ADARTREL 0.25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Adartrel, 0.25 mg, film-coated tablets
3. Adartrel, 0.5 mg, film-coated tablets
4. Adartrel, 2 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What Adartrel is and what it is used for
6. Before you take Adartrel
7. How to take Adartrel
8. Possible side effects
9. How to store Adartrel
10. Contents of the pack and other information
11. What Adartrel is and what it is used for
12. Before you take Adartrel
    1. Do not take Adartrel
    2. Warnings and precautions
    3. Adartrel with other medicines
    4. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal medicines, and other medicines that you are planning to take.
    5. Pregnancy and breast-feeding
    6. While taking Adartrel
    7. Driving and using machines
    8. Adartrel with food and drink
    9. If you experience side effects
    10. Important information about some of the ingredients of Adartrel
13. How to take Adartrel
    1. What dose of Adartrel should you take?
    2. How to take Adartrel
    3. Take one Adartrel tablet once daily.
    4. Swallow the tablet(s) with a glass of water.
    5. If you take more Adartrel than you should
    6. If you forget to take Adartrel
    7. Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
    8. If you stop taking Adartrel
    9. Do not stop taking Adartrel unless your doctor tells you to.
14. Possible side effects
    1. Very common side effects:
    2. Common side effects:
    3. Uncommon side effects:
    4. Rare side effects:
    5. Unknown frequency side effects:
    6. Other side effects:
    7. Tell your doctor if you experience any of these behaviors, to discuss ways to reduce or eliminate them.
    8. Reporting side effects
15. How to store Adartrel
16. Contents of the pack and other information
    1. What Adartrel contains
    2. The active substance is ropinirole (as hydrochloride).
    3. What Adartrel looks like and contents of the pack
    4. Marketing authorization holder and manufacturer
    5. Marketing authorization holder
    6. Manufacturer
    7. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Package Leaflet: Information for the User

Adartrel, 0.25 mg, film-coated tablets

Adartrel, 0.5 mg, film-coated tablets

Adartrel, 2 mg, film-coated tablets

Ropinirole(as hydrochloride)

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

Contents of the pack and other information

1. What Adartrel is and what it is used for

2. Before you take 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 the brain in a similar way to a natural substance called dopamine.

Adartrel is used to treat moderate to severe restless legs syndrome. Restless legs syndrome 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 their body. This is often accompanied by unpleasant sensations such as tingling, burning, or itching in the legs, which can start when sitting or lying down and are relieved by movement. Patients often have difficulty sitting and, in particular, sleeping.

Adartrel relieves the unpleasant sensations and reduces the urge to move the legs and other parts of the body.

2. Before you take Adartrel

Do not take Adartrel

• if you are allergicto ropinirole or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have severe liver disease. You should inform your doctor if you have any of these conditions.

Warnings and precautions

Before taking Adartrel, tell your doctor or pharmacist if:

• you are pregnantor think you may be pregnant,
• you are breast-feeding,
• you are under 18 years old,
• you have liver disease,
• you have severe heart disease,
• you have severe mental health problems,
• you have problems with impulse control(such as compulsions, obsessive thoughts, or addictive behaviors),
• you have intolerance to some sugars(such as lactose monohydrate).

If you stop taking Adartrel or reduce the dose, you may experience side effects such as depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome, or DAWS). If these symptoms persist for more than a few weeks, your doctor may adjust your dose.

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviors (such as an uncontrollable urge to gamble or increased sexual desire). Your doctor may adjust your dose or stop your treatment.

Adartrel with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal medicines, and other medicines that you are planning to take.

Some medicines may affect the way Adartrel works, or Adartrel may affect the way other medicines work. These include:

• fluvoxamine(an antidepressant)
• medicines used to treat other mental health problems, such as sulpiride
• metoclopramide, used to treat nausea and heartburn
• hormone replacement therapy (HRT)
• antibiotics such as ciprofloxacin and enoxacin
• other medicines that block the action of dopamine in the brain.

Tell your doctor if you are taking or have recently taken any of these medicines.

Pregnancy and breast-feeding

Adartrel is not recommended during pregnancyunless your doctor considers it essential. Adartrel is not recommended during breast-feedingas it may affect milk production.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will also advise you if you are breast-feeding or plan to breast-feed.

While taking Adartrel

Tell your doctor if you or your family/caregiver notice any unusual behaviors (such as an uncontrollable urge to gamble or increased sexual desire) while taking Adartrel. Your doctor may adjust your dose or stop your treatment.

Driving and using machines

Adartrel may cause drowsiness. In rare cases, it may causeuncontrollable sleepiness, and sometimes sudden and unexpected sleep attacks, without any prior warning of drowsiness.

While taking Adartrel, you may experience hallucinations (seeing, hearing, or feeling things that are not real). If you experience hallucinations, do not drive or operate machinery.

If you experience any of these symptoms, do not drive, operate machinery, or perform tasks that may put you or others at risk of serious injury or death. Do not perform these tasks until the symptoms have resolved.

Talk to your doctor if this is a problem for you.

Adartrel with food and drink

Taking Adartrel with food may reduce the likelihood of nausea and vomiting. Therefore, it is best to take Adartrel with a meal.

If you experience side effects

In some patients taking Adartrel, restless legs syndrome symptoms may worsen, such as symptoms starting earlier than usual or being more severe or affecting different parts of the body, such as the arms, or recurring in the early morning.

Tell your doctor immediatelyif you experience any of these symptoms.

Important information about some of the ingredients of Adartrel

Adartrel tablets contain a small amount of sugar called lactose monohydrate.If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Adartrel

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask your doctor or pharmacist.

Adartrel is not recommended for children. Adartrel is not usually prescribed for patients under 18 years old.

What dose of Adartrel should you take?

It may take some time to find the right dose of Adartrel for you.

The usual starting dose is 0.25 mg once daily. After 2 days, your doctor may increase the dose to 0.5 mg once daily for the next 5 days of the first week of treatment. Then, your doctor may gradually increase the dose over the next 3 weeks to a dose of 2 mg once daily.

If a dose of 2 mg once daily does not provide adequate control of restless legs syndrome symptoms, your doctor may gradually increase the dose to a maximum dose of 4 mg once daily. After 3 months of treatment with Adartrel, your doctor may adjust the dose or stop treatment.

If you think that the effect of Adartrel is too strong or too weak, talk to your doctor or pharmacist. Do not take more tablets than your doctor has recommended.

Continue to take Adartrel as long as your doctor recommends, even if you do not feel better. It may take several weeks before you experience the beneficial effect of Adartrel.

How to take Adartrel

Take one Adartrel tablet once daily.

Swallow the tablet(s) with a glass of water.

Adartrel can be taken with or without food. Taking Adartrel with food may reduce the likelihood of nausea.

Adartrel is usually taken shortly before bedtime, but the dose can be taken up to 3 hours before bedtime.

If you take more Adartrel than you should

Contact your doctor or pharmacist immediately. If possible, show them the Adartrel packaging.

If you take more Adartrel than you should, you may experience nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations.

If you forget to take Adartrel

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Adartrel for more than a few days, consult your doctor before starting again.

If you stop taking Adartrel

Do not stop taking Adartrel unless your doctor tells you to.

Take Adartrel for as long as your doctor recommends. Do not stop taking it unless your doctor tells you to.

If you stop taking Adartrel suddenly, your restless legs syndrome symptoms may worsen quickly.

Sudden stopping of Adartrel may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include stiffness, fever, unstable blood pressure, rapid heart rate, confusion, and decreased consciousness (such as coma).

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adartrel can cause side effects, although not everybody gets them.

Adartrel side effects are most likely to happen when you first start taking the medicine or when your dose is increased. Side effects are usually mild and become less troublesome after a short time taking the dose.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Very common side effects:

May affect more than 1 in 10 people taking Adartrel.

• nausea
• vomiting

Common side effects:

May affect up to 1 in 10 people taking Adartrel.

• nervousness
• fainting
• drowsiness
• fatigue (mental or physical)
• dizziness
• abdominal pain
• worsening of restless legs syndrome (symptoms may start earlier than usual or be more severe or affect different parts of the body, such as the arms, or recur in the early morning)
• swelling of the legs, feet, or hands

Uncommon side effects:

May affect up to 1 in 100 people taking Adartrel.

• disorientation
• hallucinations (seeing things that are not real)
• dizziness or fainting, especially when standing up quickly (due to low blood pressure)
• low blood pressure (hypotension)
• hiccups

Rare side effects:

Affect less than 1 in 1,000 people taking Adartrel.

• liver problems, shown by abnormal blood test results
• uncontrollable sleepiness during the day (excessive daytime sleepiness)
• sudden sleep attacks without warning (sudden onset of sleep)

Unknown frequency side effects:

• allergic reactions such as red, itchy, swollen skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash, or intense itching
• other psychotic reactions associated with hallucinations, such as acute confusion (delirium), irrational thoughts (delusions), or irrational suspicion (paranoia)
• aggression
• overuse of Adartrel (uncontrollable desire to take higher doses of dopaminergic medicines than needed to control symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing the dose of Adartrel, you may experience depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome, or DAWS)
• spontaneous erections

Other side effects:

• inability to control impulses or desires to perform certain actions that may be harmful to you or others, including:
• uncontrollable urge to gamble despite serious consequences for you or your family
• changed or increased interest in sex and behavior that concerns you or others, such as increased sexual desire
• uncontrolled and excessive shopping or spending
• overeating (eating more food than needed to satisfy hunger) or compulsive eating
• episodes of excessive restlessness, excitement, or irritability

Tell your doctor if you experience any of these behaviors, to discuss ways to reduce or eliminate them.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

5. How to store Adartrel

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 blister after "EXP". The expiry date refers to the last day of that month.

Do not store Adartrel above 25°C.

Store in the original package to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Adartrel contains

The active substance is ropinirole (as hydrochloride).

Each tablet contains 0.25 mg, 0.5 mg, or 2 mg of ropinirole (as hydrochloride). The other ingredients are:

• tablet core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose (type A), magnesium stearate
• coating:0.25 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433) 0.5 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine aluminum lake (E132) 2 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

What Adartrel looks like and contents of the pack

Adartrel 0.25 mgis a white, pentagonal, film-coated tablet with beveled edges, marked with "SB" on one side and "4890" on the other. The pack contains 12 tablets.

Adartrel 0.5 mgis a yellow, pentagonal, film-coated tablet with beveled edges, marked with "SB" on one side and "4891" on the other. The pack contains 28 tablets or 84 tablets.

Adartrel 2 mgis a pink, pentagonal, film-coated tablet with beveled edges, marked with "SB" on one side and "4893" on the other. The pack contains 28 tablets or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

For more information, contact the representative of the marketing authorization holder:

GSK Services Sp. z o.o.
tel. +48 22 576 90 00

Date of last revision of the leaflet:October 2023