Darior 3 mg/24 hours transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dariante 1 mg/24 h transdermal patches EFG

Dariante 3 mg/24 h transdermal patches EFG

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 may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 a messenger 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:

• Restless Legs Syndrome (RLS) – this syndrome may be associated with discomfort in the legs or arms, an urge to move, sleep disturbances, and feelings of tiredness or sleepiness during the day. Treatment with rotigotine 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 ingredients 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 disorders).

You must remove the rotigotine patch immediately before undergoing an 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 before using this medicine.

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.
• 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 problems caused by the patch’ in section 4.
• you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in section 2.
• 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 adjustment.

Medicines used to treat 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 is especially possible 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 side effects that change 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 to have them read the package leaflet. Inform your doctor if you, your family, or caregiver notice that you are using the medicine excessively or feel an overwhelming urge to take high doses of rotigotine or other medicines used to treat Restless Legs Syndrome.

For more 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

Tell 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.

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 lower blood pressure when standing up – this effect may be worsened when taking blood pressure-lowering medicines.

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 unborn baby are unknown.

Do not breastfeed during treatment with rotigotine. This is because rotigotine may pass into breast milk and harm your baby. It may also reduce the amount of breast milk produced.

If you are pregnant or breastfeeding, think you might 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 may cause you to 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.

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 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 reaching the appropriate maintenance dose for you. This is when you and your doctor confirm that your symptoms are adequately controlled and that the medicine's adverse effects are acceptable.
• Follow carefully the instructions given by your doctor.
• The maximum dose is 3 mg per day.

If you need to stop taking this medicine, see "If you stop using 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 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.
• 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 apply the patch to 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 reactions caused by the patch" in section 4 for more information.

To prevent the patch from coming loose or detaching

• 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 are going to apply the patch, nor on top of or near another patch you are already using.
• If you need to apply a patch to a hairy area of skin, you should shave (depilatory remove) 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, a new patch should be applied to complete the remainder of the day, and a new patch should be applied at the 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 more quickly. If you think the patch has become too hot, 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 used patch.
• Once you have opened the pouch and removed the disposable liner from the patch, you should apply the patch immediately to the skin.

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 liner facing you. Peel back one side of the protective liner and do not touch the adhesive surface of the patch with your fingers.
Place the adhesive side of the patch onto the skin, then peel off the second half of the non-adhesive liner.
Firmly press the patch with the palm of your hand. Hold it in place for about 30 seconds. This ensures the patch is in full 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 to 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 your doctor has prescribed 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. If this occurs, 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. Suddenly stopping treatment 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:

• 1 mg every two days – if you are using rotigotine 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 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 start 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 problems caused by the patch

• Redness and itching may occur at the site 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 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 sunlamps 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 area should only be reused 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 behavior and abnormal thoughts

Inform your doctor if you notice any changes in behavior, 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 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. Rotigotine may cause urges or intense desires to behave in an unusual way and an 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 if it seriously affects you or your family
• altered or increased sex drive and behavior 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 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 changes in your behavior, 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 if you use rotigotine for Restless Legs Syndrome

Inform 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 irritations at the 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, falling asleep suddenly without warning, difficulty sleeping, sleep problems, unusual dreams
• 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

• feeling agitated
• dizziness upon standing due to a drop in blood pressure

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

• aggressive behavior
• disorientation

Not known: frequency cannot be estimated from the available data

• urge to take high doses of medications 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 colors or lights
• vertigo (spinning sensation)
• increased heart rate (palpitations)
• abnormal heart rhythm
• drop in blood pressure
• hiccups
• constipation, dry mouth
• stomach discomfort and pain
• diarrhea
• redness, increased sweating
• generalized itching, skin irritation
• generalized 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 pain, tenderness, and weakness in the muscles and which may lead to kidney problems)

Inform 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 they are possible adverse effects 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 pack and 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 patch back 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. Return any unused medicines and their packaging to a designated collection point such as a Sigre point. Ask your pharmacist how to dispose of medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dariante

The active substance is rotigotine.

• 1 mg/24 h:

One patch releases 1 mg of rotigotine every 24 hours. Each 4.6 cm² patch contains 1.84 mg of rotigotine.

• 3 mg/24 h:

One patch releases 3 mg of rotigotine every 24 hours. Each 13.8 cm² patch contains 5.52 mg of rotigotine.

The 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.
• Covering layer: fluorosilicone-coated polyester film.

Nature of the product and contents of the pack

Dariante is a transdermal patch. It is thin and square-shaped with rounded corners. The outer surface is brownish in colour and printed with the following label:

1 mg/24 h: “Rotigotina 1 mg/24 h”

3 mg/24 h: “Rotigotina 3 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 marketed.

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 1 mg/24 Stunden Transdermales Pflaster
Rotigotin Luye 3 mg/24 Stunden Transdermales Pflaster

Spain: Dariante 1 mg/24 h transdermal patches EFG
Dariante 3 mg/24 h transdermal patches EFG

Italy: Rotigotina Luye 1 mg/ore cerotto transdermico
Rotigotina Luye 3 mg/ore cerotto transdermico

Date of the most recent review of this leaflet: July 2023

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/).