Adartrel 0.25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adartrel 0.25 mg film-coated tablets

ropinirole (as hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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, 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 Adartrel is and what it is used for

2. What you need to know before taking Adartrel

3. How to take Adartrel

4. Possible side effects

5. How to store Adartrel

6. Contents of the pack and other information

1. What Adartrel is and what it is used for

The active substance in Adartrel is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in a similar way to a natural substance found in the brain called dopamine.

Adartrel is used to treat moderate to severe symptoms of Restless Legs Syndrome.

Restless Legs Syndrome (RLS) is also known as Ekbom's syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of the body. Typically, these individuals experience unpleasant sensations in their limbs—sometimes described as "tingling" or "burning"—which usually begin when sitting or lying down and are relieved only by movement. These individuals often have difficulty remaining seated and especially problems sleeping.

Adartrel relieves these unpleasant sensations, thereby reducing the need to move the legs and other limbs.

2. What you need to know before taking Adartrel

Do not take Adartrel

• if you are allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have severe liver disease.
  • Tell your doctor if you think you fall into any of these categories.

Warnings and precautions

Talk to your doctor or pharmacist before taking Adartrel:

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have any liver disease
• if you have a serious heart condition
• if you have a severe mental disorder
• if you experience impulsive behaviors and/or abnormal behavior (such as an excessive urge to gamble or excessive sexual behavior)
• if you have intolerance to certain sugars (such as lactose monohydrate).

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with Adartrel (known as dopamine agonist withdrawal syndrome or DAWS). If these problems persist for several weeks, your doctor may need to adjust your treatment.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, urge, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorders and may include behaviors such as pathological gambling, compulsive eating, compulsive spending, abnormally increased libido, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your treatment.

Inform your doctor if you or your family/caregiver notice episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Your doctor may need to adjust or stop your treatment.

• Tell your doctor if you think you fall into any of these categories. Your doctor will decide whether treatment with Adartrel is suitable for you, or whether you need additional monitoring while taking it.

Other medicines and Adartrel

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medicine while on Adartrel.

Some medicines may affect how Adartrel works or make it more likely that you will experience side effects. Adartrel may also alter the way other medicines work.

These medicines include:

• the antidepressant fluvoxamine
• medicines for other mental disorders, such as sulpiride
• metoclopramide, used to treat nausea and acid reflux
• hormone replacement therapy (also called HRT)
• the antibiotics ciprofloxacin or enoxacin
• any other medicine that blocks dopamine action in the brain.
  • Tell your doctor if you are taking or have recently taken any of these medicines.

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

• Vitamin K antagonists (used to reduce blood clotting), such as warfarin.

Pregnancy and lactation

Adartrel is not recommended during pregnancy, unless your doctor determines that the benefit to you outweighs any potential risk to the fetus. Adartrel must not be used during breastfeeding, as milk production may be affected.

? Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you on what to do if you are breastfeeding or planning to breastfeed. Your doctor may recommend that you discontinue treatment with Adartrel.

While taking Adartrel

Inform your doctor if you or your family members notice that you are developing any abnormal behavior (such as an abnormal urge to gamble or an increase in sexual desires and/or behaviors) while taking Adartrel. Your doctor may need to adjust or discontinue your dosage.

Driving and Use of Machines

Adartrel may make you feel sleepy. In very rare cases, Adartrel may make you extremely sleepy, and occasionally may cause you to suddenly fall asleep without warning.

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

If you experience this: do not drive, do not use machines, and do not place yourself in situations where feeling sleepy or falling asleep could put you (or others) at risk of serious harm or death. Do not engage in these activities until you are no longer affected.

? Consult your doctor if 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.

Taking Adartrel with food and drinks

Taking Adartrel with food makes it less likely that you will feel nauseous or vomit. Whenever possible, it is better to take it with food.

If your symptoms worsen

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

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

Adartrel contains lactose and sodium

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Adartrel

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

Do not give Adartrel to children. Adartrel is normally not prescribed for people under 18 years of age.

What dose of Adartrel should you take?

It may take some time to determine the most appropriate Adartrel dose for you.

The usual starting dose is 0.25 mg once daily. After two days, your doctor may increase your dose to 0.5 mg daily for the remainder of the week. Then your doctor may gradually increase your dose over the following three weeks up to a daily dose of 2 mg.

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

If you find 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 directed 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 daily.

Swallow the tablets with a glass of water.

You may take Adartrel with or without food. If taken with food, nausea is less likely.

Adartrel is usually taken before bedtime, but you may 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, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

Someone who has overdosed on Adartrel may experience one or more of the following symptoms: nausea, vomiting, dizziness (spinning sensation), somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take Adartrel

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

If you have missed taking your dose for several days, consult your doctor for advice on how to restart treatment.

If you stop taking Adartrel

Do not stop treatment with Adartrel without first consulting your doctor.

Take Adartrel for as long as your doctor advises. Do not discontinue treatment unless instructed by your doctor.

If you stop Adartrel treatment abruptly, symptoms of restless legs syndrome may worsen rapidly.

Sudden discontinuation of treatment could cause a condition known as neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and decreased level of consciousness (e.g., coma).

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

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.

Adverse reactions to this medicine are more likely to occur at the beginning of treatment or when the dose is increased. They are generally mild in nature and may decrease after you have been taking the medicine for some time.

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

Very common adverse effects

These may affect more than 1 in 10 people taking Adartrel:

• nausea
• vomiting

Common adverse effects

These may affect up to 1 in 10 people taking Adartrel:

• nervousness
• fainting
• drowsiness
• fatigue (physical or mental tiredness)
• dizziness (sensation of spinning)
• stomach pain
• worsening of RLS (symptoms may start earlier than usual, be more intense, affect other limbs not previously involved such as the arms, or reappear early in the morning)
• swelling of the legs, feet, or hands

Uncommon adverse effects

These may affect up to 1 in 100 people taking Adartrel:

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

Rare adverse effects

A very small number of people taking Adartrel (up to 1 in 10,000) have experienced:

• liver function abnormalities, detected in blood tests
• excessive daytime sleepiness (excessive somnolence)
• sudden episodes of falling asleep without prior warning signs of sleepiness (sudden sleep episodes)

Some people may experience the following adverse effects (frequency not known: cannot be estimated from available data)

• allergic reactions such as redness, skin swelling with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, or intense itching (see section 2)
• other psychotic reactions in addition to hallucinations, such as severe confusion (delirium), irrational thoughts (delusions), or irrational suspicions (paranoia)
• aggression
• excessive use of Adartrel (compulsive urge to take higher doses of dopaminergic medication than needed to control motor symptoms, known as dopamine agonist overuse or 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 adverse effects:

• inability to resist the impulse, desire, or temptation to carry out certain actions that may be harmful to yourself or others, which may include:

  • strong urge to gamble excessively, despite significant personal or family consequences
  • altered or increased sexual interest and behavior that is troubling to you or others, such as excessive sexual behavior
  • uncontrollable excessive shopping or spending
  • binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than needed to satisfy hunger)

• episodes of hyperactivity, euphoria, or irritability

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

Reporting of adverse effects

If you experience any type 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adartrel

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adartrel

The active substance in Adartrel is ropinirole (as hydrochloride).

Each tablet contains 0.25 mg of ropinirole (as hydrochloride).

The other components are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Film coating: hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Adartrel 0.25 mg is presented as film-coated pentagonal white tablets, marked with "SB" on one side and "4890" on the other.

Each pack contains 12 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

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

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

Detailed and up-to-date 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/