Adartrel

Leaflet accompanying the packaging: information for the user

Adartrel, 0.5 mg, film-coated tablets

Ropinirole(in the form of hydrochloride)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Adartrel and what is it used for

2. Important information before taking Adartrel

3. How to take Adartrel

4. Possible side effects

5. How to store Adartrel

6. Contents of the packaging and other information

1. What is Adartrel and what is it used for

The active substance of 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 naturally occurring substance called dopamine.
Adartrel is a medicine used to treat moderate to severe restless legs syndrome.
Restless legs syndrome 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 their body. This is often accompanied by unpleasant sensations in the limbs - sometimes described as "skin suffering" or "tingling" - which may start as soon as the patient sits or lies down and only stop after movement. Patients often have trouble sitting, especially sleeping.
Adartrel relieves unpleasant sensations and reduces the urge to move legs and other limbs.

2. Important information before taking Adartrel

When not to take Adartrel

• if the patient is allergicto ropinirole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney disease,
• if the patient has severe liver disease. The treating doctor should be informed in case of these circumstances.

Warnings and precautions

Before starting to take Adartrel, the patient should discuss with their doctor or pharmacist:

• if the patient is pregnantor thinks they may be pregnant,
• if the patient is breast-feeding,
• if the patient is under 18 years of age,
• if the patient has liver disease,
• if the patient has severe heart disease,
• if the patient has severe mental disorders,
• if the patient has particular tendencies and (or) behaviors (uncontrolled urge to gambleor excessive sexual activity),
• if the patient has intolerance to sugars(e.g. lactose monohydrate).

If the patient stops taking or reduces the dose of ropinirole and experiences symptoms such as: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome (DAWS)), they should tell their doctor. If the symptoms persist for more than a few weeks, the doctor may decide to adjust the dose of the medicine.
The patient should inform the treating doctor if they, their family or caregiver notice the patient experiencing unusual behaviorswhile taking Adartrel (such as uncontrolled urge to gambleor increased libido and (or) excessive sexual activity). The doctor may decide to adjust the dose or stop the medicine.
The patient should tell the doctor if they or their family or caregiver notice the patient experiencing episodes of excessive restlessness, excitement or irritability. The doctor may decide to adjust the dose or stop the medicine.
The treating doctor should be informedin case of these circumstances.
If the doctor decides that the patient can take Adartrel, they may recommend additional monitoring during treatment.

Adartrel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking now or have recently taken

including herbal medicines and medicines without a prescription, as well as other medicines the patient plans to take. The patient should remember to inform their doctor or pharmacist about starting to take another medicine while taking Adartrel.
Some medicines may affect the action of Adartrel or increase the risk of side effects. Adartrel may also affect the action of other medicines.
These medicines include:

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

The patient should inform their doctorif they are taking or have recently taken any of these medicines.
Additional blood tests should be performedif the patient is taking the following medicines with Adartrel:

• Medicines from the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Pregnancy and breast-feeding

Adartrel is not recommended during pregnancy, unless the doctor decides that the use of Adartrel will benefit the patient more than the risk to the unborn child. Adartrel is not recommended during breast-feeding, as it may affect milk production in the patient.
The patient should immediately inform their doctor if they are pregnant, think they may be pregnant, or plan to become pregnant. The doctor will also advise if the patient is breast-feeding or plans to breast-feed. The doctor may recommend stopping Adartrel.

While taking Adartrel

The patient should inform their doctor if they or a family member notice the patient experiencing unusual behaviorswhile taking Adartrel (such as uncontrolled urge to gambleor increased libido and (or) excessive sexual activity). The doctor may recommend adjusting the dose or stopping the medicine.

Driving and operating machinery

Adartrel may cause drowsiness. In very rare cases, uncontrolled drowsiness may occur, and sometimes also sudden and unexpected attacks of sleep, not preceded by drowsiness.
While taking Adartrel, hallucinations (seeing, hearing or feeling things that are not there) may occur. If the patient experiences hallucinations, they should not drive or operate machinery.
If the patient suspects that such symptoms may occur: they should not drive, operate machinery orperform tasks that require alertness, as drowsiness or falling asleep may put the patient or others at risk of serious injury or death. The patient should not perform such tasks until the symptoms have resolved.
The patient should talk to their doctorif such a situation is a problem for them.

Taking Adartrel and smoking

The patient should inform their doctor about starting or stopping smoking while taking Adartrel. The doctor may decide to adjust the dose.

Taking Adartrel with food and drink

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

If side effects worsen

In some patients treated with Adartrel, worsening of restless legs syndrome symptoms may occur - for example, symptoms may start earlier than usual or be more intense or affect limbs that were not previously affected, such as arms, or recur in the early morning.
The patient should immediately contact their doctorif they experience any of these symptoms.

Important information about some ingredients of Adartrel

Adartrel tablets contain a small amount of sugar called lactose monohydrate.If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Adartrel

This medicine should always be taken as directed by the doctor or pharmacist.If in doubt, the patient should consult their doctor or pharmacist.
Adartrel should not be taken by children. Adartrel is not usually prescribed to patients under 18 years of age.

What dose of Adartrel should be taken?

Finding the right dose of Adartrel for the patient may take time.
The usual starting dose is 0.25 mg once a day. After two days, the doctor may increase it to 0.5 mg once a day for the next five days of the first week of treatment.
Then the doctor may gradually increase the dose over the next 3 weeks to reach a dose of 2 mg once a day.
If a dose of 2 mg once a day does not provide sufficient control of restless legs syndrome symptoms, the doctor may gradually increase the dose of Adartrel to a maximum dose of 4 mg once a day. After three months of taking Adartrel, the doctor may adjust the dose or recommend stopping treatment.
In case of doses that cannot be administered using this medicinal product, the doctor will check the availability of other suitable medicinal products containing ropinirole.
If the patient feels that the effect of Adartrel is too strong or too weak, they should consult their doctor or pharmacist. The patient should not take more tablets than prescribed by their doctor.
The patient should continue taking Adartrel as directed by their doctor, even if they do not feel any improvement. It may take a few weeks for the beneficial effect of Adartrel to occur.

Taking the dose of Adartrel

The tablet(s) of Adartrel should be taken once a day.

The tablet(s) of Adartrel should be swallowed 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.

Taking a higher dose of Adartrel than recommended

The patient should immediately contact their doctor or pharmacist. If possible, they should show the packaging of Adartrel.
A person who has taken a higher dose of Adartrel than recommended may experience: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, hallucinations.

Missing a dose of Adartrel

The patient should not take extra tablets or a double dose to make up for a missed dose. They should take the next dose at the usual time.

If the patient has not taken Adartrel for more than a few days, they should consult their doctor about restarting Adartrel.

Stopping treatment with Adartrel

The patient should not stop taking Adartrel unless their doctor advises them to do so.

Adartrel should be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor advises them to do so.
If the patient suddenly stops taking Adartrel, restless legs syndrome symptoms may worsen quickly.
Sudden stopping of treatment may cause the patient to experience a so-called malignant neuroleptic syndrome, which can be a serious threat to their health. The symptoms include: akinesia (loss of muscle mobility), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, decreased level of consciousness (e.g. coma).
If it is necessary to stop taking Adartrel, the doctor will gradually reduce the dose taken.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Adartrel can cause side effects, although not everybody gets them.
Adartrel's side effects may occur most often when starting treatment or shortly after increasing the dose. Side effects are usually mild and become less troublesome after a short time of taking the dose.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Very common side effects:

May occur in more than 1 in 10patients taking Adartrel.

• nausea
• vomiting.

Common side effects:

May occur in up to 1 in 10patients 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 intense or affect limbs that were not previously affected, such as arms, or recur in the early morning)
• swelling of the legs, feet or hands.

Uncommon side effects:

May occur in up to 1 in 100patients taking Adartrel.

• disorientation
• hallucinations (seeing things that are not real)
• dizziness or fainting, especially after sudden changes in position (caused by low blood pressure)
• low blood pressure (hypotension)
• hiccups.

Rare side effects:

Occur in a very small number of patientstaking Adartrel (no more than 1 in 10,000):

• liver function disorders, indicated by abnormal blood test results
• uncontrolled drowsiness during the day (excessive daytime sleepiness)
• sudden sleep attacks not preceded by drowsiness (sudden sleep episodes).

The following side effects may occur (frequency not known: cannot be estimated from the available data):

• allergic reactions such as: red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, rash or intense itching (see section 2)
• other psychotic reactions associated with hallucinations, such as: acute confusion (delirium), irrational thoughts (delusions) or irrational suspicion (paranoia)
• aggression
• excessive use of Adartrel (uncontrolled desire to take large doses of dopaminergic medicines, larger than necessary to control motor symptoms, called dopaminergic dysregulation syndrome)
• after stopping or reducing the dose of Adartrel, the following may occur: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome or DAWS)
• spontaneous erection.

The following side effects are possible:

• inability to control impulses or desires to perform certain actions that may be harmful to the patient or others, including:
• uncontrolled urge to gamble despite serious consequences for the patient or their family.
• changed or increased interest in sex and behavior that worries the patient and others, e.g. increased libido.
• uncontrolled and excessive desire to shop and spend money.
• excessive eating (consuming excessive amounts of food in a short time) or compulsive eating (consuming more food than needed to satisfy hunger).
• episodes of excessive restlessness, excitement and irritability.

The patient should contact their doctor if they experience any of these behaviors in order to discuss ways to limit or eliminate these symptoms.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Adartrel

The medicine should be stored out of 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 the month.
Do not store Adartrel above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Adartrel contains

The active substance is ropinirole (in the form of hydrochloride).

Each tablet contains 0.5 mg of ropinirole (in the form of hydrochloride).
The other ingredients are:

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

What Adartrel looks like and contents of the pack

Adartrel 0.5 mgis a yellow, pentagonal, beveled-edged, film-coated tablet, marked "SB" on one side and "4891" 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 Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
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
To obtain more detailed information, the patient should 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: