Sigre collection point. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Dariante

The active substance is rotigotine.

• One patch releases 2 mg of rotigotine over 24 hours. Each 9.2 cm² patch contains 3.68 mg of rotigotine.

The other components are:

• Backing layer: pigmented polyethylene, aluminium-vapour-coated polyester, orange printing ink.
• Matrix layer, containing the active substance: tocoferol, paraffin, povidone K90, silicone adhesive.
• Release liner: fluorosilicone-coated polyester film.
• Covering layer: fluorosilicone-coated polyester film.

Appearance of the product and contents of the pack

Dariante is a transdermal patch. It is thin, square-shaped with rounded corners. The outer surface is tan-coloured and printed with the text “Rotigotina 2 mg/24 h”.

Dariante is available in the following pack sizes:

Packs containing 7, 14, 28, 30 or 84 patches (multiple pack containing 3 packs of 28), each patch individually enclosed in a sachet.

Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Rotigotin Luye 2 mg/24 Stunden Transdermales Pflaster
Spain: Dariante 2 mg/24 h transdermal patches EFG
Italy: Rotigotina Luye 2 mg/ora cerotto transdermico

Date of the most recent review of this leaflet: March 2024

Other sources of information

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