Package Leaflet: Information for the User

Adartrel 2 mg Film-Coated Tablets

ropinirol (as hydrochloride)

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What Adartrel is and what it is used for

2. What you need to know before you start taking Adartrel

3. How to take Adartrel

4. Possible side effects

5. Storage of Adartrel

6. Contents of the pack and additional information

The active ingredient in Adartrel is ropinirol, which belongs to a group of medications calleddopamine agonists. Dopamine agonists act in the same way as a natural substance found in the brain, called dopamine.

Adartrel is used in the treatment of moderate to severe symptoms of Restless Legs Syndrome.

Restless Legs Syndrome (RLS) is also known as Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of the body. Normally, these people have uncomfortable sensations in their extremities - sometimes described as “tingling” or “burning”- that can start as soon as they sit or lie down and only improve with movement. These people often have problems staying seated and especially problems sleeping.

Adartrel relieves uncomfortable sensations by reducing the need to move the legs and other extremities.

Do not take Adartrel

• if you areallergicto ropinirol or any of the other components of this medication(including those listed in section6)
• if you have anyserious kidney disease
• if you have anyserious liver disease.
• • Inform your doctorif you think you are in any of these situations.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Adartrel:

• if you arepregnantor think you may be pregnant
• if you are inlactation
• if you areunder 18 years old
• if you have anyliver disease
• if you have anyserious heart disease
• if you have anyserious mental disorder
• if you experience anyimpulsive behavior and/or abnormal behavior(such as anexcessive need to gambleorexcessive sexual behavior)
• if you haveintolerance to some sugars(such as lactose monohydrate).

Inform your doctor if you notice symptoms such asdepression, apathy, anxiety, fatigue, sweating, or painwhen stopping or reducing treatment with Adartrel(known as dopamine agonist withdrawal syndrome or DAWS). If the problems persist after a few weeks,your doctor may need to adjust your treatment.

Inform your doctor if you or your family/caregiver notice that you are developingimpulses or desires to behave in an unusual way for you and cannot resist the impulse, desire, or temptation to carry out certain activities that may harm you or others.This is known as impulse control disorders and may include behaviors such as pathological gambling, excessive eating, or excessive spending, abnormally elevated sexual desire, or an increase in sexual thoughts or feelings.

Inform your doctor if you or your family/caregiver notice that you are developingepisodes of hyperactivity, euphoria, or irritability (symptoms of mania).These may occur with or without symptoms of impulse control disorders (see above).

Other medications and Adartrel

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal medications or those obtained without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medication while taking Adartrel.

Some medications may affect the functioning of Adartrel, or make it more likely that you will experience side effects. Adartrel may also alter the way other medications work.

These medications include:

• theantidepressant fluvoxamine
• medications for othermental disorders, such assulpiride
• metoclopramide, which is used to treatnausea and stomach acid
• hormone replacement therapy (also known asTHS)
• theantibiotics ciprofloxacinorenoxacin
• any other medication that blocks the action of dopamine in the brain
• • Inform your doctorif you are taking or have taken recently any of these medications.

If you are taking the following medications with Adartrel,you may need additional blood tests:

• Anticoagulants (used to reduce blood clotting) such as Warfarin.

Pregnancy and lactation

Adartrel is not recommended during pregnancy,unless your doctor tells you that the benefits for you outweigh any possible risks to the fetus.Adartrel should not be used during lactation,as milk production may be affected.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or think you may become pregnant. Your doctor will recommend what you should do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop taking Adartrel.

While taking Adartrel

Inform your doctor if you or your family members notice that you are developingabnormal behavior(such as anexcessive need to gambleor anincrease in sexual desires and/or behaviors) while taking Adartrel. Your doctor may need to adjust or stop your treatment.

Driving and operating machines

Adartrel may make you feel drowsy. In rare cases, Adartrel may make you feel extremely drowsy, and in some cases, you may fall asleep suddenly without warning.

Adartrel may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machines.

If you experience it:do not drive, do not operate machines, anddo notput yourself in situations where feeling drowsy or falling asleep may put you (or others) at risk of serious harm or death. Do not do these activities until you are no longer affected.

?Consult your doctorif this may affect you.

Smoking and Adartrel

Inform your doctor if you start or stop smoking while taking Adartrel. Your doctor may need to adjust your dose.

Adartrel with food and drinks

If you take Adartrel with food, it is less likely that you will experience nausea or vomiting. Whenever possible, it is best to take it with food.

If your symptoms worsen

Some patients taking Adartrel experience a worsening of their symptoms, for example, symptoms may start earlier than usual or be more intense, or affect other limbs not previously affected, such as the arms, or reappear in the morning.

?Inform your doctor as soon as possibleif you think you have any of these symptoms.

Adartrel contains lactose and sodium

This medication contains lactose monohydrate.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablets; it is essentially “sodium-free”.

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

Do not give Adartrel to children.Adartrel is usually not prescribed to people under 18 years old.

What dose of Adartrel should you take?

You may need some time to determine what dose of Adartrel is best for you.

The initial normal dose is 0.25 mg once a day. After two days, your doctor may increase your dose to 0.5 mg per day for the rest of the week. Then your doctor may gradually increase your dose over the next three weeks, up to a daily dose of 2 mg.

If a dose of 2 mg is not enough to improve the symptoms of RLS, your doctor may gradually increase your dose, up to a maximum of 4 mg per day. After you have taken Adartrel for three months, your doctor may adjust your dose or recommend that you stop treatment.

If you experience that the effects of Adartrel are too strong or too weak, inform your doctor or pharmacist.Do not take more tablets than your doctor has recommended.

Continue taking Adartrel as recommended by your doctor, even if you do not feel better. Adartrel may take several weeks to take effect.

How to take your dose of Adartrel

Take Adartrel once a day.

Swallow the tablets with a glass of water.

You can take Adartrel with or without food. If you take it with food, it is less likely that you will feel nausea.

Adartrel is usually taken before bedtime, but you can take it up to 3 hours before going to bed.

If you take more Adartrel than you should

In case of overdose or accidental ingestion,consult a doctor or pharmacist immediatelyor call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Someone who has suffered an overdose of Adartrel may have some of these symptoms: nausea, vomiting, dizziness (feeling of spinning), drowsiness, fatigue (mental or physical tiredness), feeling of fainting, hallucinations.

If you forgot to take Adartrel

Do not take extra tablets or a double dose to compensate for the missed doses.Take the next dose at the usual time.

If you have forgotten to take your dose for several days, consult your doctor to advise you on how to start taking it again.

If you interrupt the treatment with Adartrel

Do not interrupt the treatment with Adartrel without having consulted beforehand.

Take Adartrel for the time your doctor tells you.Do not suspend treatment unless your doctor tells you to.

If you suddenly stop taking Adartrel, the symptoms of RLS may worsen rapidly.

A sudden interruption of treatment may cause you to develop a condition known as neuroleptic malignant syndrome, which can represent a serious risk to your health. Symptoms include: akinesia (loss of muscular movement), muscular rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, decreased level of consciousness (e.g. coma).

If you need to stop your treatment with Adartrel, your doctor will gradually reduce your dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is more likely that adverse reactions to this medicine will occur at the beginning of treatment or when the dose is increased. They are generally mild in nature and may decrease after taking your medicine for a while.

If you experience any type of side effect, consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet.

Very common side effects

These may affectmore than 1 in 10 patientswho take Adartrel:

• nausea
• vomiting.

Common side effects

These may affectup to 1 in 10 patientswho take Adartrel:

• anxiety
• lightheadedness
• drowsiness
• fatigue (physical or mental tiredness)
• dizziness (sensation of spinning)
• stomach pain
• worsening of SPMS (symptoms may start earlier than usual or be more intense, or affect other unaffected limbs, such as arms, or reappear in the morning)
• swelling of the legs, feet, or hands.

Uncommon side effects

These may affectup to 1 in 100 patientswho take Adartrel:

• confusion
• hallucinations (seeing things that are not really there)
• dizziness or lightheadedness, especially when standing up suddenly (this is due to a drop in blood pressure)
• low blood pressure (hypotension)
• hypotension.

Very rare side effects

A very small numberof patientswho take Adartrel (up to 1 in 10,000) have experienced:

• liver function abnormalities, which have appeared in blood tests
• excessive daytime sleepiness (excessive somnolence)
• sudden onset of sleep (episodes of sudden sleep).

Some patients may have the following side effects (frequency not known: cannot be estimated from available data)

• allergic reactions such as redness, inflammation of the skin with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, hives, or intense itching (see section 2)
• other psychotic reactions in addition to hallucinations such as severe confusion (delirium), irrational ideas (delusions) or irrational suspicions (paranoia)
• aggression
• excessive use of Adartrel (anxiety about taking an excessive dose of dopaminergic medications compared to the necessary dose to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing treatment with Adartrel: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous penile erection.

You may experience the following side effects:

• inability to resist the impulse, desire, or temptation to perform certain actions that may be harmful to you or others, which may include:
• • excessive urge to gamble, despite important personal or family consequences
  • altered or increased sexual interest, and very concerning behavior for you or others, for example, excessive sexual behavior
  • uncontrollable excessive spending or purchases
  • binges (eating large amounts of food in a short period of time) or compulsive eating (eating more food than necessary to satisfy hunger).

• episodes of hyperactivity, euphoria, or irritability.

Inform your doctor if you experience any of these behaviors; they will indicate ways to manage or reduce symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Adartrel

The active ingredient of Adartrel is ropinirole (as hydrochloride).

Each tablet contains 2 mg of ropinirole (as hydrochloride).

The other components are:

• Tablet core : lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Coating film : hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the packaging

Adartrel 2 mg is presented in the form of coated tablets, pentagonal, pink in color, engraved with “SB” on one face and “4893” on the other.

Each package contains 28 or 84 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany, Slovakia, Spain, France, Poland, Portugal, United Kingdom (Northern Ireland), Sweden:Adartrel

Last review date of this leaflet:June 2023

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