Dariorante 6 mg/24 hours transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dariante 4 mg/24 h transdermal patches EFG

Dariante 6 mg/24 h transdermal patches EFG

Dariante 8 mg/24 h transdermal patches EFG

rotigotine

Read the entire leaflet carefully before you start using this 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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

What Dariante is

Dariante contains the active substance rotigotine.

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

What Dariante is used for

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

• Parkinson's disease – Rotigotine Exeltis may be used alone or together with another medicine called levodopa.

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 to undergo magnetic resonance imaging (MRI) (diagnostic imaging of the inside of the body 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 MRI or cardioversion to avoid skin burns, as the patch contains aluminum. You may apply a new patch after these procedures are completed.

Do not use rotigotine if any of the above apply to you. If you are unsure, speak to 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 regularly while using rotigotine, especially at the beginning of treatment. Rotigotine may affect your blood pressure.
• you should have your vision 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 problems caused by the patch’ in section 4.
• you may experience involuntary muscle contractions causing abnormal movements or postures, often repetitive (dystonia), abnormal postures, or lateral bending of the spine (also called pleurosthotonos or Pisa syndrome). If this occurs, your doctor may decide to adjust your medication.
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and use of machines’ in section 2.

If you experience any of these symptoms after starting rotigotine treatment, contact your doctor.

Medicines used to treat Parkinson’s disease 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 treatment with rotigotine 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, caregiver, or doctor are concerned about changes in your behavior, it may be helpful to inform a family member or caregiver that you are using this medicine and that they read the package leaflet.

This includes:

• an overwhelming need to take high doses of rotigotine or other medicines used to treat Parkinson’s disease
• urges or compulsions to behave in unusual ways that you cannot control and that may harm you or others
• abnormal thoughts or behaviors.

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.

Consult 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 cause a drop in blood pressure when standing up – this effect could worsen when taking medicines that 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 breastfeed during treatment with rotigotine. Rotigotine may pass into breast milk and affect your baby. It is also likely to 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 use of machines

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

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

3. How to use Dariante

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

What 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 medication over 24 hours. The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, and 8 mg/24 h for the treatment of Parkinson’s disease.

• You may 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 total daily 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, 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, 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.

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 at approximately the same time each day.
• Do not cut rotigotine patches into pieces.

Where to place the patch

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

• Shoulder or upper arm.
• Abdomen.
• Flanks (sides, 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 apply the patch to an area of damaged or wounded skin – 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 peeling off or detaching

• Do not apply the patch to an area where tight clothing may cause rubbing.
• Do not use creams, oils, lotions, powders, or any other skin products on the area where you will place the patch. Also avoid using them 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) the area at least 3 days before applying the patch.
• If the edges of the patch start to lift, you may secure the patch with adhesive tape.

If the patch falls off, apply a new one to complete the day's treatment, and apply a new patch at your usual time the following day.

• You should avoid exposing the patch area to heat—for example, excessive sunlight, saunas, hot baths, heating pads, or hot water bottles. This is because heat may cause the medicine to be released too quickly. If you think the patch has become 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 protect the irritated area from direct sunlight. This is because sun exposure could lead to 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 previous patch.
• Once you have opened the pouch and removed the protective liner from the patch, 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 and discard the top protective layer, which is brownish in color. A clear protective liner (release liner) covers the adhesive side of the patch.
Hold the patch with both hands, the clear liner facing you. Peel back one side of the protective liner without touching the adhesive surface of the patch with your fingers.
Place the adhesive side of the patch on the skin, then peel off the second part of the non-adhesive lining.
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 water and soap after handling the patch.

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 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 those prescribed by your doctor may cause adverse 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 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, apply a new one 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 a new patch at your usual time the next 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. Suddenly stopping treatment may cause a condition called 'neuroleptic malignant syndrome', which may be life-threatening. Symptoms 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 stop treatment with rotigotine, the daily dose of rotigotine should be gradually reduced:

• Parkinson’s disease – reduce by 2 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 effect.

Most likely adverse effects at the beginning 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 a long time or if you are concerned about them.

Skin problems 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 longer 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 skin areas 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 area 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

Inform your doctor if you notice any changes in behaviour, thinking, or both, as listed below.

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

If your family, caregiver, or 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 to have them read this leaflet. Rotigotine may cause urges or intense desire to behave in an unusual way and inability to control the impulse, attack, or temptation to carry out certain actions that may harm you or others.

These actions may include:

• strong gambling addiction – even seriously affecting you or your family
• altered or increased sex drive and behaviour causing significant concern for you and others – for example, increased sexual desire
• 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.

Inform 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

Inform 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

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 application site of the patch, 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
• flushing, increased sweating, itching
• vertigo (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, strange dreams
• involuntary movements related to Parkinson’s disease (dyskinesia)
• loss of consciousness, feeling dizzy upon standing due to a drop in blood pressure
• inability to control the impulse to perform a harmful action 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
• low blood pressure
• increased heart rate
• increased sex drive
• abnormal heart rhythm
• stomach discomfort and pain
• generalized itching, skin irritation
• sudden onset of sleep 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 rash over the body
• involuntary muscle spasms (seizures)

Not known: frequency cannot be estimated from the available data

• urge to take high doses of medicines such as rotigotine – higher than needed for the treatment of 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, and may lead to kidney problems)

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

Reporting of adverse effects

If you experience any kind of 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 blister 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 into the original sachet and then dispose of it safely, 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 dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dariante

The active substance is rotigotine.

• 4 mg/24 h:

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

• 6 mg/24 h:

One patch releases 6 mg of rotigotine over 24 hours. Each 27.6 cm² patch contains 11.04 mg of rotigotine.

• 8 mg/24 h:

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

Other components are:

• Support layer: pigmented polyethylene, vapour-deposited aluminium-coated polyester, orange printing ink.

• Matrix layer, containing the active substance: tocoferol, paraffin, povidone K90, silicone adhesive.

• Release liner: fluorosilicone-coated polyester film.

• Coating 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 beige and printed with the following label:

4 mg/24 h: “Rotigotine 4 mg/24 h”

6 mg/24 h: “Rotigotine 6 mg/24 h”

8 mg/24 h: “Rotigotine 8 mg/24 h”

Dariante is available in the following pack sizes:

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area member states 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/ora cerotto transdermico
Rotigotina Luye 6 mg/ora cerotto transdermico
Rotigotina Luye 8 mg/ora cerotto transdermico

Date of most recent review of this summary: 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/).